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|