HCM Deep Dive

The Revolving Door

For decades there has been a revolving door between our regulatory agencies, and the industries they are intended to regulate. While there has been ongoing criticism of this issue, it still remains unaddressed. Rather than improving the sanctity of our agencies however, that revolving door seems to be increasingly used as time goes on.

We went back through 40 years of FDA Commissioners to take a look at notable actions or accomplishments during their time, as well as the positions they took following their time as FDA Commissioner. Of course, we want to make it clear that nothing listed here is meant to represent the entirety of their careers. Neither do we want to villainize these commissioners or ignore the major accomplishments they also achieved. This is only meant to shine a spotlight on a major problem in the regulatory systems. We must be able to highlight and discuss problematic policies and actions, otherwise how can we ever hope to improve?

Frank E. Young, 1984-1989

Dr. Frank Young served 5 years as Commissioner of the FDA, and then went on to serve as Deputy Assistant Secretary in the Department of Health and Human Services amid a wave of generic drug corruption scandals. 

Following his time as an agency official, Dr. Young joined Braeburn Pharmaceuticals as Executive Vice President, Clinical and Regulatory Affairs. 

He also served as Exec. Vice President, Clinical and Regulatory Affairs: Braeburn Pharmaceuticals- 2013-2018 and Exec. Vice President of Clinical and Regulatory Affairs: Tissue Tech- 2018-2019 (Until he died in November 2019)

David A. Kessler, 1990-1997

Kessler reduced the amount of time a new drug review took, which became a very controversial move. Beyond this, Kessler made major strides with food regulation. The use of Nutritional Labels, regulating the over inflated marketing claims made, and the attempt to push forward nutritional education were all accomplishments Kessler made. Although these efforts have since been twisted and no longer resemble the consumer protection cornerstones Kessler likely intended them to be. Kessler would still go on to criticize the direction the FDA would begin taking in the coming years.

David Kessler is actually the only FDA Commissioner in over 30 years not to accept a high paid pharmaceutical company after his time at the FDA. Kessler has remained an outspoken critic of the relationship between FDA and pharmaceutical companies. 

Jane E. Henney, 1998-2001

While at the FDA, Dr. Henney worked to ban supplements and natural products that contain lovastatin, thus handing exclusivity of cholesterol lowering compounds to pharmaceutical companies, namely, AstraZeneca. She is an outspoken advocate for the FDA becoming an independent and autonomous organization.

Board of Directors: AstraZeneca- 2001- 2011

CIGNA Corporation- 2004-2018

Cubist Pharmaceuticals- 2012-2014

AmerisourceBergen- 2018-present

Mark McClellan, 2002-2004

McClellan was the first economist to hold the position. From the FDA, he went on to serve as commissioner of the Centers for Medicare and Medicaid Services until 2006. In 2007 he was appointed chair of the Reagan-Udall Foundation for the FDA.

CIGNA- Independent Board of Directors 

Johnson & Johnson- Board of Directors

Lester Crawford, 2005-2005

Appointed by George Bush, he would only serve 2 months as Commissioner. The following year, he pleaded guilty to a conflict of interest, and false reporting of information regarding stocks he owned in companies regulated by the FDA. Which is one of the few “fail safes” in place to attempt to ensure unbiased leadership free from industry influence.

Andrew von Eschenbach, 2006-2009

Eschenbach’s pet project at the FDA, was the Critical Path Initiative, an FDA funded “third party organization” designed to transform the way drugs and medical products were developed and evaluated. However, he was also criticized for overruling staff recommendations, and being influenced by lobbying efforts. Such as the FDA fast-tracked approval of a medical device manufactured by a New Jersey based pharmaceutical company. Which was lobbied for by several New Jersey Congressman.

BioTime- Board of Directors

Viamet Pharmaceuticals- Director

Margaret Hamburg, 2009-2015

Margaret Hamburg is one of those polarizing characters. Depending on who you speak to, or what project you speak of, she is either praised or villainized.

She is known for globalizing the FDA. However, she also had a hand in the Food Safety Modernization Act, which gave the FDA new power to regulate the way food is grown, harvested, and processed.

A common criticism was that under her leadership, the FDA was pushed to rush through drug approval, even at the cost of safety. For example, in 2014, 51 new drugs were approved. Setting a record for single year approvals.

In 2016, Larry Klayman, founder of Judicial Watch, filed a lawsuit on behalf of a group of people injured by the drug Levaquin. Hamburg was named, along with Johnson & Johnson and others, and alleged that Hamburg and Renaissance Technologies conspired with J&J to suppress safety information regarding the drug. It goes on to allege that Hamburg’s husband held J&J stock and profited enormously. The suit was ultimately dismissed by a Federal Judge in Washington D.C.

Alnylam Pharmaceuticals- member of the Board

Bill & Melinda Gates Foundation- member of the Global Health Scientific Advisory

GAVI- member of the Board

Rockefeller Foundation- member of the Board

**Special Note- Hamburg has also participated as a member of the CIA’s Intelligence Science Board, is affiliated with and has spoken at the World Economic Forum. She also participated in the 2021 Munich Security Council’s Monkeypox Outbreak exercise. She has also participated on an array of Covid panels, boards, and advisory committees for Governments. 

Stephen Ostroff, 2015-2016 & 2017

Ostroff has not gone on to work for Pharma in the traditional sense that so many other Public Health regulators have. Rather, Ostroff launched his own consulting firm that offers a range of services from Lobbying, Compliance, and Strategic Consulting. Clients of his firm range from everyone and everything from Churchill Downs to Regeneron Pharmaceuticals. Among their successes they tout being responsible for the recent sweeping gun control legislation in New York State and assisting a University in New York secure $60M of taxpayer monies for a new building that will host the School of Pharmacy and Pharmaceutical Sciences.

Scott Gottlieb, 2017-2019

Originally criticized for his deep pharmaceutical ties, Gottlieb’s nomination was approved in 2017. During his short time as Commissioner of the FDA, he approved the first gene therapy product in the U.S. He also unveiled a policy to step up the FDA’s oversight of all homeopathic drugs, while also seeking to remove some which were described as “volatile and unsafe”.

Gottlieb has been forward about his ties to the pharmaceutical industry. In fact, he has stated that he was “proud” of his relationship with Pfizer, and “very confident” in his record at the FDA.

Regardless, the precedence his appointment carried cannot be understated. The revolving door between the FDA and Pharma has existed for decades, but in a far quieter manner. Gottlieb’s appointment ripped down the curtains and put the relationship on full forward display for the entire country. Setting a new standard and sending the message that you can be a pharmaceutical industry insider for years and still be appointed Commissioner of the FDA now. Rather than having to build your career first, then lead the FDA, and then be rewarded with cushy, high paid board positions.

The next chapter of Scott Gottlieb’s career will be played out in the inner sanctums of Big Pharma — forever reinforcing the FDA’s critics of the revolving door between the agency and the industry.”
-Leigh Turner, bioethicist at University of Minnesota

Scott Gottlieb’s pharmaceutical positions include:

Pfizer- Independent Member of the Board of Directors 

Illumina- Board of Directors 

Tempus Labs- Member of the Board

National Resilience Inc.- Member of the Board of Directors

Mount Sinai- Member of the Board of Trustees

Stephen Hahn, 2019-2021

Hahn presided over the reviews of the first Covid-19 Vaccines that were approved for Emergency Use. 

Flagship Pioneer (Venture Capital firm behind Moderna)- Chief Medical Officer 

Robert Califf, 2016-2017 & 2022- Present

Califf was nominated as commissioner of the FDA in 2016, stepped down from the position a year later, and would assume the position again in 2022.

Califf actually has so many pharmaceutical ties however, that he was passed over for the position once before in 2009, and even in 2022 his nomination caused bipartisan opposition with Republicans and Democrats both pointing to his close ties throughout the pharmaceutical industry.

Califf’s ties with the industry include positions at:

Head of Strategy and Policy at Verily Research and Director at Portola Pharmaceuticals.

Paid Consultant positions at:

Johnson & Johnson, Merck, Eli Lily, ProPublica, GlaxoSmithKline, AstraZeneca, Sanofi, and Janssen Pharmaceuticals.

**Special Note: Califf was also named the head of medical strategy and policy at Alphabet Inc., Google’s parent company. 

Not Unique

The revolving door between the FDA and the companies it is charged with regulating is not a unique problem. Neither is it a problem that exists within the FDA alone. Actually, on the contrary, most of our regulatory agencies now find themselves in positions where the bulk of their funding comes from the very industries they are meant to regulate. One example of this is Sonny Perdue, who was appointed Secretary of Agriculture in 2017 after spending years working in agricultural sales.

This isn’t just in our agencies either, but even the sub-committees and subsidiary boards of our regulatory agencies are increasingly bound to these industries. Even our “independent advisors” often receive payments from the industry after drugs are approved!

It leaves me with two questions I would like to ask:

How can we trust federal regulators that are beholden to the industry?

Who do the federal regulators really protect? Consumers? Or major industry?

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