HealthLawPolitics

Citation Needed

There are a lot of things wrong with our government. There are plenty of aspects to healthcare regulation that need to be fixed. But let’s at least focus on the right things.

Late last month, the Green Party’s presidential nominee, Dr. Jill Stein, was quoted as saying,

“In most countries, people trust their regulatory agencies and have very high rates of vaccination through voluntary programs. In the US, however, regulatory agencies are routinely packed with corporate lobbyists and CEOs. So the foxes are guarding the chicken coop as usual in the US. So who wouldn’t be skeptical?” [emphasis added]

She also tweeted,

“As a medical doctor of course I support vaccinations. I have a problem with the FDA being controlled by drug companies.” [emphasis added]

Gizmodo and others from all across the political spectrum have run articles discussing various aspects of Dr. Stein’s stance on science, and I won’t attempt to enter that debate. However I was particularly irked by the implication that the US Food & Drug Administration is somehow staffed or controlled by corporate CEOs. Personally I’ve known several junior staff at the FDA, and I’ve applied for jobs there. Anecdotal evidence from these interactions has suggested that the Agency strongly prefers to hire people without corporate experience, precisely because they want to maintain a sense of distance. However I was curious if this anecdotal observation would hold up under scrutiny.

I spent several days pouring through the FDA’s web pages, pulling the names and titles of senior staff from the Center for Biologics Evaluation & Research (CBER), the Center for Drug Evaluation & Research (CDER), and the Center for Devices & Radiological Health (CDRH). These three Centers bear the primary responsibility for reviewing, approving/clearing, and monitoring medical products in the US; for a more detailed discussion, see my previous multi-part post. In the interest of brevity, I focused on staff from offices with direct industry contact (so offices with primarily internal administrative or scientific functions were left out), and on staff at Associate Director level and above.

Next, I turned to every publically available source I could find: FDA’s own pages, Google searches, conference presentation bios, LinkedIn, etc. Not everyone had a readily locatable resume, and so I’ve simply left their ‘Previous Experience’ field blank below. What I found surprised even me. Of the 35 staff researched, only three had prior experience at medical product companies. One of those companies (Covance) is a contract research organization, and as such does not produce products for sale. Only Dr. John Sheets (Director, CDRH Office of Device Evaluation) and Dr. Robin Newman (Director, CDRH Office of Compliance) have experience in corporate C-suites. That’s less than 10% of FDA senior staff, and it’s only in the division that has absolutely zero impact on drug and vaccine regulation.

Certainly I haven’t investigated every single staffer at FDA, and the few people whom I couldn’t locate might have undisclosed corporate ties. Even if they did have such ties, that would place the number at eight out of 35. That doesn’t look very ‘packed with CEOs’ to me. I’ve got plenty of complaints about the FDA; I work in the medical device industry, and the Agency has caused many sleepless nights. But these sort of claims are unfair and unjustified.

Citation needed, Dr. Stein.

 

 

Center Position Name & Degrees Previous Non-Gov’t Experience
CBER Director Peter W. Marks, MD, PhD Medical practice at several high-profile hospitals, including Yale and Brigham & Women’s
Deputy Director Celia M. Witten, PhD, MD Medical practice at National Rehabilitation Hospital
Associate Director for Medicine Barbara D. Buch, MD Medical practice
Associate Director for Quality Assurance Sheryl L. Lard-Whiteford, PhD
Associate Director for Policy Diane Maloney, JD
Associate Director for Research Carolyn A. Wilson, PhD Entered FDA directly from school/training
Associate Director for Review Management Christopher C. Joneckis, PhD Entered FDA directly from school/training
Senior Advisor for Chemistry, Manufacturing, & Control Christopher C. Joneckis, PhD See above
CDER Director Janet Woodcock, M.D. Entered FDA directly from school/training
Deputy Director Regulatory Programs Douglas C. Throckmorton, M.D. Medical practice at MC Georgia, Augusta and Augusta VA
Deputy Director Clinical Science Robert J. Temple, M.D. Entered FDA directly from school/training
Deputy Director Science Operations Richard Moscicki, M.D. Medical practice at MGH and Harvard Medical School
Director, Office of Regulatory Policy Grail Sipes, J.D. Private law practice and financial services consulting
Director, Office of Compliance Thomas Cosgrove, J.D. Private law practice and clerk for US District Court
Director, Office of Medical Policy CAPT Denise Hinton Officer, US Air Force
Director, Office of Clinical Pharmacology Issam Zineh, Pharm.D.,M.P.H.,F.C.P.,F.C.C.P. University faculty
Director, Office of New Drugs John Jenkins, M.D. Entered FDA directly from school/training
Director, Office of Drug Evaluation I Ellis Unger, M.D. University faculty, NIH staff
Director, Office of Drug Evaluation II Curtis Rosebraugh, M.D., M.P.H.
Director, Office of Drug Evaluation III Julie Beitz, M.D.
Director, Office of Drug Evaluation IV Charles J. Ganley, M.D. Entered public service directly from school/training
Director, Office of Antimicrobial Products Edward M. Cox, M.D., M.P.H.
Director, Office of New Drug Products Sarah Pope Miksinski, Ph.D. Entered FDA directly from school/training
CDRH Center Director Jeffrey Shuren, M.D., J.D. Entered public service directly from school/training
Director, Office of Compliance Robin Newman, MSN, Ed.D. Siemens Healthcare, 2009-2016
Director, Office of Device Evaluation John Sheets, Ph.D. Various medical device companies, 1998-2014
Deputy Director for Engineering & Science Review Jonette Foy, Ph.D. Entered FDA directly from school/training
Director, ODE Division of Anesthesiology (etc.) Erin Keith, M.S. Entered FDA directly from school/training
Director, ODE Division of Cardiovascular Bram D. Zuckerman, M.D. Medical practice
Director, ODE Division of Opthalmic and ENT Malvina Eydelman, M.D. Entered FDA directly from school/training
Director, Division of Neuro and Physical Medicine Carlos Pena, Ph.D. Medical practice / university faculty
Director, Division of Orthopedic Mark Melkerson, MS Entered FDA directly from school/training
Director, Division of Surgical Binita Ashar, M.D. Medical practice
Director, Office of In Vitro Diagnostics and Radiological Health Alberto Gutierrez, Ph.D. Entered FDA directly from school/training
Director, Division of Reprodutive, Gastro-Renal, and Urological Benjamin Fisher, Ph.D. Covance, 1998-2010

 

 

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Topher

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Topher is a nerd, scientist, bioengineer, photographer, costumer, dog trainer, beer brewer, and a lot of other nouns. He has too many degrees and too many hobbies because it’s all fun and interesting, and … squirrel!

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