WASHINGTON — In a tweet Saturday morning, President Donald Trump accused the Food and Drug Administration of delaying the development of coronavirus vaccines and drugs.
“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,” the president wrote. “Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives!”
There is no evidence to support Trump’s accusation, and top biotechnology executives were fast to warn that politics could not be part of the process of developing vaccines and treatments against Covid-19, and to praise the speed at which the FDA has moved.
“Politics must stay out of the conduct and interpretation of clinical trials aimed at evaluating the efficacy and safety of Covid vaccines, as public trust in the results is paramount to ending the pandemic,” John Maraganore, the chief executive of Alnylam Pharmaceuticals, told STAT.
Jeremy Levin, chairman of BIO, the biotechnology industry lobbying group, said, “Developing those critical medicines depends on the independent rigorous reviews, integrity and scientific and medical capability of the FDA. The FDA has assisted and supported the industry to become what it has, and is deeply respected in the USA and abroad.”
BIO emphasized in a statement that the industry “can only move as fast as the science allows us.”
“We are confident everyone is moving as fast as possible to ensure any vaccine or new therapy is both safe and effective for patients to use,” said Rich Masters, BIO’s executive vice president for public affairs.
Two former FDA commissioners weighed in, as well. Margaret Hamburg, who served in the post from 2009 to 2015, during the Obama administration, told STAT: “I think that it’s not surprising, to be honest, that the president is turning on the FDA. But it’s disappointing and it’s worrisome because the FDA really is a unique and vital agency, and right now it’s undertaking a series of activities that could not be more important to the health and well-being of Americans.”
Robert Califf, who was the commissioner from February 2016 until January 2017, said in a series of tweets that FDA decisions are often isolated from politics.
“One of the great things about FDA is that decisions are made by full-time civil servants without conflicts,” Califf wrote. He said one of the the FDA commissioner’s jobs is to protect the independence of these civil servants.
“It is naive to believe that politics aren’t part of the picture — both Dems and Reps,” Califf wrote. But protecting the FDA’s role is “essential for our well-being as a nation and for [the] world,” he wrote, because the FDA is the only regulatory agency anywhere that independently analyzes the raw data from clinical trials before approving products.
House Speaker Nancy Pelosi (D-Calif.) panned Trump’s comments too.
“The President’s dangerous attempt to inject himself into the scientific decisions of [the FDA] jeopardizes the health & well-being of all Americans,” Pelosi tweeted.
In fact, the development of coronavirus vaccines has proceeded at a speed that would have been unimaginable before the start of the pandemic, with clinical trials recruiting patients at a rate that is unprecedented. Proof of the efficacy of some vaccines, including one from Pfizer and BioNTech and another from Moderna, could be available in the early fall.
Both Pfizer and Moderna started their studies on July 27. Pfizer said Friday that it had already enrolled 11,000 of the 30,000 patients expected to be in the study. Moderna said it had enrolled 13,194 participants as of Friday for its 30,000-patient study, and the company has said it expects to complete enrollment in September.
When results arrive will depend not on how fast these studies recruit prospective patients, but on how quickly some of those patients contract Covid-19 and become sick and how well the vaccines work. The studies are designed so that results can be released as soon as it is clear that a vaccine is even moderately effective. This will happen faster if the vaccine works better, which is out of the FDA’s control.
The FDA, too, has worked at record speeds to prepare for an eventual coronavirus vaccine. The agency already has set a tentative date, October 22, for an expert panel to review coronavirus vaccine applications.
For therapeutics, enrolling studies has been more difficult. This is in part because of the problems with diagnostic testing in the U.S., because many studies require patients be started on the experimental drug within days of symptoms occurring. If test results take many days to be returned, the patients cannot volunteer.
The tweet — in which Trump tagged FDA Commissioner Stephen Hahn — comes at an inopportune time for the agency’s leadership, which has repeatedly insisted over the past week that it is not facing political pressure from the White House. The FDA, too, has insisted it will uphold the agency’s stringent standards for vaccine and drug approvals. Earlier this week, Peter Marks, the FDA’s top vaccine regulator, told Reuters that he would resign if asked to approve an unsafe vaccine.
The FDA did not respond to a request for comment.
Drug company executives have previously praised the speed at which the FDA has moved.
On a conference call on Aug. 5, Moderna’s chief medical officer, Tal Zaks, praised the agency for moving quickly to set up the expert panel to analyze vaccine data.
“Obviously, with the level of unmet need and more and more data emerging to substantiate the potential for benefit as we continue to accumulate safety data on the Phase III, I’m very happy to see that FDA continues to take a very proactive stance in evaluating the totality of the clinical data as it emerges,” Zaks said, according to a transcript.
In June, Eli Lilly started the first study of a drug developed specifically to combat Covid-19 — a manufactured antibody against the virus. Its chief scientific officer, Daniel Skovronsky, gave credit to the FDA in an interview with STAT.
Skovronsky said Lilly had been able to move quickly due to “flexibility and a shared sense of urgency” from the FDA. Questions from Lilly to the agency, he said, were answered quickly, often within a day.
“I’m incredibly grateful for what they’re doing alongside us to fight Covid,” Skovronsky said.
The president on Saturday also tweeted disagreement with the FDA’s decision to revoke emergency use of the malaria drug hydroxychloroquine to treat Covid-19. Although early studies indicated the drug was promising, multiple large gold-standard studies since then have failed to demonstrate that benefit.