Alex Miller

Associate Editor

Loyola University Chicago School of Law, JD 2026

It’s no secret that prior Food and Drug Administration (FDA) regulators, who managed drug approvals, often get comfortable, high-paying jobs at the same companies that produce those drugs and products, nor is it anything new. This is the “revolving door” of the FDA. The “revolving door” refers to the movement of employees from regulatory agencies to the private corporations they regulate. This phenomenon occurs at every level of employment from standard regulators to senior staff and high-ranking employees. In fact, every FDA commissioner since 2000 has gone on to work for a large corporation regulated by the FDA, which raises ethical concerns regarding the agency’s ability to regulate drug manufacturers without any conflict of interests or corruption. Despite the FDA’s claims that its ethics rules, in accordance with federal laws, prevent FDA regulators and employees from engaging in conflicts of interest by accepting these types of employment positions, the revolving door remains prevalent between the FDA and private pharmaceutical companies. Not only does this raise concerns about conflicts of interest and the integrity of regulatory decisions, but it also negatively impacts the country’s public health and safety because drugs and other pharmaceutical products are introduced to the market with FDA approval that otherwise should not have been due to dangerous side effects, addictive nature, or other perverse factors pertaining to the specific products.

Examples of the “Revolving Door” and its negative impacts on public safety

More recently, during the pandemic, two FDA regulators involved in oversight of COVID-19 vaccines later left the FDA and began working at Moderna. This appearance of conflict of interest contributes significantly to the growing mistrust of the FDA and the drugs and vaccines it approves. Many Americans have become skeptical of the effectiveness and safety of the approved COVID-19 vaccines, including Moderna’s vaccine, and the revolving door of FDA employees to companies like Moderna worsens these concerns and sparks further controversy.

Reports of the FDA revolving door go back decades, with the most egregious being the story of Curtis Wright and Purdue Pharma. In 1995, Wright was responsible for the FDA’s approval of OxyContin. Wright approved specific labeling language of the drug that claimed the opioid was less likely to be misused, which Purdue used to market the drug broadly. A year later, Wright left the FDA, accepting a position at Purdue Pharma, where he earned a yearly salary of nearly $400,000. Wright received his high-paying job at Purdue Pharma after approving false language about the addictive nature of OxyContin. The drug is highly accredited for worsening the opioid epidemic in America after it hit the markets in 1996 due to the rise in opioid deaths reported after its release. The drug was marketed to doctors as a low-addiction risk, leading to high-dose prescriptions, thus resulting in the deaths of thousands of people.

The biggest implication of the revolving door is that regulators have a perverse incentive to approve drugs, vaccines, and other pharmaceuticals as safe for market that otherwise may not meet FDA standards to ensure future lucrative employment. This leniency in drug and product approval puts the American People’s health and safety at risk.

What can be done?

The FDA maintains that it has robust ethics guidelines to prevent conflicts of interest, but these measures are insufficient. Furthermore, the FDA often does not keep records of their employees’ employment after leaving the agency, making it unnecessarily difficult to enforce the guidelines. Stricter safeguards are necessary to eliminate the revolving door implemented by the FDA as well as the Office of Government Ethics (OGE). Many experts recommend a longer “cooling-off period” for senior officials at the agency that prohibits a wider range of employment post-FDA, with many recommending a cool-off period as long as eight to ten years.  However, this only delays the regulator’s ability to reap the benefits offered by the private sector, not prevent it. The FDA must be more transparent in its decisions to eliminate the revolving door and its negative impacts. For example, the FDA should provide data from its studies explaining the rationale behind approvals such that the revolving door does not affect approval of harmful or ineffective products. Additionally, the FDA must implement internal agency checks that provide post-market surveillance of approved drugs and monitor the use of the revolving door.

Recently, Senator Vance of Ohio and Representative Lesko of Arizona introduced legislation aimed to eliminate the revolving door in the FDA, as well as other health agencies like the NIH and CDC. The Fixing Administrations Unethical Corrupt Influence Act (FAUCI Act) was proposed to prohibit former employees of certain health agencies, including the FDA, from serving on the board of entities involved in development and research of a drug, biological product, or device and from profiting from a drug, biological product, or device, and for other purposes. If passed, the bill would impose new ethics rules on federal employees at the FDA and other key health agencies. The proposed FAUCI Act also introduces new reforms including an eight-year prohibition on former top officials serving as board members or officers at drug or other product companies after leaving government, a ban on former federal employees who approved product applications from profiting from those products where offenders could be civilly or criminally liable, restrictions on patenting products invented during or outside the course of an individual’s federal employment, requirements for disclosure of ownership or interest in such patents within specified periods, and disclosure requirements for government officials and their spouses for any ownership stakes in patents of covered products. Although it is not perfect, enacting this legislation would be a step in the right direction for eliminating the revolving door of the FDA and other agencies and restoring public trust in these agencies.

By ending the revolving door, public trust can be restored in the FDA’s decisions, and the country’s health and safety will be better protected from harmful pharmaceutical products that otherwise should not be approved.