Most Ex-FDA Reviewers Work for the Regulated Industry and That’s A Good Thing

Not surprisingly, a report in BMJ last week said that most reviewers find jobs in the regulated industry after leaving FDA. The authors of the report raised conflict of interest concerns regarding the so-called “revolving door” between FDA and industry. However, a close review of the existing policies at FDA show that such concern is unfounded. FDA reviewers are one of the best trained regulatory subject-matter experts in the World. An average FDA reviewer is aware of most new products being developed in the area in which he/she works at the FDA. FDA reviewers participate in discussions with multiple sponsors at all stages of development and have the insider’s perspective on the various problems encountered by developers of products and the potential solutions. This information is invaluable to the industry and hence when they are ready to leave FDA, they are highly solicited by the industry as consultants and employees. But each FDA employees is governed by multiple codes of ethics and regulatory requirements even after they leave the FDA to avoid direct conflict of interest. An ex-FDA employee is banned for life to represent the sponsor of a product that they reviewed while working for FDA in the past. They are also banned to represent sponsors for all products being reviewed by their Division at FDA for two years after leaving FDA. Senior employees such as Division Directors, Deputy Directors and alike are further banned for one year from knowingly making any communication to or appearance before any officer or employee of FDA on behalf of any sponsor of an application. Very senior officials such as FDA Commissioners and Center Directors are not permitted to contact practically anyone in FDA on behalf of an applicant for a period of 2 years after leaving service. All FDA employees are restricted for life-time to not discuss any confidential information that they became aware of while working at FDA. Together all these rules are designed to avoid real and apparent conflicts of interest. Even with these restrictions, FDA employees can work almost immediately after leaving FDA for industry; just they cannot attend meetings with FDA on behalf of their new benefactors. These ex-FDA reviewers can provide personal perspectives on the internal workings of their former FDA departments and colleagues, which is valuable for prepping to discuss and negotiate with the respective department. Without disclosing any confidential information, an individual can use the knowhow and expertise in a given technological area to assist development of products. This benefits both the FDA and industry. While the benefits to the industry may seem obvious, FDA also benefits from better educated and trained applicants who have a better understanding of review processes. This system of people working for the government and then working for the regulated industries is prevalent is practically all departments and not just FDA. Even government agencies including FDA frequently solicit experts from industry and academia to fill their ranks with the aim of getting a similar insider’s perspective of the people they regulate. This symbiotic system leads to mutual benefit and is encouraged. And it should be.