Close the Revolving Door at the FDA

Pharmaceutical executives getting high-ranking jobs in the FDA; former FDA employees going to work for Big Pharma. This revolving door between regulator and industry is the very definition of the “fox guarding the henhouse.” This cronyism is putting Americans lives at risk and it needs to stop.

Write to Congress and tell them to close the revoling door at the FDA, and to address other instances of federal agency cronyism that undermines our health.

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Please close the revolving door at the FDA

Dear [Decision Maker],

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Pharmaceutical executives getting high-ranking jobs in the FDA; former FDA employees going to work for Big Pharma. A revolving door between regulator and industry is the very definition of the "fox guarding the henhouse." This cronyism is putting Americans lives at risk and it needs to stop.

Many FDA officials use their time at the agency as a steppingstone to more lucrative employment in the drug industry. A 2016 BMJ study found that 15 of 26 FDA employees in the hematology/oncology field who left the agency later worked or consulted for the pharmaceutical industry. In 2018, Science found that 11 of 16 FDA medical examiners who worked on 28 drug approvals and then left the agency are now employed by or consult for the companies they recently regulated.

It's not difficult to see how this could cause massive conflicts of interest. In 2009 the FDA was reviewing the AstraZeneca's drug Seroquel. The drug review panel heard from a researcher who had linked the drug to sudden cardiac death. Then-Director of Psychiatric Products, Thomas Laughren, was, according to Science, "instrumental in shepherding Seroquel and similar drugs through the review process and personally signed their FDA approvals." Seroquel was approved without any warning, but the evidence mounted and in 2011 the FDA finally updated Seroquel's label with a warning on cardiac death. Thomas Laughren later formed a consultancy to help drug makers, including AstraZeneca, navigate FDA approval.

According to the FDA's adverse event report database, 220 deaths resulted from cardiac disorders from Seroquel between 2009 and 2011, with more than 1,000 "serious events" related to cardiac disorders.

This is one example among many:
	Wellington Sun, former FDA director of the Division of Vaccines and Related Product Applications, went on to be the head of vaccine strategy and regulatory affairs at Moderna.
	Patrick Frey, a chief of staff at the FDA's Office of New Drugs, left to join Amgen as director of global regulatory policy.
	John Jenkins, an Office of New Drugs director, was appointed to the board of directors of Corbus Pharmaceuticals.
	Elaine Morefield, another FDA director, was appointed director of product quality at Aclaris Pharmaceuticals.
	Gerlad Masoudi, an FDA chief of counsel, was appointed chief legal officer at Juul Labs.
	Badrul Chowdhury, director of the Center for Drug Evaluation and Research's (CDER) Division of Pulmonary, Allergy and Rheumatology Products, left to become senior vice president of AstraZeneca.

All of these examples are just from 2018. Additionally, former head of the CDC, Julie Gerberding, actually handed this vaccine over to Merck (it had been developed by government researchers) and personally pushed and fast-tracked it--then left the CDC to become president of Merck's vaccine division.

The FDA is already compromised by its financial ties to Big Pharma through the user fee system. The revolving door further undermines the credibility of this regulatory agency.

The revolving door problem comes on top of other blatant cronyism at the FDA.

The FDA and FTC and some state's attorneys general have  recently told doctors they can't advise both their patients and the public about natural prevention and treatment for COVID-19.  If they continue to do so, they will face fines or even jail. Why? These treatments have solid research behind them. FDA drugs cannot cure Covid-19. But the FDA only seems concerned with protecting drug company monopolies.  All of this is an egregious violation of the patient/doctor relationship that will cost many lives.

Other examples of agency cronyism:  the FDA is poised to eliminate a woman's right to choose safe, natural compounded estriol as a treatment, and is creating insurmountable barriers to access homeopathic medicines.

The FDA has even threatened cherry and walnut growers with fines and jail for mentioning respected university studies on the health benefits of those simple foods. The agencies say that any reference to these benefits turns cherries and walnuts into unapproved drugs!  This nonsense has to stop. Now is the time for the American public and its political leaders to step in and stop it.

Especially during this pandemic, it is not acceptable to censor doctors or to censor others who want to share solid scientific studies with the public or to seek to ban safe, effective, and low cost treatments just because they are not profitable for drug companies. We must reform our medical system so that good science can operate within a framework of good law. We must stop fighting the commonsense observation that what we eat and how we live can affect our health just as much or more than drugs.

Lives are at stake. We are asking you, our political leaders, to step in reform a healthcare system that not only bars the use, but even the mention, of natural remedies that have not been, and never can be, put through the multi-billion dollar FDA approval process.

Sincerely,
[Your Name]
[Your Address]
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[Your Email]