Your binder contains too many pages, the maximum is 40.
We are unable to add this page to your binder, please try again later.
This page has been added to your binder.
Covington’s internationally leading Food, Drug, and Device Practice encompasses the full range of pharmaceutical, biotechnology, medical device, veterinary, food and beverage, dietary supplement, and cosmetics issues. Through our offices in the United States, Europe, and China and a network of local counsel, we advise trade associations, multinational corporations, and emerging companies on a global basis. We are the only firm ranked “Band 1” for Life Sciences across Chambers’ US, UK, Europe, China, and Global surveys.
In the United States, we represent pharmaceutical, biotechnology, and medical device clients on matters spanning the product life cycle, from product development and clinical trials, through the FDA premarket review process, to postmarketing compliance, including adverse event reporting, Good Manufacturing Practice (GMP) and Quality System requirements, and sales and marketing. We also advise clients on complex issues relating to Hatch-Waxman, biosimilars, and orphan products. As a result of our long and deep work in the area, Covington lawyers have extensive knowledge of the governing laws and regulations, broad-based practical experience with their application, and an intimate knowledge of government regulators and enforcement authorities.
We assist clients in all aspects of food and beverage product development, safety, labeling, and promotion, and have played a key role in the most important legislative developments in the food arena, including advising clients on every new FSMA rulemaking and FDA guidance issued to date. We also have a preeminent regulatory practice relating to veterinary pharmaceuticals, veterinary biological products, pet food, and animal feed. We advise the principal trade association and numerous companies on regulation of cosmetic products.
Our London and Brussels offices include more than twenty-five lawyers who are qualified in various European Union (EU) member states and speak the main languages of the EU. We advise clients on the full range of issues involving pharmaceuticals, biotechnology, devices and diagnostics, foods, cosmetics, and borderline products. We advise on life cycle management planning, pharmacovigilance, EMA transparency policies, and the classification, conformity assessment, and CE marking of medical devices in Europe. We participate in pricing and reimbursement proceedings, including appeals against negative recommendations by the UK’s National Institute of Health and Clinical Excellence, and have in-depth expertise in the EU chemical regime (REACH), which has a significant downstream impact on consumer and health products.
We handle regulatory matters before the European Commission, the European Medicines Agency (EMA), and national regulatory agencies in the European Union. We have actively participated in the development of key pharmaceutical legislation in Europe, and we represent clients in connection with new legislative and regulatory initiatives, including new Medical Device Regulations, Clinical Trials Regulation, Transparency Directive on pricing and reimbursement, and legislation on information to patients.
Our China regulatory team plays a significant role in the firm’s global practice. Our attorneys in Asia and the United States regularly counsel national and multinational companies on the regulatory requirements of the China FDA and provincial FDA authorities. We advise on major developments in the law, regulation, and policy-making processes, including changes to the regulatory frameworks governing food safety, medical devices, pharmaceuticals, and cosmetics, and assist with regulatory advocacy during the notice and comment process before the China FDA.
We represented a major pharmaceutical company in a lengthy investigation by the House Oversight and Government Reform Committee regarding alleged off-label marketing of pharmaceutical products. The investigation included dozens of requests and resulted in the production of tens of thousands of documents.
We represented a world-leading consumer products manufacturer in an investigation by the House Committee on Oversight and Government Reform regarding high-profile recalls of over-the-counter medicines. The investigation included multiple interviews, tens of thousands of documents produced to Congress, and two major hearings, including one at which the company’s chairman and CEO testified.
We represented a major biotechnology company in a congressional investigation by the Senate Finance Committee concerning the price of its breakthrough drug.
Advising distributors of prescription drugs and medical devices concerning compliance with the Food, Drug, and Cosmetic Act, FTC Act, and Lanham Act advertising standards.
Helped influence the development of the FDA Food Safety Modernization Act (FSMA) to minimize unnecessary and costly burdens on industry, and represent clients with respect to food safety laws, health benefits claims, and compliance matters.
Representing Schering-Plough (now Merck) in multi-district class action litigation challenging so-called reverse payment settlements of pharmaceutical patent litigation. Obtained denial of certification of indirect purchaser class, after which indirect purchasers voluntarily dismissed their case. The team previously defeated the FTC at trial in an action on the same facts, and will now have the opportunity to resolve the direct purchaser portion of the case under a recent Supreme Court decision.
Representation of companies and individuals in negotiation of GMP consent decrees involving drugs, biologics, devices, and blood products, including significant consent decree matters for Schering Plough, Genzyme and one of the largest manufacturers of OTC drugs in the U.S.
Illumina in a strategic alliance with Genomics England for a four-year project to decode 100,000 human genomes.
Defense of beverage manufacturer in FTC investigation of substantiation for health benefit claims in advertising.
Advocacy before Congress, FDA, and other federal agencies with respect to emerging regulatory policies on health information technology, research use products, and laboratory developed tests.
Successfully defended the substantiation for health benefit claims made by a food manufacturer facing a challenge before the NAD.
AstraZeneca in an FTC investigation and private antitrust class action litigation concerning settlements of Hatch-Waxman patent litigation involving Nexium.
Counseled leading human and animal food and pharmaceutical manufacturers on all facets of food and drug labeling, marketing and advertising requirements.
Assisted Kos Pharmaceuticals in obtaining Medicare Part D coverage for its previously excluded product.
Conducting due diligence investigations and performing risk assessments to evaluate potential product or toxic tort liabilities associated with pharmaceutical and medical device companies bringing products to market.
Comprehensive review of internet and social media promotion for a leading multinational medical device company.
Representation of International Dairy Foods Association against a class action in Virginia state court alleging deceptive marketing of the potential weight-loss benefits of consuming milk.
Representation of Kentucky Fried Chicken (KFC) against false advertising claims based on a KFC promotion that were asserted as a class action in the Western District of Virginia.
Defense of beverage marketer against allegations of deceptive marketing under the District of Columbia Consumer Protection Procedures Act.
Representation of industry stakeholders in negotiations and legislative process leading to every major amendment to the FDCA since its enactment in 1938.
Prepared influential comments to FDA on behalf of major food trade association clients regarding front-of-pack (FOP) labeling and potential changes to the Nutrition Facts panel.
Successful defense of Pfizer in both the district court and the court of appeals on a series of claims by a relator concerning Genotropin.
On behalf of a major food trade association, helped influence the development of the FDA Food Safety Modernization Act (FSMA) to minimize unnecessary and costly burdens on industry.
Successfully warded off potential California Proposition 65 lawsuits regarding 4-MEI in sodas and lead in juices, and successfully represented companies in litigation regarding lead in chocolate and mercury in tuna.
Represented numerous food and cosmetics companies in responding to demand letters and class actions under the California Consumer Legal Remedies Act and Unfair Competition Law arising out of alleged false and misleading statements on labels and marketing materials.
Advise U.S. cosmetics manufacturers on EU legislation governing animal testing and other issues.
Representation of Amarin in the first known reversal of an FDA denial of a 5-year period of new chemical entity (NCE) exclusivity since the enactment of the Hatch-Waxman Amendments in 1984, in connection with Amarin’s Vascepa drug for lowering triglyceride levels.
Assist client in designing, planning, and establishing a significant new animal health business.
Advise on cutting edge trademark strategies, domain name, social media, and keyword advertising issues, manage U.S. and global portfolios, and provided trademark advisory and prosecution services to leading US and global brand owners, including: American Automobile Association (AAA); AOL, Inc.; Astelllas US; Business Software Alliance; Dale & Thomas Popcorn; Expedia, Inc.; FeraDyne Outdoors; German American Chambers of Commerce; Lewis Bakeries, Inc.; Merck & Co. Inc.; Microsoft Corporation; National Basketball Association; National Football League; National Geographic Society; National Hockey League; Public Broadcasting Service; Phi Beta Kappa Society; Promontory Financial Group; and U.S. Soccer Federation.
Representation of GlaxoSmithKline in global settlement of three investigations relating to off-label promotion, safety reporting and price reporting.
Assisted several pharmaceutical manufacturers in reinstating Medicaid coverage for products dropped from the program by the Centers for Medicare & Medicaid Services (CMS).
Advised a large pharmaceutical company in connection with litigation involving the alleged infringement of patient privacy by a pharmacy chain that collects personal information about prescription drug users.
Assist the client in preparation of a position paper concerning potential amendments to anti-circumvention provisions of Section 1201 of the Digital Millennium Copyright Act and in preparation of comments to the Copyright Office on proposed exemptions to Section 1201.
Assist medical device manufacturer with drafting of standard operating procedures (SOPs) and guidelines for the creation, review, and use of promotional materials.
Serve as principal outside counsel to the Personal Care Products Council, attending Council meetings, preparing draft legislation and Congressional testimony, assisting in regulatory litigation, advising on all aspects of FDA regulation, and providing advice on a wide variety of trade association matters.
Working with pet food and animal feed companies on preparing and filing GRAS notifications, food additive petitions and AAFCO feed ingredient definition applications for animal feed and pet food ingredients.
Advising veterinary pharma companies on issues relating to abbreviated paths to drug approval and issues related to the Center for Veterinary Medicine’s new positioning on growth promotion claims for antibiotics used in human medicine.
Assist animal health companies successfully respond to FDA enforcement actions, including Warning Letters and Form 483 observations.
Developed for a major pharmaceutical client proposals for new potential safe harbors under the federal anti-kickback statute for potential submission to the OIG.
Defense of administrative compliance actions and investigations brought by the USDA under the Animal Welfare Act and assistance with conducting internal investigations related to such actions.
Representation of animal food and drug clients in connection with FDA and USDA import detentions, import refusals, re-exportations and destructions of refused imports, and successful petitions for removal from FDA Import Alerts.
Assisting AbbVie in structuring and negotiating a novel collaboration with the Google-backed life sciences start-up company Calico to form a $1.5 billion to fund a program focused on aging and age-related diseases.
Advised on the advertising of “functional foods” -- foods and dietary supplements with particular health benefits and organic foods.
Counseling leading multinational biopharmaceutical company in doing business in China, including setting and executing on the regulatory and legal strategies for engaging in drug R&D, manufacturing, and sales and marketing.
Advise large device company on regulatory requirements for clinical trials of medical devices in China.
Advising a leading multinational pharmaceutical company on its agreement with a Nasdaq-listed drug manufacturer to develop and market its linaclotide capsule in China.
Advising a U.S. biotech company on its sino-foreign joint venture with a Chinese life sciences company to focus on RNAi-based drug discovery, and related license agreement.
Review of device sales and marketing compliance policies in accordance with a Corporate Integrity Agreement.
Conducting due diligence on China device regulatory matters for a large multinational device company’s acquisition of a large Chinese device company.
Representing a leading U.S. pharmaceutical company to set up a joint venture in China with a Chinese biotech company to research, develop and commercialize a late-stage clinical product for the Asia market.
Advising a leading multinational pharmaceutical company on the acquisition of diabetes drug assets in China and the transfer of related employees from a multinational drug company.
Advise multinational company on regulation of online information on drugs, devices, and food products in China.
Representation of a major pharmaceutical company in its response to a Chinese government commercial bribery investigation in China.
Conducting internal investigation on behalf of a multinational pharmaceutical company into whistleblower allegations of corruption at its Chinese subsidiary.
Representation of coalition of innovative biopharmaceutical manufacturers during the multi-year process that led to enactment of the Biologics Price Competition and Innovation Act of 2010 (BPCIA). Played a similar role for the pharmaceutical industry prior to enactment of the Hatch-Waxman amendments of 1984. Currently advising members of the pharmaceutical industry on FDA regulatory aspects of 21st Century Cures Act and the Senate’s Innovation for Healthier Americans initiative.
Representation of AstraZeneca in its strategic diabetes alliance with Bristol-Myers Squibb, including with respect to collaboration arrangements for the development and commercialization of Amylin Pharmaceuticals’ portfolio of diabetes products following BMS’s acquisition of Amylin in a deal valued at $7 billion (approximately half the cost of which was borne by AstraZeneca).
Representation of AstraZeneca in its $1.26 billion acquisition of Ardea Biosciences. Under the agreement, AstraZeneca will pay $32 per share for all of the outstanding shares of Ardea. AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialization of prescription medicines for gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease. Ardea is a biotechnology company based in San Diego, California, focused on the development of small-molecule therapeutics for the treatment of serious diseases.
Secured a sweeping victory for our clients BMS and Eli Lilly. In 2006, BMS/Lilly hired Consumer Health Information Corporation (“CHIC”) to develop patient education materials for their injectable diabetes drug BYETTA. The contract expressly designated these as works made for hire and assigned CHIC’s interest in these materials to BMS/Lilly. BMS/Lilly later terminated CHIC, and CHIC sued for copyright infringement in D.C. district court in 2008, but voluntarily dismissed the action in 2009. Last July, CHIC sued again in the Southern District of Indiana. In an attempt to avoid the contractual ownership provisions, CHIC alleged “economic duress” and sought rescission. CHIC's infringement claim sought to recover our clients' profits, allegedly “in excess of several billions of dollars.” Judge Pratt dismissed the complaint with prejudice, ruling that two separate statutes of limitation barred CHIC’s infringement claim. First, the Court held that the claim was barred by the Copyright Act’s three-year statute of limitations. The Court accepted Covington’s argument that, because the case turned on ownership, not use, the continuing violation doctrine did not apply. The Court pointedly noted the inequity of allowing CHIC to wait while BMS/Lilly developed a market only to “pounce on the prize” years later. Separately, the Court held that the ownership provisions expressly assigned ownership to BMS/Lilly, and that CHIC’s attempted rescission was barred by California’s four-year statute of limitations. The Court also rejected CHIC’s outrageous attempt to invoke equitable tolling by arguing that its own (former) attorneys had dismissed its 2008 action without its consent and subsequently concealed the dismissal from CHIC.
Co-lead counsel for POM Wonderful in landmark advertising litigation with FTC concerning health claims for food products.
We represented a global manufacturer of advanced medical devices in concurrent investigations in the House and Senate regarding reported injuries to patients. The investigation included parallel regulatory inquiries and significant litigation risks.
We have represented clients in numerous other congressional investigations and oversight hearings, including a major internet services company in an investigation of its practices abroad, a chemical manufacturer in an investigation of the safety of its products, an insurance company in a hearing on the federal long term care insurance program, a financial services company in an investigation of credit card terms, and drug companies in investigations concerning such matters as payments to doctors, marketing practices, generic approvals, drug importation, and drug safety.
Advice to a major pharmaceutical in establishing a healthcare business in the UK, including strategic advice on corporate structure and governance issues and compliance with Vare Quality Commission standards.
Representation of a leading Caribbean-based international beverage company in an LCIA arbitration against the former controlling shareholders of a major European-based company that was acquired by our client and in successfully handling a London-sited UNCITRAL arbitration administered by the LCIA.
Providing litigation counsel to several industry trade associations, including Consumer Healthcare Products Association (CHPA), Pharmaceutical Research and Manufacturers of America (PhRMA), and Distilled Spirits Council of the United States (DISCUS).
Representation of Merck in its $41 billion merger with Schering-Plough.
Representation of King Pharmaceuticals in its $3.6 billion acquisition by Pfizer.
Representation of Salix Pharmaceuticals, Ltd. in its acquisition of Santarus, Inc. for a total value of approximately $2.6 billion. The transaction closed on January 2, 2014. According to Carolyn Logan, Salix President and Chief Executive Officer, “The acquisition of Santarus is a transformational event for Salix and an important milestone in our growth as the leading gastroenterology-focused specialty pharmaceutical company in the United States.”
Salix Pharmaceuticals in its licensing agreement with Alfa Wasserman S.p.A., by which Salix has licensed rights in the United States and Canada to an extended intestinal release (EIR) formulation of rifaximin.
February 10, 2017, Law360
Law360 selected Covington’s Life Sciences practice as a “Practice Group of the Year,” highlighting the firm’s involvement in billion-dollar transactions, success in contentious litigation, and regulatory advice on cutting-edge technology. According to Michael Labson, “What we offer and bring to complicated, complex issues is a mixture of deep subject-matter ...
February 7, 2017, Inside Medical Devices
In January, FDA released a Draft Guidance on Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities (“Draft Guidance,” available here), which provides the Agency’s thinking on communications with payors in two areas: (1) communication of health care economic information to payors regarding approved drugs; and (2) ...
February 1, 2017, 21st Century Cures Act Webinar Series
January 30, 2017
WASHINGTON—Covington represented India-based Piramal Enterprises and its wholly owned Critical Care subsidiary in the UK in its agreement to acquire a portfolio of intrathecal spasticity and pain management drugs from Mallinckrodt LLC.
The purchase price was $171 million, plus an earn-out of up to an additional $32 million. This is the third acquisition that ...
January 25, 2017, 21st Century Cures Act Webinar Series
January 23, 2017, Covington Alert
On Friday, President Trump (through his Chief of Staff) issued a memorandum directing all federal agencies to place a freeze on new or pending federal regulations so that the Trump Administration can review them. This alert explains the scope of this action and analyzes its potential impact on key food regulatory initiatives.
On January 9, 2017, eight Chinese ministries announced a significant new policy that aims to reduce marked-up prices and corruption in multi-tier distribution chains. The policy effectively requires that under most circumstances, at most two invoices may be issued throughout the distribution chain, with one from the manufacturer to a distributor and another from ...
January 19, 2017, Inside Medical Devices
Warning and untitled letters issued to manufacturers of medical products offer unique insight into FDA’s enforcement practices. To help identify themes and trends in the agency’s recent enforcement activity, Covington & Burling has reviewed all warning and untitled letters related to advertising and promotional materials issued in 2016 and tabulated the most ...
January 19, 2017, The Pink Sheet
Michael Labson is quoted by The Pink Sheet in an article regarding FDA’s draft guidance on payor communications. According to Labson, the draft guidance is consistent with changes from the 21st Century Cures Act and evolving case law on the First Amendment, and "provides additional important flexibility for manufacturers to communicate science-based information ...
January 18, 2017, Inside Medical Devices
On January 13, 2017, the U.S. Food and Drug Administration (FDA or Agency) released a discussion paper synthesizing public feedback on FDA’s 2014 draft guidance documents and outlining a possible approach to regulation of laboratory developed tests (LDTs) (Discussion Paper). This approach is intended to “advance the public discussion by providing a possible ...
January 18, 2017, 21st Century Cures Act Webinar Series
January 17, 2017, Covington Alert
January 16, 2017, Medtech Insight
Cándido García Molyneux is quoted in a Medtech Insight article regarding an expected amendment to the Directive on the Restriction of Hazardous Substances (RoHS2). According to García Molyneux, if proposed, non-RoHS compliance electronic medical devices, IVDs and control instruments may be further supplied in the distribution chain or resold after July 22, 2019 ...
January 16, 2017, International Devices & Diagnostics Monitor
Cándido García Molyneux is quoted in an International Devices & Diagnostics Monitor article regarding the European Commission’s plan to allow certain second-hand and refurbished devices that contain hazardous substances to continue to be marketed in the EU beyond July 22, 2019. According to García Molyneux, the ban would greatly restrict the availability of ...
January 15, 2017, Inside Medical Devices
In 2016, the Office of Compliance at the U.S. Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health issued a total of 17 warning letters to medical device manufacturers citing violations of its regulations under 21 C.F.R. Part 803 for adverse event and malfunction reporting and recordkeeping. The 2016 warning letters inform current … ...
January 13, 2017, Medtech Insight
Wade Ackerman participated at the Medtech Showcase and is quoted in a Medtech Insight article regarding the launch of AdvaMed Digital and the increased focus on medtech and digital health. According to Ackerman, having the dedicated sector within AdvaMed will be a positive for future digital-health policy development.
January 11, 2017, The Pink Sheet
Denise Esposito is quoted by The Pink Sheet in an article regarding the difficulty of accelerating pandemic vaccine development. According to Esposito, further complicating the development is the frequent lack of a good human model, as it is typically unethical to expose humans to a disease to test the vaccine's efficacy. She adds that this issue has been a far ...
January 10, 2017, The Pink Sheet
Wade Ackerman participated at the Biotech Showcase and is quoted by The Pink Sheet in an article regarding the increased use of real-world evidence by FDA following the passage of the 21st Century Cures Act. According to Ackerman, FDA will be running a pilot program to evaluate the potential of real-world evidence to support supplemental indications and satisfy ...
January 9, 2017, Covington Alert
This alert reviews trends emerging from the warning and untitled letters issued in 2016 by the Office of Prescription Drug Promotion (OPDP) of the Center for Drug Evaluation and Research (CDER). No warning or untitled letters concerning promotion were issued this year by the Office of Compliance and Biologics Quality (OCBQ) of the Center for Biologics Evaluation ...
January 7, 2017, Inside Medical Devices
On December 28, 2016, CDRH announced the publication of the final guidance “Postmarket Management of Cybersecurity in Medical Devices.” In a separate post, we reported on the January 22, 2016 draft version of this guidance document. The final guidance provides FDA’s recommendations on a risk-based framework for medical device manufacturers to assess and ...
January 5, 2017, Covington Alert
Yesterday, FDA issued a long-anticipated draft guidance intended to help industry comply with the agency’s May 2016 final rules modernizing nutrition labeling. Presented in a question-and-answer format, the draft guidance (Q&A Draft Guidance) provides information related to the compliance date, labeling of added sugars, rounding of the declaration of ...
January 5, 2017, 21st Century Cures Act Webinar Series
January 3, 2017, Inside Medical Devices
The term “industrial scale” appears twice in the draft EU Medical Devices Regulation (“MD Regulation”) in relation to so-called “in-house devices.” The term equally appears in the draft in-vitro diagnostic medical devices (“IVD”) Regulation. To provide perspective on the meaning of “industrial scale” and how the draft MD Regulation’s use of the term may be … ...
January 3, 2017
WASHINGTON—Law360 has named six Covington lawyers as MVPs in their respective practice areas. The awards single out lawyers from across various practice areas based on their “success in high-stakes litigation, complex global matters, and record-breaking deals.”
The Covington lawyers recognized as Law360 MVPs are:
Shara Aranoff, International Trade. Ms. ...
December 22, 2016, Covington Alert
On December 13, 2016, President Obama signed H.R. 34, the 21st Century Cures Act, which became Public Law No. 114-255 (“the Act”). Its enactment represents the culmination of a multi-year bipartisan legislative process spearheaded on the House side by Energy and Commerce Committee Chairman Fred Upton, Ranking Member Frank Pallone, and Rep. Diana DeGette and on ...
December 20, 2016, Law360
Law360 selected Jessica O’Connell as a 2016 Food & Beverage MVP and profiled her involvement in FDA’s decision to review its “healthy” labeling regulations after convincing the agency to refrain from taking legal action against Kind LLC over allegedly misleading labeling of snack bars. According to O’Connell, her intimate understanding of the FDA was helpful as ...
December 19, 2016, Inside Medical Devices
The European Commission is expected to present, in early 2017, a proposal to amend the RoHS2 Directive. The amendment would remove the July 22, 2019 deadline for the supply and resale of non-compliant electronic medical devices, in-vitro diagnostic medical devices (IVDs) and monitoring and control instruments that were first marketed in, or imported into, the … ...
December 12, 2016, Inside Medical Devices
The China Food and Drug Administration (CFDA) has recently released a long-anticipated draft Classification Catalogue of Medical Devices (Draft Catalogue). The Draft Catalogue updates a 2002 Classification Catalogue (Current Catalogue) and is one of the final pieces in the reform of China’s medical device system that has taken place since the 2014 revision of ...
December 7, 2016, Covington Alert
In October 2014, the Nagoya Protocol entered into force. It created a new international regulatory system affecting all life science companies that conduct R&D on biological material such as animals, seeds, flowers, viruses, fragrances, flavonoids, essential oils, enzymes, yeasts, and so on. So far, compliance by companies is progressing slowly due to ...
December 6, 2016, Covignton Alert
On November 8, 2016, the U.S. Food and Drug Administration (FDA) published a final guidance titled Medical Device Reporting for Manufacturers (“Final Guidance”). The guidance explains and clarifies FDA’s interpretations of its regulations under 21 C.F.R. Part 803 for adverse event and malfunction reporting and recordkeeping for manufacturers. On November 30, ...
December 5, 2016, Law Society Gazette
November 28, 2016, Inside Medical Devices
The Centers for Medicare & Medicaid Services (CMS) has now launched the new data reporting process for laboratories under the Protecting Access to Medicare Act (PAMA). Under CMS’s final PAMA rule, applicable laboratories must report private payor rates and other applicable information for certain clinical laboratory tests from a specified six-month data ...
November 20, 2016, Inside Medical Devices
On November 18, 2016, the U.S. Food and Drug Administration (FDA or Agency) announced that it would not finalize the draft guidance entitled Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) (Draft Guidance) prior to the end of the Obama administration. As we previously reported, FDA issued the Draft Guidance on October 3, 2014. … Continue ...
November 16, 2016, Health Law News and Commentary
Michael Labson spoke at an FDA public hearing on behalf of the Pharmaceutical Research and Manufacturers of America and is quoted in a Health Law News and Commentary article regarding constitutional concerns surrounding manufacturer communication of information on off-label uses. According to Labson, the FDA should proceed in "a step-wise fashion that balances ...
November 14, 2016, Regulatory Affairs Professionals Society
Michael Labson spoke at an FDA public hearing on behalf of the Pharmaceutical Research and Manufacturers of America and is quoted in a Regulatory Affairs Professionals Society article regarding regulations on off-label promotions for drugs and devices. According to Labson, safe harbors are needed for communicating certain types of information outside a drug's ...
November 14, 2016, Covington Alert
On November 10, 2016, the Food and Drug Administration (FDA) released its final guidance for industry on the voluntary qualified importer program (VQIP). The final guidance builds upon draft guidance issued in June 2015, as part of FDA’s implementation of the FDA Food Safety Modernization Act of 2011 (FSMA) mandate to establish a voluntary, fee-based program to ...
November 11, 2016, FDA Week
Michael Labson spoke at an FDA public hearing on behalf of the Pharmaceutical Research and Manufacturers of America where he laid out a stepwise approach PhRMA believes FDA should take regarding off-label communication, and is quoted in an FDA Week article. According to Labson, FDA should create three safe harbors for different types of communication: first, ...
November 11, 2016, Drug Industry Daily
Michael Labson spoke at an FDA public hearing on behalf of the Pharmaceutical Research and Manufacturers of America and is quoted in a Drug Industry Daily article providing key points from the meeting on off-label communication. According to Labson, communication should be rooted in scientifically-sound findings.
November 4, 2016, FDA Week
Michael Labson spoke at the FDLI Annual Advertising Conference and is quoted in an FDA Week article regarding communication between drug makers and payers under a section of the FDA Modernization Act. According to Labson, first amendment jurisprudence may make concerns over FDAMA 114 a non-issue. "If the first amendment idea that you have a constitutional right ...
November 4, 2016, EU Food Law
Brian Kelly is quoted in an EU Food Law article regarding the UK High Court ruling requiring its government to have Parliamentary approval before triggering Article 50. According to Kelly, the decision added uncertainty around Brexit, although it did also present a lobbying opportunity for the industry as well.
“The immediate impact of the judgment is that, as ...
November 4, 2016, FDAnews
John Balzano participated in an FDAnews webinar and is quoted in an article regarding China FDA’s proposed expanded requirements for medical device recalls and higher fines for manufacturers that fail to issue recalls. According to Balzano, to be eligible for the accelerated pathway for breakthrough medical devices, the intellectual property for the device needs ...
November 3, 2016, The Pink Sheet
Brian Kelly is quoted by The Pink Sheet in an article regarding the UK High Court’s ruling that its government does not have the right to trigger Article 50 without Parliamentary approval. According to Kelly, the judgment presented "an opportunity for individual companies and the [life sciences] industry to engage with members of Parliament to ensure that their ...
November 2, 2016, Covington Alert
Last week, FDA released a draft guidance1 clarifying requirements for the “disclosure statement” provisions of its four major Food Safety Modernization Act (FSMA) rules. Entities subject to these provisions must disclose, in documents accompanying the food, that certain hazards have not been controlled. The draft guidance provides insight into the circumstances ...
October 28, 2016, FDA Week
Wade Ackerman spoke at a DIA conference on October 24 and is quoted in an FDA Week article regarding combination product reform.
According to Mr. Ackerman, there has been strong bipartisan support for 21st Century Cures and Medical Innovation bills. However, if combination product language does not get passed in this Congress, Ackerman also pointed to the FDA ...
October 21, 2016
WASHINGTON—Covington represented India-based Piramal Enterprises and its wholly owned Critical Care subsidiary in the UK in the acquisition of five anesthesia and pain management injectable products from Janssen Pharmaceutica NV, in an all cash deal for an upfront consideration of US$155 million, and up to an additional US$20 million.
The products to be acquired ...
October 17, 2016, Law360
October 13, 2016, Covington Alert
On September 21, 2016, the National Institutes of Health (NIH) published its final rule, Clinical Trials Registration and Results Information Submission, 42 C.F.R. Part 11. Under Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA), “responsible parties” for specified clinical trials of FDA-regulated drug and device products must submit ...
October 6, 2016, EP Vantage
Grant Castle is quoted in an EP Vantage article regarding the effect of Brexit on life science funding and strategy. According to Castle, “Particularly if the UK heads for a ‘hard Brexit,’ the UK will be a less attractive venue for investment by pharma. It’s one of the sad side effects of all this.”
October 2016, Bio-Science Law Review
September 29, 2016, Inspection Insider
John Balzano participated in an FDAnews webinar and is quoted in an Inspection Insider article regarding China FDA’s proposed rules that increase penalties for devicemakers that fail to issue recalls. Commenting on the agency’s “accelerated pathway” for breakthrough medical devices, Balzano says that in order to be eligible for the pathway, the devices’ ...
September 27, 2016, Covington Alert
Today, the Food and Drug Administration (FDA) issued a guidance document communicating its intent to exercise enforcement discretion regarding certain uses of “healthy” in food labeling for products that do not meet FDA’s current “healthy” regulatory requirements but that contain predominantly “good fats” or are a good source of certain nutrients (“healthy” ...
September 22, 2016
WASHINGTON—Pamela Forrest has joined Covington in its Food, Drug, and Device practice, resident in Washington.
Ms. Forrest has more than 20 years of experience advising clients on a broad range of FDA regulatory issues. Her practice focuses on FDA medical device matters, including premarket review, product recalls, medical device reporting (MDR), Quality System ...
September 21, 2016, Covington Alert
On September 21, 2016, the Court of Justice of the EU (CJEU) delivered its judgment in Case C-592/14 European Federation for Cosmetic Ingredients v UK Secretary of State for Business. The Court has ruled that animal tests performed outside the European Union (EU) to comply with non-EU rules should not be used for the product safety assessment to gain access to ...
September 16, 2016, Food Chemical News
Jessica O’Connell participated in the Food and Drug Law Institute’s Food Advertising, Labeling, and Litigation Conference and is quoted in a Food Chemical News article regarding “healthy” claims. According to O’Connell, FDA considers “healthy” not to be an implied nutrient content claim when it refers to general dietary guidance.
September 16, 2016, Covington Alert
On September 12 and 13, 2016, the U.S. Food and Drug Administration (FDA) held a two-day public hearing to obtain input on four draft guidance documents issued by the agency concerning human cells, tissues, and cellular and tissue-based products (HCT/Ps).
September 12, 2016, International Devices & Diagnostics Monitor
John Balzano participated in an FDAnews webinar and is quoted in an International Devices & Diagnostics Monitor article regarding China’s changing device regulations. According to Balzano, "Overall, they're going to want to make sure that they have a regulatory structure in place that facilitates the most innovative applications and the applications for devices ...
September 9, 2016, Law360
Wade Ackerman and Denise Esposito are quoted in a Law360 article regarding Ackerman’s recent arrival as a partner in the firm’s Food, Drug, and Device practice. According to Ackerman, he’d like to serve as bridge between Washington, D.C., and Los Angeles for the firm. For a food and drug attorney, Covington is the place to go, given its “long history of having a ...
September 7, 2016, Covington Alert
Yesterday, FDA published its final rule regulating certain active ingredients found in over-the-counter (“OTC”) consumer antiseptic wash products that are intended to be used with water and rinsed off after use, such as hand or body washes, which FDA refers to as “consumer antiseptic washes” (the “Final Rule”). In the Final Rule, FDA deems 19 active ingredients ...
September 1, 2016, The Recorder
Wade Ackerman and Robyn Polashuk are quoted in a Recorder article regarding the growth of the firm’s LA office, which includes Ackerman’s recent arrival. "We're in a period of unprecedented change in the way products are regulated, and a lot of companies are on the West Coast,” said Ackerman.
Commenting on West Coast business, Polashuk says, “It hasn't been, ...
August 31, 2016
LOS ANGELES—Wade Ackerman has joined Covington as a partner in its Food, Drug, and Device practice, resident in Los Angeles.
Until June 2016, Mr. Ackerman served as Senior FDA Counsel to the U.S. Senate Health, Education, Labor & Pensions Committee. In this role, he has been intimately involved in legislative initiatives, oversight hearings, and other Senate ...
August 26, 2016, Nutritional Outlook
Brian Kelly is quoted in a Nutritional Outlook article regarding the ways Brexit could affect the supplement industry. According to Kelly, “If the UK went down a Norway or EEA model approach, it’s very unlikely that there’d be any material change to the legal position.” He continues, “The UK’s implementation of EU existing food law would remain valid and the UK ...
August 26, 2016, Covington Alert
Earlier this week, the Center for Veterinary Medicine (CVM) of the Food and Drug Administration (FDA) published Draft Guidance for Industry #235, “Current Good Manufacturing Practice Requirements for Food for Animals,” as part of the agency’s implementation of the Food Safety Modernization Act (FSMA). The draft guidance contains information designed to help ...
Earlier this week, the Center for Veterinary Medicine (CVM) of the Food and Drug Administration (FDA) published Draft Guidance for Industry No. 239, “Human Food By-Products for Use as Animal Food” as part of the agency’s implementation of the Food Safety Modernization Act (FSMA). The draft guidance describes the regulatory requirements — including the ...
August 25, 2016
Earlier this week, FDA released five chapters of a multi-chapter draft guidance on hazard analysis and risk-based preventive controls for human food. The long-awaited draft guidance is intended to help industry comply with certain requirements of the agency’s final rule for preventive controls for human food (PC rule) under the Food Safety Modernization Act ...
August 24, 2016, Law360
August 18, 2016, Covington Alert
Nineteen years after first publishing its proposal, FDA published in yesterday’s Federal Register its final rule on substances generally recognized as safe (GRAS) for their intended use in human and animal food. This Alert addresses the final rule as it applies to food for animals. For an analysis of how the final rule will affect human food, see our Alert “FDA ...
August 17, 2016, Covington Alert
This morning, August 17, 2016, FDA published in the Federal Register its final rule on substances generally recognized as safe (GRAS) for their intended use in food. Coming nineteen years after the proposed rule, under which industry has effectively been operating for some time, the final rule mostly codifies the status quo. The final rule formalizes, through ...
August 15, 2016, Covington Alert
On August 11, 2016, FDA published its long-awaited revised draft guidance on Dietary Supplements: New Dietary Ingredient Notifications and Related Issues. Like the 2011 draft it replaces, the revised draft guidance is intended to help a dietary supplement company decide (1) whether a substance is a dietary ingredient; (2) when a new dietary ingredient (NDI) ...
August 5, 2016, FDA Week
Grant Castle is quoted in an FDA Week article regarding the likelihood that the UK will remain part of the Mutual Reliance Initiative between the U.S. and EU. "If the UK does Brexit, but executes the European Economic Area (EEA) Agreement, as Norway, Iceland and Liechtenstein have done, it would continue to implement all new EU pharmaceutical rules and ...
July 28, 2016, Food Dive
Jessica O’Connell spoke at the IFT expo and is quoted in a Food Dive article regarding medical food products. O’Connell, commenting on how companies have tried to develop medical food, said the most common warning letters sent out by the FDA since 2006 use the words no “distinctive nutritional requirement” for the disease or condition. She added that since 2009, ...
July 18, 2016, Covington Alert
On July 14, 2016, FDA published its amended final regulations for registration of domestic and foreign food facilities under the Food Safety Modernization Act (FSMA). Registration is required for such facilities that manufacture/process, pack, or hold food for human or animal consumption. The final rule codifies a number of provisions that were mandated by FSMA ...
July 15, 2016, Covington Alert
Yesterday, the United States House of Representatives passed Bill S.764 (“Joint Bill”), which will amend the Agricultural Marketing Act of 1946 to add Subtitle E: “National Bioengineered Food Disclosure Standard,” and Subtitle F: “Labeling of Certain Food.” The United States Senate passed the same bill last week on July 7, 2016. The Joint Bill, if signed into ...
July 14, 2016, Bloomberg BNA
Miriam Guggenheim is quoted in a BNA article regarding legislation passed by Congress creating a national standard for food makers to disclose genetically-modified ingredients. According to Guggenheim, while there is considerable will in the administration to resolve the GMO labeling issue, agency resources would also play a role in the rulemaking timeline. ...
July 11, 2016, Covington Alert
The UK recently voted to leave the European Union in an advisory referendum. The impact of Brexit on medical devices regulation in the medium-to-long term will very much depend on the form a post-Brexit UK will take, the relationship that the UK chooses to have with the EU, and indeed the relationship that the EU is willing to accept. That will not become clear ...
June 30, 2016, Covington Alert
Last week, the UK voted to leave the European Union in an advisory referendum. The impact of Brexit on food and drink regulation in the medium-to-long term will very much depend on the form a post-Brexit UK will take, the relationship that the UK chooses to have with the EU, and indeed the relationship that the EU is willing to accept. That will not become clear ...
June 28, 2016, Bloomberg
Grant Castle is quoted in a Bloomberg article regarding the implications of Brexit on the future of the pharmaceutical industry and the drug approval process. According to Castle, the best that the UK regulator could hope for would be an observer status on European Medicines Agency committees. That loss of influence could make the UK less appealing, because it ...
June 27, 2016, The Legal Intelligencer
Grant Castle is quoted in a Legal Intelligencer article regarding the regulatory impact of Brexit. Commenting on the Food and Drug sector, Castle says, “The UK will inevitably diminish in significance when it comes to the regulation of pharmaceuticals and a venue where drug companies are going to want to be based. Historically, U.S. companies wanted to operate ...
June 27, 2016, Covington Alert
Last week, the UK voted in an advisory referendum to leave the European Union. The next steps are not yet clear, but the referendum may have significant implications for the pharmaceutical industry in the UK and for international companies operating in the UK. Its impact will very much depend on the form a post-Brexit UK will take, the relationship that the UK ...
June 24, 2016, Politico
Grant Castle is quoted in a Politico article regarding the effect of Brexit on the future location of the European Medicines Agency. Castle predicts that the EMA is inevitably going to leave the UK. “Given the strength of feeling on immigration,” it looked unlikely the country would opt for a European Economic Area relationship, since that would mean continuing ...
June 22, 2016, Webinar
June 2, 2016, Covington Alert
On June 1, 2016, the FDA announced draft guidance on voluntary sodium reduction targets that could have a substantial effect on food manufacturers and restaurants. The Draft Guidance proposes short-term and long-term targets for various categories of commercially processed, packaged, and prepared foods, as well as recommended upper bounds for sodium in each food ...
May 31, 2016, Covington Alert
On May 27, 2016, FDA finalized its seventh and final food safety rule under the Food Safety Modernization Act (FSMA), which will become new 21 C.F.R. Part 121. The Intentional Adulteration rule establishes requirements to help protect food against adulteration from acts intended to cause wide-scale harm to public health, including acts of terrorism. For the ...
May 25, 2016, Law360
Miriam Guggenheim is quoted in a Law360 article regarding the FDA’s new rule requiring companies to include information about added sugars on nutrition labels. According to Guggenheim, "There will be those who assert that FDA has not met its First Amendment burden to justify the compelled commercial speech." She continues, "A number of recent cases have ...
May 23, 2016, Covington Alert
On Friday, May 20, 2016, FDA issued two final rules to revise the nutrition labeling requirements for conventional foods and dietary supplements—the first major revisions to the nutrition labels since they were originally required over 20 years ago. Recognizing a shift in the average American’s consumption habits and understanding of the Nutrition Facts label, ...
May 16, 2016, Covington Alert
Last week, FDA finalized its guidance for industry about medical foods, which it issued in draft form in August 2013. This guidance incorporates most of the principles that FDA articulated in the 2013 draft guidance regarding the agency’s position on the definition of medical foods, the scope of lawful uses of medical foods, and other labeling and safety ...
May 12, 2016, Webinar
May 11, 2016, This article was published in Scrip Regulatory Affairs
May 8, 2016, Financial Times
Peter Bogaert and Grant Castle are quoted in a Financial Times article regarding the effect Brexit would have on the UK pharma industry. According to Bogaert, commenting on the important relationship between the European Medicines Agency and the UK’s Medicines and Healthcare Products Regulatory Agency, “Brexit would be a loss for both sides.”
Castle adds that ...
April 25, 2016, International Devices & Diagnostics Monitor
John Balzano’s remarks from an FDAnews webinar are quoted extensively in this article on changes to Chinese device regulations. According to Balzano, it is important to consider a host of issues, such as whether the device will be manufactured in China. Understanding the finer points of the Chinese FDA guidances "can influence whether your application gets ...
April 20, 2016, Covington Alert
The United States Department of Veterans Affairs (“VA”) recently announced a significant change in policy that will allow it to purchase drug products that were previously unavailable due to the Trade Agreements Act (“TAA”) because they were manufactured in countries with whom the United States does not have a procurement agreement in place. The VA has issued a ...
April 15, 2016, Law360
April 14, 2016, Covington Alert
It has now been a full year since the Food and Drug Administration (“FDA”) approved the first biosimilar product to proceed under the new abbreviated biological pathway. With recent spotlights on the cost of pharmaceutical drug products, the potential of biosimilars to offer patients additional and more affordable choices has been widely discussed. Most ...
April 7, 2016, Covington Alert
Yesterday, FDA published in the Federal Register its final rule establishing sanitary transportation requirements for both human and animal food. The rule is intended to ensure that food transportation practices do not create food safety risks. FDA provides a flexible, risk-based approach that largely aims to allow the transportation industry to continue to use ...
April 1, 2016, Covington Alert
Strict EU rules enforce compliance with the principles on access and benefit sharing under the Nagoya Protocol. The rules affect all companies doing research on genetic resources, such as plants, bacteria and viruses, and related traditional knowledge. They in particular are relevant for the pharmaceutical, medical devices, cosmetics, biocides and foods ...
March 31, 2016, Update
March 24, 2016
NEW YORK - Covington advised the underwriters in the $45 million initial public offering of common stock of Senseonics Holdings, Inc. The offering closed on March 23, 2016. Shares of Senseonics trade on the NYSE MKT under the ticker “SENS.”
Senseonics develops continuous glucose monitoring systems for patients with diabetes. Its Eversense product consists of ...
March 22, 2016, Covington Alert
February 26, 2016, Nutra Ingredients
Brian Kelly is quoted extensively in this Nutra Ingredients article discussing the UK Psychoactive Substances Act and its possible effect on the food supplements industry. According to Kelly, “Despite criticism and proposed amendments about unintended targets the law has been pushed through. It’s a poorly drafted law when it comes to food.” He continues, “You ...
February 17, 2016, Politico
Grant Castle and Robin Blaney are quoted in this Politico article discussing the potential impact of “Brexit” on the pharmaceutical sector in the UK and Europe. According to Castle, the “only rational alternative” to EU membership is for the U.K. to become a member of the European Economic Area, as this arrangement would make it so the practical and operational ...
February 2016, European Journal on Risk Regulation
January/February 2016, Update
December 2, 2015, Webinar
November 25, 2015, Covington Alert
November 23, 2015
LONDON, November 23, 2015 — Covington represented Allergy Therapeutics, the AIM-listed specialty pharmaceutical company specializing in allergy vaccines, in the placement of ordinary shares raising approximately £11.5 million. The placement was conducted through an accelerated bookbuilding process with Panmure Gordon & Co acting as financial adviser, nominated ...
November 17, 2015, Covington Alert
November 16, 2015, Law360
November 9, 2015
WASHINGTON, DC, November 9, 2015 - Denise Esposito, who served as Chief of Staff to the Commissioner of the US Food and Drug Administration and FDA’s Deputy Chief Counsel for drugs and biologics, has joined Covington as a partner and co-chair of its Food & Drug practice group.
“Denise has played a central role on issues of critical importance to our clients in ...
October 29, 2015, Covington Alert
September 18, 2015, Covington Alert
September 17, 2015, Covington Alert
September 14, 2015, Covington Alert
August 11, 2015, Covington Alert
August 7, 2015, Covington Alert
August 2015, JUVE
Quoting Adem Koyuncu on anti-corruption issues in the pharma sector.
August 2015, An Extract from The European Antitrust Review 2016
July 29, 2015
WASHINGTON, DC, July 29, 2015 – Sanofi and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) have entered into a new global collaboration to discover, develop and commercialize new antibody cancer treatments in the field of immuno-oncology. Sanofi has committed to an initial investment of up to $2.17 billion in the exclusive collaboration, including $640 million in ...
July 28, 2015, Covington Alert
7/27/2015, Covington Alert
July 10, 2015, Covington Alert
6/18/2015, Covington Alert
June 17, 2015, The New York Times
The firm is mentioned in this article regarding it's representation of Allergan in its $2.1 billion acquisition of Kythera Biopharmaceuticals.
June 17, 2015, Life Sciences Essentials Webinar Series
June 8, 2015, Covington Alert
June 3, 2015, Covington Alert
May 29, 2015
WASHINGTON, DC, May 29, 2015 — Covington scored a victory for Amarin Pharmaceuticals Ireland Limited this week when a federal judge vacated the U.S. Food and Drug Administration’s earlier decision that Amarin’s new drug Vascepa was not entitled to a five-year period of market exclusivity. It is the first known successful challenge to FDA’s denial of ...
May 20, 2015, Covington E-Alert
April 29, 2015, Covington E-Alert
April 21, 2015, InsideMedicalDevices Blog
April 20, 2015
NEW YORK — Covington advised the underwriters in the $76.8 million initial public offering of common stock of Cidara Therapeutics, Inc. Shares of Cidara trade on the NASDAQ Global Market under the ticker “CDTX.”
Cidara is a biopharmaceutical company focused on the discovery, development and commercialization of anti-infectives for treatment of diseases ...
April 10, 2015, Am Law's The Litigation Daily
Covington's Paul Schmidt and Michael Imbroscio were named "Litigators of the Week" by AmLaw for their successful representation of Hoffmann-La Roche Inc.:
"Not so long ago, Hoffmann-La Roche Inc. faced a grim reality in sprawling litigation over the acne medication Accutane."
"In 2007, New Jersey judge Carol Higbee handed an edge to plaintiffs lawyers at ...
April 1, 2015, Life Sciences Essentials Webinar Series
March 11, 2015, Law360
February 23, 2015, Covington E-Alert
February 13, 2015, Covington E-Alert
February 4, 2015, Covington E-Alert
January 27, 2015, Scrip Regulatory Affairs
January 26, 2015, Covington E-Alert
January 23, 2015, Covington E-Alert
January 20, 2015, InsideMedicalDevices Blog
January 12, 2015, InsideMedicalDevices Blog
2015, Webinar, 24th Annual EU Pharmaceutical Forum
December 8, 2014
WASHINGTON, DC, December 8, 2014- The Food and Drug Law Institute (FDLI) has named Covington & Burling partner Peter Safir a recipient of its 2014 Distinguished Service and Leadership Award. The annual awards honor four outstanding leaders in the food and drug law community.Mr. Safir, co-chair of Covington’s food and drug practice group, has been practicing in ...
December 4, 2014, Covington E-Alert
December 1, 2014, Covington E-Alert
December 2014, eHealth Law & Policy
November 14, 2014, Law360
November 12, 2014, Covington E-Alert
November 6, 2014, Life Sciences Essentials Series Webinar
November 4, 2014, Covington E-Alert
November 3, 2014, Law360
October 16, 2014, Life Sciences Essentials Series Webinar
October 10, 2014, InsideMedicalDevices Blog
September 23, 2014, Covington E-Alert
September 9, 2014, Covington E-Alert
August 21, 2014, Covington E-Alert
August 21, 2014, InsideMedicalDevices Blog
August 18, 2014, Covington E-Alert
August 5, 2014
LONDON, 5 August, 2014 — Covington & Burling advised Illumina on its partnership with Genomics England to provide infrastructure and expertise for a four-year project that aims to make the UK the world leader in genetic research into cancer and rare diseases, through funding research to decode 100,000 human genomes - a patient's personal DNA code. The deal is ...
July 29, 2014, Forbes
Covington's John Balzano writes on the safety issues with meat production in his blog for Forbes Asia.
"Safety issues with the meat and meat products in China are causing controversy again. Last year a group of diseased pig carcasses came floating into rivers near Shanghai, causing concern about black markets for meat spreading foodborne illnesses. This time ...
July 18, 2014, Covington E-Alert
July 17, 2014, Law360
Dan Speigel and Anne Pence co-authored this article on the use of antibiotics.
"Alarmed by the real health, economic and security risks associated with “superbugs” that are resistant to antibiotics — the lynchpins of modern medicine — President Obama has included anti-microbial resistance as a focus of his 26-nation partnership Global Health Security Agenda. He ...
July 2, 2014, Covington E-Alert
July 1, 2014, Covington E-Alert
July 1, 2014, InsideMedicalDevices Blog
June 25, 2014, Forbes
Covington's John Balzano writes on Chinese pet food regulation for Forbes.
"Long-term, all-too-frequent, and severe safety issues with pet treats and pet food coming from China have led to serious questions about the state of China’s pet food regulations. The answer to those questions may be fairly simple: China does not have a significant body of pet food ...
June 19, 2014, Covington E-Alert
June 4, 2014, Covington E-Alert
June 2, 2014, InsideMedicalDevices Blog
May 22, 2014, InsideMedicalDevices Blog
April 30, 2014, Covington E-Alert
April 28, 2014, Covington E-Alert
April 25, 2014, Covington E-Alert
April 20, 2014, Forbes
Covington's John Balzano writes about a recent announcement by the China FDA and the Ministry of Public Security that China is creating a special police unit for food and drug law violations.
April 16, 2014, Law360
April 9, 2014, Covington E-Alert
April 1, 2014, Covington E-Alert
March 2014, Pharma Recht
March 24, 2014, Forbes
John Balzano, special counsel in Covington's food and drug practice group, writes about the regulatory enforcement of illegal sales of recycled or expired food in Chinese village markets in his latest blog post for Forbes.
March 6, 2014, Covington E-Alert
March 4, 2014
WASHINGTON, DC, March 4, 2014 —The Legal Aid Society of the District of Columbia has awarded Stefanie Doebler its Klepper Prize for Volunteer Excellence, which recognizes lawyers early in their careers who have made a significant volunteer contribution to the Society. Ms. Doebler, special counsel in Covington & Burling’s health care and food and drug practice ...
March 4, 2014, Covington E-Alert
March 3, 2014, Covington E-Alert
March 2014, The Life Sciences Law Review
February 28, 2014, Covington E-Alert
February 21, 2014, Covington E-Alert
February 5, 2014, Covington E-Alert
January 29, 2014, Covington E-Alert
January 22, 2014, Covington E-Alert
January 16, 2014, Covington E-Alert
January 10, 2014, Covington E-Alert
December 31, 2013, Covington E-Alert
December 24, 2013, Covington E-Alert
December 2, 2013, Covington E-Alert
November 20, 2013, Covington E-Alert
November 15, 2013, Law360
November 12, 2013, Covington E-Alert
November 8, 2013, Covington E-Alert
November 7, 2013, Covington E-Alert
October 31, 2013, Covington E-Alert
October 22, 2013, Covington E-Alert
October 1, 2013, Covington E-Alert
NEW YORK, September 27, 2013 — Covington & Burling received six awards at the inaugural LMG Life Sciences awards on September 25, including “FDA Pharmaceutical Firm of the Year” and Richard Kingham’s induction to the Hall of Fame.
The awards, which are selected based on a survey of peers and leading companies in the life sciences industry, “recognize and honor ...
September 26, 2013, Covington E-Alert
September 25, 2013, Covington E-Alert
September 24, 2013, Covington E-Alert
September 6, 2013, Law360
August 28, 2013, Covington E-Alert
August 19, 2013, Covington E-Alert
August 16, 2013, Covington E-Alert
August 12, 2013, Covington E-Alert
August 9, 2013, Covington E-Alert
August 8, 2013, Covington E-Alert
August 2013, Journal of Medical Device Regulation
July 31, 2013, Covington E-Alert
July 30, 2013, Covington E-Alert
July 26, 2013, Covington E-Alert
July 19, 2013, Covington E-Alert
June 27, 2013, Covington E-Alert
June 25, 2013, Covington E-Alert
June 20, 2013
LONDON, 20 June, 2013 — Covington & Burling acted for Canaccord Genuity Limited (nominated adviser and joint broker) and WG Partners, a trading name of Charles Stanley & Co. Ltd (joint broker), to AIM-quoted Lombard Medical Technologies plc on its placing and subscription of ordinary shares to raise approximately £22 million before expenses.
Lombard is a ...
June 13, 2013, InsideMedicalDevices Blog
May/June 2013, Update (Reprinted with Permission of FDLI)
May 30, 2013, Covington E-Alert
May 24, 2013, Covington E-Alert
May 17, 2013, Covington E-Alert
April 26, 2013, Covington E-Alert
April 15, 2013, Covington E-Alert
April 9, 2013, Covington E-Alert
April 2013, The Life Sciences Law Review
March 28, 2013, Covington E-Alert
March 25, 2013, Covington E-Alert
March 18, 2013, Covington E-Alert
Winter/Spring 2013, The SciTech Lawyer
February 27, 2013, Covington E-Alert
February 13, 2013, Covington E-Alert
February 1, 2013, Covington E-Alert
January 28, 2013, Covington E-Alert
January 10, 2013, Covington E-Alert
January 8, 2013
WASHINGTON, DC, January 8, 2013 — E. Donald Elliott, a leading environmental and administrative lawyer and scholar, has joined Covington & Burling, strengthening the firm’s top-ranked environmental and product liability practices.
Mr. Elliott has more than 30 years of experience in environmental law, administrative law and product liability and toxic torts. He ...
January 7, 2013
NEW YORK, January 7, 2013 — Covington & Burling advised Illumina, Inc. on its announced acquisition of Verinata Health, Inc. for cash consideration of $350 million plus up to $100 million in milestone payments through 2015.
Upon completion of the acquisition, Illumina will have access to the Verinata’s verifi® prenatal test, the broadest non-invasive prenatal ...
2013, Food and Drug Law Journal (re-printed with permission of The Food and Drug Law Institute)
December 28, 2012, Covington E-Alert
December 7, 2012, Covington E-Alert
December 3, 2012, Covington E-Alert
December 2012, GxP Lifeline
November 16, 2012, Food & Drug Policy Forum (Volume 2)
WASHINGTON, DC, November 7, 2012 — Covington & Burling received 97 first-tier practice rankings in the 2013 “Best Law Firms” survey by U.S. News-Best Lawyers, placing Covington among the top 10 firms nationwide. Covington was also named “Law Firm of the Year” in both FDA Law and Corporate Compliance Law. The honor is presented to one law firm in each of the ...
November 2012, Regulatory Focus
October 31, 2012, Covington E-Alert
October/November 2012, Food Safety Magazine
October 22, 2012, Covington E-Alert
October 4, 2012, Covington E-Alert
October 3, 2012, Covington E-Alert
October 1, 2012
WASHINGTON, DC, October 1, 2012 — Covington & Burling is pleased to announce that it has elected 15 new lawyers to its partnership.
This group is comprised of diverse and talented individuals from five offices who have made their mark at the firm through exceptional work and the highest standards of client service.
“We’re delighted to welcome these 15 lawyers to ...
September 28, 2012, Covington E-Alert
September 27, 2012, Covington E-Alert
September 26, 2012, Covington E-Alert
September 17, 2012, Covington Advisory
September 13, 2012
WASHINGTON, DC, September 13, 2012 — Best Lawyers in America named seven Covington & Burling lawyers today as “2013 Lawyer of the Year” in their respective practice areas and cities. The selected lawyers received strong ratings from their peers for their “abilities, professionalism and integrity,” in the publication’s annual survey. Best Lawyers recognizes only ...
September 6, 2012
LONDON, 06 September, 2012 — Covington & Burling LLP acted as legal advisers to Meda in an agreement with Jazz Pharmaceuticals to acquire a portfolio of six pharmaceutical products for women for $95 million in cash.
The largest and most important product in the portfolio is Elestrin, a patented product with sales of almost 100 MSEK, that doctors prescribe for ...
September 2012, European Pharmaceutical Contractor
September 2012, Covington E-Alert
August 31, 2012, Covington E-Alert
August 27, 2012
WASHINGTON, DC, August 27, 2012 — Covington & Burling LLP lawyers received 196 individual mentions in 57 areas of law in the 2013 edition of The Best Lawyers in America. This annual compilation of top U.S. lawyers is based on peer-review surveys and is used as a referral guide in the legal profession.
The Covington lawyers recognized are as ...
August 16, 2012, Covington E-Alert
August 14, 2012
WASHINGTON, DC, August 14, 2012 — Covington & Burling advised AstraZeneca in its agreement with Pfizer for over-the-counter rights to sell a nonprescription version of Nexium, a medication prescribed to treat the symptoms of gastroesophageal reflux disease.
The agreement gives Pfizer rights to sell a 20mg nonprescription version of AstraZeneca's Nexium ...
August 10, 2012, Covington E-Alert
August 1, 2012, Covington E-Alert
August 2012, Journal of Medical Device Regulation
July 26, 2012, Covington E-Alert
July 16, 2012, Covington Advisory
June 29, 2012, Covington E-Alert
June 28, 2012, Covington E-Alert
June 22, 2012
NEW YORK, June 22, 2012 — Covington & Burling advised Ascom Holding AG in its acquisition of GE Healthcare’s nurse call medical device business.
The acquisition gives Ascom access to the North American nurse call market and creates opportunities to combine GE Nurse Call systems with Ascom’s existing mobility offering. With this acquisition, Ascom further ...
June 14, 2012, Covington E-Alert
June 11, 2012, Covington E-Alert
June 7, 2012, Covington Advisory
June 2012, Scrip Regulatory Affairs
May 29, 2012, Covington E-Alert
May 25, 2012, Covington E-Alert
May 24, 2012
BRUSSELS, 24 May, 2012 — Best Lawyers in Belgium has named Covington & Burling partner Peter Bogaert as the 2012 Brussels “Lawyer of the Year” in the regulatory category for his “abilities, professionalism and integrity.” Best Lawyers recognises one lawyer in each practice area and region.
Mr. Bogaert has a broad European life sciences practice. He has detailed ...
May 8, 2012, Covington E-Alert
May 7, 2012, Covington E-Alert
May 2, 2012
WASHINGTON, DC, May 2, 2012 — D.C. Super Lawyers selected 64 Covington & Burling lawyers for its 2012 list of top legal talent. Super Lawyers selects no more than five percent of the total lawyers who practice in Washington based on peer review and the publication’s independent research.
Deborah Garza and Robert Long have been named among the “Top 100” for ...
April 30, 2012, Covington E-Alert
April 24, 2012, Covington E-Alert
April 23, 2012
WASHINGTON, DC, April 23, 2012 — Covington & Burling represented AstraZeneca in its $1.26 billion acquisition of Ardea Biosciences. Under the agreement, AstraZeneca will pay $32 per share for all of the outstanding shares of Ardea.
AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and ...
March 23, 2012, Covington E-Alert
March 22, 2012, Covington E-Alert
March 12, 2012
WASHINGTON, DC, March 12, 2012 — Covington & Burling LLP has applied to open a new office in Seoul and tapped William H.Y. Park, a veteran corporate lawyer based in Korea, to help oversee the expansion.
Mr. Park will work closely with former Ambassador to the United Nations Daniel Spiegel, senior of counsel at Covington, who will be the Foreign Legal Consultant ...
March 1, 2012, Covington E-Alert
February 29, 2012, Covington E-Alert
February 13, 2012, Covington E-Alert
February 7, 2012, Covington E-Alert
January 19, 2012, Covington E-Alert
January 9, 2012, Covington E-Alert
January 3, 2012, Covington E-Alert
2012, Life Sciences Handbook
2012, PLC Life Sciences Handbook 2012
December 30, 2011, Covington E-Alert
December 23, 2011, Covington E-Alert
November 30, 2011
WASHINGTON, DC, November 30, 2011 — Washingtonian magazine has named 34 Covington & Burling attorneys as “Best Lawyers” in its December issue. The biennial list, compiled by the magazine’s editorial staff, identifies leading lawyers in the Washington area.
Of the approximately 800 “Best Lawyers” identified in the issue, Washingtonian included profiles of 31 ...
November 10, 2011
WASHINGTON, DC, November 10, 2011 — Covington & Burling represented Salix Pharmaceuticals, Ltd. in its agreement to acquire Oceana Therapeutics, Inc., a privately held global provider of gastroenterology and urology therapeutics, for $300 million in cash.
“The acquisition of Oceana expands our product portfolio of innovative products, furthers the ...
November 9, 2011, Educational Program for Chinese SFDA Officials, New Haven, CT
November 1, 2011
WASHINGTON, DC, November 1, 2011 — For the second consecutive year, U.S. News-Best Lawyers awarded Covington & Burling the most first-tier practice rankings for Washington, DC in the “Best Law Firms” survey. The 2011-12 survey also awarded the firm 82 first-tier practice rankings, placing Covington among the top 20 firms nationwide.
Additionally, U.S. ...
November 2011, Food Safety Magazine
November 2011, Journal of Medical Device Regulation
October 24, 2011, Covington E-Alert
October 5, 2011
WASHINGTON, DC, October 5, 2011 — Best Lawyers named eight Covington & Burling lawyers as the “2012 Lawyer of the Year” in their respective practice areas and cities. According to Best Lawyers, the selected lawyers have received particularly strong ratings in the Best Lawyers' survey by earning a high level of respect among their peers for their “abilities, ...
October 3, 2011
WASHINGTON, DC, October 3, 2011 — Covington & Burling LLP announced today that 10 of its lawyers have been elected to the firm’s partnership effective October 1. This group is comprised of diverse and talented individuals who have made their mark at Covington through exceptional work and the highest standards of client service. “We’re delighted to welcome these ...
October 2011, Food Manufacturing
September 7, 2011
WASHINGTON, DC, September 7, 2011 — Covington & Burling LLP lawyers received 184 individual mentions in 56 areas of law in the 2012 edition of The Best Lawyers in America. This annual compilation of top US lawyers is based on peer-review surveys and is used as a referral guide in the legal profession.
The Covington lawyers recognized are as follows: ...
September 1, 2011, Covington E-Alert
August 15, 2011
WASHINGTON, DC, August 15, 2011 — Covington & Burling LLP is pleased to announce that Ellen Flannery has been appointed to the American Bar Association Standing Committee on the Federal Judiciary.
Ms. Flannery is co-chair of the firm’s food and drug law practice group. She will serve a three-year term as the Federal Circuit member of the committee. At the ...
August 4, 2011, Covington E-Alert
July 22, 2011
NEW YORK, July 22, 2011 — Bristol-Myers Squibb Company and Amira Pharmaceuticals, Inc., have reported that the companies have signed a definitive agreement under which Bristol-Myers Squibb will acquire privately held Amira Pharmaceuticals. Covington & Burling LLP represented Bristol-Myers Squibb in the transaction.
Under the terms of the agreement, ...
July 6, 2011, Covington E-Alert
June 22, 2011, Covington E-Alert
June 13, 2011, Covington E-Alert
June 10, 2011
WASHINGTON, DC, June 10, 2011 — Covington & Burling LLP received 123 individual mentions and 45 practice mentions in Chambers USA 2011. The guidebook, which ranks lawyers by state and national practice area, is designed to identify the most skilled legal practitioners based on the qualities most valued by clients.
Here are the Covington lawyers and practices ...
May 25, 2011, Covington E-Alert
May 5, 2011
BEIJING, May 5, 2011 — Covington & Burling LLP is pleased to announce that Shaoyu Chen has joined the firm as managing director of the firm’s China food and drug practice.
Mr. Chen’s experience in food and drug law includes serving as assistant chief counsel in the U.S. Food and Drug Administration’s Office of Chief Counsel, as senior counsel at ...
April 29, 2011, Covington E-Alert
April 15, 2011, Covington E-Alert
April 6, 2011, Covington E-Alert
April 4, 2011, Covington E-Alert
March 9, 2011, Covington E-Alert
February 22, 2011
NEW YORK, February 22, 2011 — Forest Laboratories, Inc. (NYSE: FRX) and Clinical Data, Inc. (NASDAQ: CLDA) announced today that they have entered into a merger agreement pursuant to which Forest will acquire Clinical Data, a specialty pharmaceutical company focused on the development of first-in-class and best-in-category therapeutics. Covington & Burling LLP ...
February 2, 2011, Covington E-Alert
January 25, 2011, Covington E-Alert
NEW YORK, January 6, 2011 — Charlesbank Capital Partners has announced that it has acquired Peacock Engineering Company, LLC, a leading provider of outsourced food packaging and supply chain management services to many of the nation’s largest branded consumer products companies, from Behrman Capital. The terms of the transaction, which closed on December 21, ...
January 3, 2011, Covington E-Alert
2011, Life Sciences Handbook 2011
2011, Life Sciences Handbook
December 22, 2010, Covington E-Alert
December 14, 2010, Covington E-Alert
December 13, 2010, Covington E-Alert
December 9, 2010, Covington E-Alert
December 2010, Covington E-Alert
November 10, 2010, Covington E-Alert
November 4, 2010, Covington E-Alert
November 2010, Journal of Medical Device Regulation
October 29, 2010, Covington E-Alert
October 25, 2010
NEW YORK, October 25, 2010 — Kadmon Pharmaceuticals announced today that it has acquired Three Rivers Pharmaceuticals, a privately held specialty pharmaceuticals company based in Warrendale, Pennsylvania. Three Rivers will serve as the commercial and operational cornerstone for Kadmon, a privately held biopharmaceutical company based in New York City. Terms of ...
October 25, 2010, Covington E-Alert
October 14, 2010, Covington E-Alert
October 12, 2010
NEW YORK, October 12, 2010 — King Pharmaceuticals and Pfizer announced today that they have entered into an agreement for Pfizer to acquire all of the outstanding stock and stock equivalents of King for $14.25 in cash per share, or aggregate consideration of $3.6 billion. Covington & Burling LLP advised King on the transaction.
King is a vertically integrated ...
September 23, 2010, Covington E-Alert
September 22, 2010
September 17, 2010
WASHINGTON, DC, September 17, 2010 — Covington & Burling LLP received 33 first-tier practice rankings in the 2010 “Best Law Firms” survey by U.S. News Media Group and Best Lawyers. Covington’s first-tier national rankings place it among the top 10 firms nationwide and at the top of the first-tier rankings for Washington, DC.
The inaugural rankings presented in ...
September 7, 2010, Covington E-Alert
August 25, 2010, Covington E-Alert
August 18, 2010, Covington E-Alert
August 10, 2010, Covington E-Alert
August 9, 2010, Covington E-Alert
August 6, 2010
WASHINGTON, DC, August 6, 2010 — Covington & Burling LLP received 138 individual mentions in 40 areas of law in the 2011 edition of The Best Lawyers in America. This annual compilation of top US lawyers is based on peer-review surveys and is used as a referral guide in the legal profession.
The Covington lawyers recognized are as follows:
August 3, 2010, Covington E-Alert
August 2010, Journal of Medical Device Regulation
July 6, 2010
June 25, 2010
NEW YORK, June 25, 2010 — Gilead Sciences, Inc. and CGI Pharmaceuticals, Inc. today announced the signing of a definitive agreement pursuant to which Gilead will acquire CGI. Under the terms of the agreement, Gilead will acquire CGI for up to $120 million, the majority as an upfront payment and the remaining based on clinical development progress. Covington & ...
June 21, 2010, Covington E-Alert
June 16, 2010
WASHINGTON, DC, June 16, 2010 — Covington & Burling LLP received 112 individual mentions and 44 practice mentions in Chambers USA 2010. The guidebook, which ranks lawyers by state and national practice area, is designed to identify the most skilled legal practitioners based on the qualities most valued by clients.
Here are the Covington lawyers and practices ...
June 16, 2010, Covington E-Alert
June 10, 2010, Covington E-Alert
June 3, 2010, Covington E-Alert
May 25, 2010, Covington E-Alert
May 13, 2010, Covington E-Alert
LONDON, 6 May, 2010 — Intercell AG today announced that it has signed an agreement with Cytos Biotechnology Ltd. to acquire Cytos’ platform technology for monoclonal antibody discovery. The technology is based on expression cloning of monoclonal antibodies from human B-cells and enables the identification of anti-infective antibodies to prevent and treat ...
April 29, 2010, Covington E-Alert
April 28, 2010, Covington E-Alert
April 22, 2010, Covington E-Alert
April 12, 2010, Covington E-Alert
April 5, 2010, Covington E-Alert
April 2010, Covington E-Alert
March 23, 2010, Covington E-Alert
March 10, 2010, Covington E-Alert
March 5, 2010, Covington E-Alert
March 4, 2010, Covington E-Alert
February 22, 2010
WASHINGTON, DC, February 22, 2010 — Covington & Burling LLP is pleased to announce that Timothy P. Stratford, who most recently served as Assistant U.S. Trade Representative (USTR) for China Affairs, has joined the firm as a partner. He will be resident in the firm’s Beijing office and will practice in the International Trade and Finance group. Mr. Stratford’s ...
Jan 28th, 2010, Covington E-Alert
January 15, 2010
LONDON, January 15, 2010 — Covington & Burling LLP advised Minster Pharmaceuticals plc, the AIM-quoted drug development company specialising in compounds for the treatment of neurological and psychiatric conditions, in its recommended takeover by Proximagen Neuroscience plc. The terms of the all cash offer value Minster at £4.3 million. The Covington team ...
January 12, 2010, Covington E-Alert
2009/10, PLC Life Sciences Handbook 2009/10
2009/10, Life Sciences Handbook
2010, In Vitro Diagnostics: The Complete Regulatory Guide (Chapter (8) with permission from FDLI )
December 16, 2009, Covington E-Alert
November 30, 2009, Covington E-Alert
WASHINGTON, DC, November 23, 2009 — Twenty-five Covington & Burling LLP attorneys are recognized as “Top Lawyers” in the December issue of Washingtonian magazine. The list, compiled by the magazine’s editorial staff, identifies leading lawyers in the Washington area.
Of the “Top Lawyers,” Washingtonian identified 30 as “stars of the bar.” Among them is Michael ...
November 20, 2009, Covington E-Alert
November 9, 2009, Covington E-Alert
October 30, 2009, Covington E-Alert
WASHINGTON, DC, October 1, 2009 — Covington & Burling LLP today announced that ten of its lawyers have been elected to the firm’s partnership effective today. The new partners practice in the corporate, litigation, and regulatory fields.
The ten new partners and their practices are as follows:
Marney Cheek (International) represents companies and trade ...
September 15, 2009, Covington E-Alert
September/October 2009, RAJ Devices
August 31, 2009, Covington E-Alert
August 26, 2009, Covington E-Alert
August 7, 2009
WASHINGTON, DC, August 7, 2009 — Covington & Burling LLP received 131 individual mentions in 38 areas of law in the 2010 edition of The Best Lawyers in America. This annual compilation of top US lawyers is based on peer-review surveys and is used as a referral guide in the legal profession.
The Covington lawyers recognized are as follows:
July 31, 2009, Covington E-Alert
July 27, 2009, Covington E-Alert
NEW YORK, NY, July 22, 2009 — Medarex and Bristol-Myers Squibb announced today that Bristol-Myers Squibb entered into an agreement for Bristol-Myers Squibb to acquire all of the outstanding stock and stock equivalents of Medarex for $16.00 in cash per share, or aggregate consideration of $2.4 billion. Covington & Burling LLP advised Medarex on the ...