Drugmakers standing in way of new FDA coronavirus vaccine guidelines, White House says

White House officials cited drugmaker opposition as the chief reason for not approving stricter guidelines from the FDA on granting an emergency use authorization for future COVID-19 vaccines, Politico reported. 

The White House's Office of Information and Regulatory Affairs, which oversees all federal rulemaking, cited drug industry objections as one of the key problems with the new guidelines, three people familiar with the matter told Politico. White House Chief of Staff Mark Meadows also conveyed similar concerns to Stephen Hahn, MD, the FDA commissioner. 

But White House officials haven't told the FDA which companies brought up concerns, and in the last week, executives from Johnson & Johnson and Merck and the drug industry trade group Biotechnology Innovation Organization expressed support for the updated guidelines, Politico reported. 

A spokesperson for the White House's Office of Management and Budget denied that the Office of Information in Regulatory Affairs raised industry concerns to the FDA, according to Politico

The White House citing drugmakers concerns as the reason for not approving the FDA's standards adds to concerns about White House interference with the FDA, experts told Politico

"In a normal procedure, the industry wouldn’t be talking at all to the White House about this. The White House again is blurring and muddying the waters on all of this," John Moore, PhD, a professor of microbiology and immunology at Weill Cornell Medical College, told Politico

The White House doesn't have to approve the guidelines, because they're not official regulations, but the FDA typically seeks the White House's approval so companies and the public will know what standards drugs are held to in order to be approved. 

Read the full article here.


Copyright © 2023 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.


Featured Whitepapers

Featured Webinars