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Covington is the recognized leader in representing clients on FDA and related regulatory matters involving human pharmaceuticals and biotechnology products in the US, Europe, and China. Our attorneys, including several alumni of the FDA and other key regulatory bodies, advise the world’s leading biopharmaceutical manufacturers, emerging companies, and the principal industry trade associations, including PhRMA, on all aspects of human pharmaceutical and biologics regulation – from research and development to commercialization and end-of-lifecycle planning.
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 have represented clients in hearings on drug approval withdrawals, dispute resolution proceedings, rulemaking proceedings, and enforcement actions, as well as in challenges to FDA decisions regarding product exclusivities.
We regularly advise manufacturers, as well as distributors and other companies, on the legal requirements and First Amendment rights for promoting drugs, including requirements of the Prescription Drug Marketing Act (PDMA) and matters involving the FDA Office of Prescription Drug Promotion (OPDP). We have extensive experience in review of labeling and advertising claims, FTC regulatory and enforcement proceedings, Lanham Act false advertising cases, and self-regulatory advertising proceedings before the National Advertising Division (NAD) of the Council of Better Business Bureau.
Our lawyers actively advise clients on manufacturing, product quality, and FDA inspection matters. The firm has been involved in nearly all of the major FDA and Department of Justice pharmaceutical GMP enforcement actions from the landmark Warner-Lambert consent decree of 1993 forward, representing both company and individual defendants. We have a high degree of credibility on these issues with key officials from the FDA and the Office of Consumer Litigation of the Department of Justice. We also have strong working relationships with the leading GMP and QSR consultants. Our knowledge of the evolution of FDA's approach to product quality provides a strong platform from which to advise clients on technical GMP/QSR requirements, broader quality systems issues, recalls, field alerts, and FDA inspections.
Covington lawyers have been extensively involved in every aspect of the Hatch-Waxman legislation since its passage in 1984, before FDA, in the courts, and before Congress. We advise clients on strategies relating to patent listing, generic approval standards, non-patent (regulatory) exclusivity, pediatric exclusivity, settlement of patent litigation, authorized generics, and 180-day generic exclusivity. Our team has extensive experience with citizen petitions, pursuing formal and informal advocacy at FDA, and engaging in targeted litigation to maximize product lifecycles. We have represented PhRMA on all issues relating to the Hatch Waxman legislation, including in rulemakings, on amicus briefs, and with respect to legislative proposals. We were deeply involved in the rulemaking and legislative changes in 2003, and we are routinely involved—on behalf of PhRMA and individual biopharmaceutical companies—in legislative proposals in this space.
Our attorneys were also deeply engaged in the policy discussions and legislative negotiations that culminated in enactment of the Biologics Price Competition and Innovation Act of 2009 (BPCIA), on behalf of a large coalition of biotechnology innovators, many individual biopharmaceutical companies, and PhRMA. Since the law’s enactment in March 2010, we have been heavily involved in implementation on behalf of the research-based industry, coordinating advocacy in the United States with advocacy on biosimilar issues worldwide, and assisting numerous companies with development and execution of lifecycle defense strategies for key products. Our work for individual companies in this space includes advocacy at FDA on scientific, regulatory, and legal issues specific to their products (for example, on exclusivity eligibility, the scientific standards governing biosimilar applications, and policy issues connected to naming and labeling). Covington assembles integrated teams of regulatory, patent advisory, and patent litigation lawyers — all steeped in the issues presented by biosimilars — in order to craft coordinated, global patent and regulatory defense strategies.
Representation of industry stakeholders in negotiations and legislative process leading to every major amendment to the FDCA since its enactment in 1938.
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 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.
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 multinational company on regulation of online information on drugs, devices, and food products in China.
Advising distributors of prescription drugs and medical devices concerning compliance with the Food, Drug, and Cosmetic Act, FTC Act, and Lanham Act advertising standards.
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.
AstraZeneca in an FTC investigation and private antitrust class action litigation concerning settlements of Hatch-Waxman patent litigation involving Nexium.
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.
Successful defense of Pfizer in both the district court and the court of appeals on a series of claims by a relator concerning Genotropin.
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.
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.
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.
Developed for a major pharmaceutical client proposals for new potential safe harbors under the federal anti-kickback statute for potential submission to the OIG.
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.
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.
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.
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 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).
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 Merck in its $41 billion merger with Schering-Plough.
Representation of King Pharmaceuticals in its $3.6 billion acquisition by Pfizer.
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.
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 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 ...
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 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 ...
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 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 ...
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).
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 ...
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 ...
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 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 ...
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
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 ...
November 12, 2014, Covington E-Alert
March 2014, Pharma Recht
February 28, 2014, Covington E-Alert
January 29, 2014, Covington E-Alert
January 22, 2014, Covington E-Alert
January 10, 2014, Covington E-Alert
December 31, 2013, Covington E-Alert
December 2, 2013, Covington E-Alert
November 20, 2013, Covington E-Alert
November 12, 2013, Covington E-Alert
November 8, 2013, Covington E-Alert
October 1, 2013, Covington E-Alert
September 25, 2013, Covington E-Alert
August 28, 2013, Covington E-Alert
August 19, 2013, Covington E-Alert
August 12, 2013, Covington E-Alert
July 31, 2013, Covington E-Alert
June 27, 2013, Covington E-Alert
May 30, 2013, Covington E-Alert
April 15, 2013, Covington E-Alert
March 28, 2013, Covington E-Alert
March 25, 2013, Covington E-Alert
March 18, 2013, Covington E-Alert
February 27, 2013, Covington E-Alert
January 28, 2013, Covington E-Alert
December 28, 2012, Covington E-Alert
December 7, 2012, Covington E-Alert
December 3, 2012, Covington E-Alert
October 31, 2012, Covington E-Alert
September 28, 2012, Covington E-Alert
August 31, 2012, Covington E-Alert
July 26, 2012, Covington E-Alert
June 11, 2012, Covington E-Alert
May 29, 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
April 30, 2012, Covington E-Alert
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 ...
February 29, 2012, Covington E-Alert
February 7, 2012, Covington E-Alert
January 19, 2012, Covington E-Alert
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 ...
April 15, 2011, Covington E-Alert
March 9, 2011, Covington E-Alert
December 14, 2010, Covington E-Alert
December 13, 2010, Covington E-Alert
December 2010, Covington E-Alert
November 4, 2010, Covington E-Alert
September 23, 2010, Covington E-Alert
September 7, 2010, Covington E-Alert
August 9, 2010, Covington E-Alert
August 3, 2010, Covington E-Alert
June 3, 2010, Covington E-Alert
April 29, 2010, Covington E-Alert
April 28, 2010, Covington E-Alert
April 12, 2010, Covington E-Alert
April 2010, Covington E-Alert
Jan 28th, 2010, Covington E-Alert
November 30, 2009, Covington E-Alert
August 31, 2009, Covington E-Alert
August 26, 2009, Covington E-Alert
July 27, 2009, Covington E-Alert
June 29, 2009, Covington E-Alert
June 24, 2009, Covington E-Alert
April 14, 2009, Covington E-Alert
March 30, 2009, Covington E-Alert
March 25, 2009, Covington E-Alert
March 17, 2009, Covington E-Alert
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March 6, 2009, Covington E-Alert
February 23, 2009, Covington E-Alert
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February 4, 2009, Covington E-Alert
January 21, 2009, Covington E-Alert
January 16, 2009, Covington E-Alert
January 15, 2009, Covington E-Alert
December 23, 2008, Covington E-Alert
December 15, 2008, Covington E-Alert
WASHINGTON, DC, December 11, 2008 — Salix Pharmaceuticals, Ltd. announced that it has acquired rights to crofelemer from Napo Pharmaceuticals, Inc. Covington & Burling LLP represented Salix in the deal.
Crofelemer currently is being investigated in a Phase 3 study as an anti-diarrheal agent for the treatment of chronic diarrhea in people living with HIV. Salix ...
December 1, 2008, Covington E-Alert
November 18, 2008, Covington E-Alert
August 11, 2008, Covington E-Alert
July 29, 2008, Covington E-Alert
July 11, 2008, Covington E-Alert
June 9, 2008, Covington E-Alert
February 19, 2008, Covington E-Alert
February 12, 2008, Covington E-Alert
January 30, 2008, Covington E-Alert
January 18, 2008, Covington E-Alert
January 3, 2008, Covington E-Alert
November 6, 2007, Covington E-Alert
October 2, 2007, Covington E-Alert
September 4, 2007, Covington E-Alert
August 6, 2007, Covington E-Alert
June 8, 2007, Covington E-Alert
May 17, 2007, Covington E-Alert
May 3, 2007, Covington E-Alert
April 4, 2007, Covington E-Alert
February 6, 2007, Covington E-Alert
January 26, 2007, Covington E-Alert
January 19, 2007, Covington E-Alert
January 12, 2007, Covington E-Alert
December 18, 2006, Covington E-Alert
December 7, 2006, Covington E-Alert
November 6, 2006, Covington E-Alert
October 9, 2006, Covington E-Alert
September 27, 2006, Covington E-Alert
September 14, 2006, Covington E-Alert
8/21/2006, Covington E-Alert
8/28/2006, Covington E-Alert
July 20, 2006
SAN FRANCISCO, July 20, 2006 - The San Francisco office of Covington & Burling LLP advised Procter & Gamble Pharmaceuticals, Inc., a division of The Procter & Gamble Company, in its strategic alliance with ARYx Therapeutics, a private drug discovery and development company based in Fremont, CA. Under the terms of the agreement, P&G will develop and ...
June 6, 2006
LONDON, June 6, 2006 - Emergent BioSolutions, a privately-held biopharmaceutical company, has signed an agreement with sanofi pasteur, the vaccines business of the sanofi-aventis Group, to develop a critically-needed vaccine to prevent one of the world's deadliest childhood diseases, serogroup B meningitis. The Covington team that advised Emergent BioSolutions ...
June 5, 2006, Covington E-Alert
May 9, 2006, Covington E-Alert
March 3, 2006, Covington E-Alert
January 27, 2006, Covington E-Alert
January 19, 2006
WASHINGTON, D.C., January 19, 2006 - Covington & Burling represented AstraZeneca AB in its recent global licensing and research collaboration agreement with Targacept Inc. Under the terms of the agreement, which is subject to the expiration or termination of the HSR (Hart Scott Rodino) clearance period in the US, AstraZeneca will obtain the global rights for ...
September 22, 2005
WASHINGTON, D.C., September 22, 2005 - Covington & Burling lawyers Peter Barton Hutt and Peter Safir were featured as two of Washington's top eleven Leading Food & Drug Lawyers in this week's edition of Legal Times. Covington was the only firm to have two lawyers recognized.
In describing Mr. Hutt's reputation as a standout in the field, the Legal Times ...
December 2004, Covington E-Alert
October 2004, Covington E-Alert
September 17, 2004, Covington E-Alert
August 2004, Covington E-Alert
April 14, 2004, Covington E-Alert
December 11, 2003, Covington E-Alert
November 26, 2003, Covington E-Alert
March 28, 2002
March 28, 2002 - Washington, D.C.- In a historic ruling issued today, federal judge Emmet G. Sullivan overturned a federal law that prohibited District of Columbia residents from proposing, running, and voting on a ballot initiative to legalize marijuana for medical purposes. The decision resolved a First Amendment lawsuit against the federal government and the ...