Welcome to the FiercePharma political roundup, where each Monday we’ll highlight developments in Washington, D.C., and elsewhere that could affect drug pricing and how drugmakers operate.
It was a contentious weekend at the FDA after attacks from President Donald Trump and his allies, who've claimed “deep state” employees within the agency are undercutting their fight against the COVID-19 pandemic.
It's worth noting up front that former agency officials defended the FDA's work, and the administration offered no evidence to support the accusation. But early Saturday, after some press reports of slow enrollment in COVID drug and vaccine trials, Trump tweeted that certain people at the FDA are “making it very difficult for drug companies to get people in order to test the vaccines and therapeutics."
The president further claimed people at the agency are “hoping to delay the answer until after November 3rd.” He tagged FDA commissioner Stephen Hahn in the post, telling the agency to focus on "speed, and saving lives!"
The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics. Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives! @SteveFDA— Donald J. Trump (@realDonaldTrump) August 22, 2020
The allegation didn’t sit well with experts and officials. Senator Patty Murray on Twitter called the president’s tweet “dangerous” and said the public “must have absolutely no doubt FDA is basing its decisions on science not the President’s conspiracy theories.” Instead of following experts, Trump is “attacking them,” Murray wrote.
Robert Califf, a former agency commissioner, tweeted that the FDA's decisions are made by “full-time civil servants without conflicts.” FDA staff “work for public health," he added, but it's "naive to believe that politics aren't part of the picture—both Dems and Reps." It's the commissioner's job to maintain independence at the agency, Califf added.
Scott Gottlieb, another former commissioner, stood by the agency’s independent authority on Sunday. He said on Face the Nation that he rejects the idea that FDA experts would “slow-walk anything or accelerate anything” based on political interests.
BIO, a trade group made up of many companies researching vaccines and drugs for COVID-19, said in a statement to the Washington Post and Stat that it's "confident everyone is moving as fast as possible to ensure any vaccine or new therapy is both safe and effective for patients to use.”
The president's tweet followed a similar allegation from White House trade adviser Peter Navarro, Axios reports. During a meeting with FDA officials last week, Navarro reportedly accused them of being “deep state” and said they “need to get on Trump Time.” Navarro has been frustrated with the agency for weeks, saying its alleged slowness in response to the pandemic has cost lives, according to Axios.
Trump's tune soon changed alongside an announcement of an FDA move. On Sunday, Trump hailed the agency's emergency use authorization for convalescent plasma as a “historic breakthrough," even as experts took issue with the limited data and Hahn's mischaracterization of the evidence.
After the emergency authorization, critics zeroed in on a statement from FDA commissioner Stephen Hahn that the drug is associated with a “35% improvement in survival," pointing out that the number is not accurate. As they noted, the supporting data came from a single-arm study, not a placebo-controlled trial.