Trump's HHS continues to assert authority over FDA in twilight of his presidency, implementing new drug timeline rules
With less than 10 days to go before a new administration comes in, Alex Azar’s HHS is implementing key changes at the FDA that are reportedly raising alarms among current and former staffers about the agency’s independence.
Azar enacted two new policies aimed at deregulating FDA review policies for new drug approvals and medical devices, HHS announced late Monday. The first requires the agency to publish its timeline for every NDA and ANDA review on its website, while the second exempts a range of devices from premarket review entirely.
Also late Monday, after the top lawyer for the FDA resigned ahead of President-elect Joe Biden’s inauguration — normal procedure for such appointees during transition periods — HHS overruled the agency’s replacement pick, per STAT.
The moves come as Azar is set to depart HHS when Biden is inaugurated on Jan 20. It remains to be seen whether Biden’s HHS nominee Xavier Becerra, currently California’s attorney general, will keep these changes in place once he is confirmed by the Senate.
Officials at the FDA were taken aback by the actions, according to Politico Pro, saying that HHS did not give the agency any heads up about whether the moves were coming. And on top of that, FDA officials were reportedly not given an opportunity to provide input on the new policies.
Former FDA commissioner Scott Gottlieb, a former appointee of outgoing President Donald Trump, blasted the changes.
“I’ve been disappointed to see HHS infringing on FDA’s public health prerogatives in the closing days of the administration,” Gottlieb wrote on Twitter. “The way they’re pursuing these unilateral actions will have long term consequences at a time when FDA’s stature is critical to seeing us through this crisis.”
Azar justified the drug timeline policy saying that, in 2019, nearly 80% of new approvals took longer than the federally mandated 180-day review period. The drug timeline rules require the FDA to post three figures online: the date in which it receives a new drug application, the date it approves a new drug and the total days elapsed between the 180-day mark and approval.
Monday’s moves are the latest in what critics say is a series of attempts throughout the Covid-19 pandemic to cripple the FDA’s independence and bring its rulemaking more under HHS control. Career officials told Politico Pro that they’re worried about what else might be in store in the final week and a half of the Trump administration, and a senior HHS official said the department will be “unleashed.”
Last September, Azar stripped the FDA and other health agencies under his purview of their rulemaking ability and asserted all such power “is reserved to the Secretary.” And when the FDA re-wrote guidelines to strengthen Covid-19 vaccine EUAs, Azar backed Trump in the matter, who called the new rules “extremely political.”