Regulatory Focus™ > News Articles > More Trouble for FDA's OPQ? Mylan Poaches Second Major FDA Official for Regulatory Division

More Trouble for FDA's OPQ? Mylan Poaches Second Major FDA Official for Regulatory Division

Posted 28 April 2014 | By Alexander Gaffney, RAC

For the second time in the last year, generic pharmaceutical manufacturer Mylan is poaching one of the US Food and Drug Administration's (FDA) top regulatory talents.

In April 2013, FDA announced that Deborah Autor, then deputy commissioner of the Office of Global Regulatory Operations and Policy (GO), would be leaving the agency to join Mylan as senior VP of Strategic Global Quality and Regulatory Policy. GO is one of FDA's largest divisions, with more than 4,400 staff.

Now FDA has announced a second major departure. Steve Lynn, director of FDA's Office of Manufacturing and Product Quality (OPQM), a veteran of the agency since 2007, will be leaving for Mylan to be its new vice president of global quality and compliance. Lynn's last day at the agency will be 9 May 2014, FDA said.

In addition to his duties as director of OPQM, Lynn was also team lead for operations for FDA's proposed Office of Pharmaceutical Quality (OPQ), a proposed office which will oversee drug quality throughout the product lifecycle. The office is set to assume some of OPMQ's functions and other functions now vested in the Office of Pharmaceutical Science.

Lynn's departure comes soon after the departure of other high-profile agency officials affiliated with the creation of OPQ, including Greg Geba, former director of the Office of Generic Drugs, and Keith Webber, former acting director of the Office of Pharmaceutical Science.

Replacing Lynn on an acting basis will be Tom Cosgrove, now director of the Office of Unapproved Drugs and Labeling (OUDLC) and formerly an employee in the Office of Chief Counsel at FDA. Replacing him at OUDLC on an acting basis will be Kathy Anderson, a long-time employee of that office.

The full email may be found below:


25 April 2014

Subject: Leadership Changes in the Office of Compliance

CDER Staff:

This note is to announce the departure of Steve Lynn, director of the Office of Manufacturing and Product Quality (OMPQ) in CDER's Office of Compliance (OC) and transition team lead for operations for the proposed Office of Pharmaceutical Quality (OPQ). Steve has accepted the position of vice president of global quality & compliance at Mylan Pharmaceuticals. Steve's last day at FDA will be Friday, May 9.

I want to thank Steve for serving FDA in many important roles. He has worked in the Office of Compliance since 2007, and he was promoted to OMPQ director in 2011. During his time in OC, Steve oversaw implementation of the Generic Drug User Fee Act for OMPQ and played a key role in multiple high-profile compliance actions, including the Ranbaxy and Ben Venue Labs consent decrees. In addition, Steve served on detail in the Office of Regulatory Affairs (ORA) as acting director of ORA's Office of Medical Products and Tobacco Operations.

With Steve's departure, I am pleased to announce that Tom Cosgrove will serve as acting director of OMPQ. As director of the Office of Unapproved Drugs and Labeling (OUDLC), Tom has led the OC divisions responsible for unapproved and misbranded drugs. Before coming to CDER, he worked in FDA's Office of Chief Counsel as a litigator and was an attorney at Covington & Burling in Washington, D.C.

Kathy Anderson will serve as acting director of OUDLC. She has been an integral part of OUDLC's senior management team for many years. Kathy has considerable experience with compliance issues including drug registration and listing, imports, marketed unapproved drugs, health fraud drugs, and pharmacy compounding. 

Please join me in giving Tom and Kathy our full support as they assume their new roles, and let's wish Steve the very best as he embarks on a new endeavor.

Janet Woodcock


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