Removing conflicts of interest at the FDA

Congress should impose regulations and limitations on where and when the FDA’s employees find subsequent employment. Rather than a mere ban on communicating directly with the FDA for one or two years after being hired by a company seeking FDA approval, there should be a complete ban on any employment within, or consulting for such companies for a period of at least two years, whether the individual would qualify as a registered lobbyist or not. This is more in line with traditional, private sector non-compete agreements.

Furthermore, Congress should avoid approving the appointment of FDA Commissioners that come from within or are affiliated with companies that will seek approval from the FDA during that Commissioner’s tenure. Likewise, Congress should impose the same restriction on the FDA to eliminate hiring regulators, and committee members that come from within companies that are soon to be seeking approvals from the FDA.

Congress should impose strict penalties on employees that return to that same company immediately after their FDA employment is over.

Additionally, Congress should require complete transparency by the FDA. They should require that the FDA stop redacting the resumes of experts that serve on advisory committees, which make it impossible to detect conflicts of interest. For example, 92 % of the 150 resumes posted in 2016 for the members of the Center for Drug Evaluation and Research advisory committees had redactions.

Finally, all grassroots lobbying, including spending on social media campaigns needs to be disclosed and reported like all other lobbying efforts.
Only when transparency is restored, and conflicts of interests are removed will the American consumer be able to trust the FDA.