- February 19, 2019
The session at a conference jointly hosted by the American University Washington College of Law and the Food and Drug Law Institute in October featured former FDA commissioners Robert Califf, Margaret Hamburg, David Kessler and Andrew von Eschenbach. Lewis Grossman, Professor of Law at the American University, questioned the former commissioners on topics ranging from the constitutional rights and transparency at FDA to whether to split the food component of FDA’s regulatory reach into a separate entity.
A heated discussion sparked by Grossman’s questioning related to whether FDA should be separated from its parent agency, the US Department of Health and Human Services (HHS).
Hamburg noted three (3) of the former Commissioners had already gone on the record saying they think FDA should an independent agency. Acknowledging certain limitations exist that would likely keep their arguments from being actualized, all four (4) agreed this would be a better fit.
There is a need for the political pressures to be minimized to allow FDA to operate separately from HHS and bridge legal practices and public health in a meaningful way, Hamburg argued. It would also enable FDA to use “time and resources in a much more efficient way,” she added.
Califf noted he was never into the “political tradeoffs” that had to be made during his time as FDA Commissioner, arguing for greater independence and additional authorities.
Califf’s comments were echoed by Eschenbach, who argued that the job of an FDA Commissioner is really about working to know, understand and help meet the needs of the industries it regulates and the patients it serves. All other influencers, including political and trade policies, should not play into FDA’s central mission, Eschenbach added.
An example of a political pressure on FDA, according to Kessler, relates to the First Amendment to the United States Constitution being “used as a weapon against the Agency over the last several decades.” To address this issue, Kessler argued work is needed to address the degree of protection on regulated medical products. Striking the right balance would allow FDA to focus on its responsibilities and commitments to the public in ensuring the safety and effectiveness of drugs and devices, he said.
In addition to making better use or the available resources and addressing the political pressures that hinder FDA’s ability to carry out its regulatory agenda, other factors the former Commissioners argued for splitting it into an independent agency include an increasingly harmonized world and the adverse impact of having to regulate its sister agencies.
REFERENCE: Regulatory Focus; 19 OCT 2018; Regulatory Focus™; News Articles; 10; Former FDA Commissioners Make the Case for an Independent Regulatory Agency