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Peter Safir has been practicing in the food and drug field for over 25 years and is widely recognized in the pharmaceutical industry as one of the leading food and drug regulatory lawyers in the country. In recent years, Mr. Safir has worked primarily with the research-based pharmaceutical industry concentrating on marketing practices, life cycle management, and issues involving drug quality and manufacturing.
Mr. Safir has conducted numerous internal investigations for pharmaceutical and medical device companies involving fraud and abuse, advertising, and promotional practices. He has defended enforcement actions in the marketing and manufacturing areas representing both companies and corporate executives targeted by the FDA.
Mr. Safir has published and spoken widely in the area of drug regulation and has been a Professorial Lecturer in Food and Drug Law at George Washington University Law School since 1991. Mr. Safir is a graduate of Princeton University and the Yale Law School.
- Represented PhRMA in the drafting of the PhRMA Code on the relationship between PhRMA members and healthcare professionals.
- Represented Johnson & Johnson in obtaining pediatric exclusivity for Duragesic and successfully defended FDA grant in the District Court and Court of Appeals.
- Represented Pfizer in obtaining pediatric exclusivity for Diflucan and successfully defended the grant in District Court.
- Counsel to the Independent Panel of Guidant Corporation investigating implantable defibrillators.
- Counsel to numerous research based companies on FDA regulatory strategies.
Memberships and Affiliations
- Princeton University Class of 1967, Class Secretary (1992-2002)
- Princeton University Class of 1967, Vice President
- Corcoran Gallery of Art, Trustee (1992-1994)
- Corcoran College of Art and Design, Board of Overseers (1996-2002)
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 ...
Covington Represents Underwriters in Senseonics' IPO
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 ...
September 30, 2015
NEW YORK - Covington advised the underwriters in the $106.1 million initial public offering by Austrian-based Nabriva Therapeutics AG of 10,350,000 million American Depositary Shares, representing 1,035,000 shares of Nabriva’s common stock. This was the first U.S. initial public offering by an Austrian company. The ADSs are now listed on the NASDAQ Global Market ...
June 18, 2015
WASHINGTON, DC, June 18, 2015 — Covington advised Allergan plc in its acquisition of KYTHERA Biopharmaceuticals, Inc. for consideration having a fixed value of $75 per KYTHERA share, or approximately $2.1 billion, which will be paid 80 percent in cash and 20 percent in Allergan shares issued to KYTHERA shareholders. KYTHERA is a biopharmaceutical company ...
Covington Receives Top Tier Rankings from Legal 500 U.S.
June 9, 2015
WASHINGTON, DC, June 9, 2015 — The Legal 500 U.S. has ranked Covington as a top tier firm in nine practice areas and recognized 25 individual attorneys as “Leading Lawyers” in the directory’s 2015 edition. Additionally, Legal 500 recommended 36 Covington practice areas and 156 Covington lawyers. Top tier rankings include: Antitrust - Cartel Antitrust ...
Covington Represents Underwriters in Cidara IPO
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 ...
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 ...
August 18, 2014
WASHINGTON, DC, August 18, 2014 — Best Lawyers named Covington & Burling’s Stuart Eizenstat and Gregg Levy each a 2015 “Lawyer of the Year” in international trade and sports law, respectively, citing their “abilities, professionalism and integrity.” Overall, Covington lawyers received 217 individual mentions in 58 areas of law in the newly released annual survey ...
Covington Receives Top Tier Nods in Legal 500 U.S.
June 26, 2014
WASHINGTON, DC, June 26, 2014 — The Legal 500 U.S. has ranked Covington & Burling in its top tier in eight practice areas and recognized 23 individual attorneys as “Leading Lawyers” in the directory’s 2014 edition. Additionally, Legal 500 “recommended” 42 Covington practice areas and 153 Covington lawyers. The eight Covington practices given the top tier ranking ...
Covington Advises Forest Laboratories in $1.1 Billion Acquisition and $415 Million Royalty Monetization
April 27, 2014
NEW YORK, April 28, 2014 — Covington & Burling represented Forest Laboratories in a definitive agreement to acquire Furiex Pharmaceuticals, a drug development collaboration company, for up to $1.46 billion. The acquisition of Furiex expands Forest’s offerings in gastroenterology. Forest agreed to pay $95 per share in cash, or approximately $1.1 billion in the ...
Covington Advises Natrogen on Agreements with Takeda
December 20, 2013
WASHINGTON, DC, December 20, 2013 — Covington & Burling advised Natrogen Therapeutics International in its agreement with Takeda Pharmaceuticals for the exclusive license for worldwide development of Natura-alpha, a synthetic small molecule oral compound that is believed to inhibit pro-inflammatory cytokine expression, as well as an option to acquire Natrogen. ...
November 21, 2013
WASHINGTON, DC, November 21, 2013 — 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 hundreds of “Best Lawyers” identified in the issue, Washingtonian spotlights 14 leading Washington ...
11/07/2013
WASHINGTON, DC, November 7, 2013 — Salix Pharmaceuticals, Ltd., and Santarus, Inc. announced today that the companies have entered into a merger agreement where Salix will acquire all of the outstanding stock of Santarus for $32 in cash per share, for a total value of approximately $2.6 billion. Covington & Burling LLP is advising Salix on both the acquisition ...
Covington Receives Top Tier Nods in Legal 500 U.S.
June 7, 2013
WASHINGTON, DC, June 7, 2013 — The Legal 500 U.S. has ranked Covington & Burling as a top tier firm in six practice areas and recognized 21 individual attorneys as “Leading Lawyers” in the directory’s 2013 edition. Additionally, Legal 500 “recommended” 38 Covington practice areas and 148 Covington lawyers. The six Covington practices given the top tier ranking ...
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 ...
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 ...
Covington Receives Top Tier Nods in Legal 500 US
August 14, 2012
WASHINGTON, DC, August 14, 2012 — Covington & Burling LLP has received a top tier ranking in six practice areas and 18 individual attorneys are named “Leading Lawyers” in the recently released Legal 500 US 2012 edition. Additionally, Legal 500 US also “recommended” 36 Covington practice areas and 123 Covington lawyers. The six Covington practices given the top ...
Covington Lawyers Recognized by D.C. Super Lawyers
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 ...
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 ...
Eight Covington Lawyers Named ‘2012 Lawyer of the Year’
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, ...
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: ...
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 ...
Covington Lawyers Recognized by D.C. Super Lawyers
May 17, 2011
WASHINGTON, DC, May 17, 2011 — D.C. Super Lawyers selected 55 Covington & Burling lawyers for its 2011 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 has been named among the “Top 50 Women,” and Robert Long ...
February 15, 2011
WASHINGTON, DC, February 15, 2011 — For the seventh time, Practical Law Company has awarded Covington & Burling LLP its worldwide first place ranking in the Life Sciences Regulatory Super League category. PLC also singled out Covington’s Antitrust/Competition, Corporate, and Insurance practices, along with lawyers from each group, in its practice-specific ...
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 ...
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: Administrative: ...
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 3, 2010, Covington E-Alert
April 28, 2010, Covington E-Alert
March 18, 2010
WASHINGTON, DC, March 18, 2010 — Forty-five Covington & Burling LLP lawyers are recognized in the 2010 Washington, D.C. Super Lawyers. The annual list by Super Lawyers selects only five percent of the total lawyers who practice in Washington based on peer review and the publication’s independent research. In addition, partners Deborah Garza and Robert Long have ...
Jan 28th, 2010, Covington E-Alert
November 30, 2009, Covington E-Alert
Washingtonian Names 25 Covington Attorneys ‘Top Lawyers’
11/23/2009
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 ...
October 30, 2009, Covington E-Alert
August 31, 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: Administrative: ...
July 27, 2009, Covington E-Alert
June 24, 2009, Covington E-Alert
June 12, 2009
WASHINGTON, DC, June 12, 2009 — Covington & Burling LLP received 100 individual mentions and 40 practice mentions in Chambers USA 2009. 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 ...
March 30, 2009, Covington E-Alert
March 17, 2009, Covington E-Alert
February 17, 2009, Covington E-Alert
January 21, 2009, Covington E-Alert
January 15, 2009, Covington E-Alert
December 23, 2008, Covington E-Alert
December 15, 2008, Covington E-Alert
November 18, 2008, Covington E-Alert
September 29, 2008
WASHINGTON, DC, September 29, 2008 — Covington & Burling LLP received 124 individual mentions in 40 areas of law in the 2009 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: Administrative: ...
August 11, 2008, Covington E-Alert
July 11, 2008, Covington E-Alert
June 16, 2008
WASHINGTON, DC, June 16, 2008 — Covington & Burling LLP received 81 individual mentions and 45 practice mentions in the newly released 2008 Chambers USA. 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 ...
June 9, 2008, Covington E-Alert
February 19, 2008, Covington E-Alert
February 12, 2008, Covington E-Alert
January 18, 2008, Covington E-Alert
Covington Advises Pfizer on Acquisition of CovX
12/18/2007
NEW YORK, NY, December 18, 2007 — Pfizer Inc. announced today that it has entered into an agreement to acquire CovX, a privately-held biotherapeutics company. Covington & Burling LLP advised Pfizer on the transaction. Pfizer, the world’s largest research-based biomedical and pharmaceutical company, discovers and develops innovative medicines to treat and help ...
11/30/2007
WASHINGTON, DC, November 30, 2007 — Nineteen Covington & Burling LLP attorneys are recognized as “Top Lawyers” in the December 2007 issue of Washingtonian magazine. The list, compiled by the magazine’s editorial staff based on peer recommendations, identifies leading lawyers in the Greater Washington area. Of the “Top Lawyers,” Washingtonian identified 30 as the ...
November 6, 2007, Covington E-Alert
October 2, 2007, Covington E-Alert
September 6, 2007
WASHINGTON, DC, September 6, 2007 — Covington & Burling LLP received 115 individual mentions in 38 areas of law in the 2008 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 recipients are as follows: Administrative: E. Edward Bruce and ...
September 5, 2007, Covington E-Alert
August 6, 2007, Covington E-Alert
June 18, 2007
WASHINGTON, DC, June 18, 2007 — Covington & Burling LLP received 44 practice mentions and 74 individual mentions in the newly released 2007 Chambers USA guidebook. The 2007 edition of Chambers USA attempts to identify the most skilled legal practitioners throughout the country based on the qualities most valued by clients. Covington attorneys have been ...
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
December 7, 2006, Covington E-Alert
Covington Advises Abbott Laboratories in $3.7 Billion Acquisition of Kos Pharmaceuticals, Inc.
11/06/2006
NEW YORK, NY, November 6, 2006 — Abbott Laboratories (NYSE: ABT) announced the acquisition of Kos Pharmaceuticals (NASDAQ: KOSP) through a cash tender offer of $78.00 per common share, or $3.7 billion. Covington & Burling LLP represented Abbott in the transaction. Abbott is a global, broad-based health care company devoted to the discovery, development, ...
November 6, 2006, Covington E-Alert
October 9, 2006, Covington E-Alert
Covington Represents Eisai In $205 Million Acquisition of Four Oncology-Related Products
9/13/2006
WASHINGTON, D.C., September 13, 2006 — Covington represented both Eisai Co., Ltd. and Eisai Inc. in the recent $205 million product acquisition agreement with Ligand Pharmaceuticals. Eisai obtained exclusive global rights to four products, including ONTAK®, Targretin® capsules, Targretin® 1% gel and Panretin® 0.1% gel. This acquisition will help to ...
8/28/2006, Covington E-Alert
June 5, 2006, Covington E-Alert
April 14, 2006, Covington E-Alert
January 27, 2006, Covington E-Alert
August 2004, Covington E-Alert
August 2004, Covington E-Alert
April 14, 2004, Covington E-Alert
December 11, 2003, Covington E-Alert
Drug Import Provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003
December 8, 2003, Covington Report
Hatch-Waxman Provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003
December 8, 2003, Covington Report
November 26, 2003, Covington E-Alert
- The Food and Drug Law Institute, Distinguished Service and Leadership Award (2014)
- The International Who's Who of Life Sciences Lawyers (2012)
- PLC Life Sciences, Which Lawyer? for Regulatory (2005-2012)
- Recognized in the Legal Times "Leading Lawyers" series as being a top food & drug attorney in Washington DC (2005-2006).
- Named in Best Lawyers In America for his work in FDA law (2007-2014).
- The Best Lawyers in America, Washington FDA Lawyer of the Year (2012)
- Chosen by Chambers & Partners to appear in their Chambers USA Guide as a leading Washington, DC attorney in the field of Healthcare: Pharmaceutical/Medical Products Regulatory (2006-2016) and Life Sciences: Regulatory/Compliance (2014-2016).
- Legal 500 US, "Leading Lawyer" - Healthcare: Life Sciences (2014)
- Legal 500 US, Healthcare: Life Sciences (2013-2016)
- Washington DC Super Lawyers, FDA (2012-2014)
- LMG Life Sciences, "Life Science Star" (2013)
- Washingtonian, Best Lawyers (2011, 2013)
- Named in Euromoney's Expert Guides to the World's Leading Lawyers as being a leading attorney in the healthcare field (2006).
Practices
Industries
Education
Yale Law School, J.D., 1972
Princeton University, A.B., 1967
Bar Admissions
- District of Columbia