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…