- President Donald Trump said in a video that "no president's ever pushed" the FDA like he has as concerns mount that the administration is pressuring the agency.
- The agency on Tuesday published new guidance for vaccine manufacturers that said they need to provide at least two months of follow-up safety data after vaccinating trial participants to apply for authorization.
- That makes the authorization of a vaccine before the Nov. 3 presidential election highly unlikely.
President Donald Trump said in a video posted Wednesday that "no president's ever pushed" the Food and Drug Administration like he has as concerns mount that the administration is pressuring the agency to quickly authorize a vaccine for the coronavirus.
The FDA on Tuesday published new guidance for vaccine manufacturers that said they need to provide at least two months of follow-up safety data after vaccinating trial participants to apply for emergency use authorization. That makes the authorization of a vaccine before the Nov. 3 presidential election highly unlikely.
"We're going to have a great vaccine very, very shortly. I think we should have it before the election, but frankly the politics gets involved and that's OK. They want to play their games," Trump said in a video posted on Twitter. "The FDA has acted as quickly as they've ever acted in history. ... No president's ever pushed them like I've pushed them either, to be honest with you."
He added that "the FDA is approving things in a matter of weeks that used to take a matter of years."
After the FDA published its new guidance on emergency approvals for vaccine manufacturers, Trump tweeted that it was a "another political hit job!"
The FDA has greatly expedited the trial and authorization process of treatments and vaccines for the coronavirus by, for example, prioritizing promising treatments and streamlining clinical study design. The agency has taken such steps in order to rapidly respond to the pandemic that's already infected more than 7.5 million people in the U.S. and killed at least 211,500, according to data compiled by Johns Hopkins University.
The Trump administration's Operation Warp Speed — its Covid-19 vaccine development program — has also helped to expedite the manufacturing process by partnering with and investing in companies with promising vaccine candidates. While potential vaccines go through clinical trials, the companies, with funding from the U.S., have ramped up manufacturing of doses so that they can be quickly delivered to Americans upon authorization.
Beyond discussing vaccines, Trump also touted experimental monoclonal antibody treatments from biotech company Regeneron and pharmaceutical firm Eli Lilly. Trump was given an 8 gram dose of Regeneron's antibody cocktail early in the course of his Covid-19 infection.
"They call them therapeutic, but to me it wasn't therapeutic, it just made me better. I call that a cure," he said in the video posted Wednesday. "I have emergency use authorization all set and we got to get it signed now."
Ultimately, the companies must decide to apply for an emergency use authorization and it falls on the FDA to authorize it or not, depending on if the potential benefits outweigh the risks. But Trump insisted that "we've authorized it. I've authorized them." The White House doesn't have the authority to approve new drugs, that's the FDA's responsibility.
Shares of Regeneron rose nearly 3% after hours on Trump's comments.
Eli Lilly announced earlier Wednesday that it applied for authorization of its antibody treatment, and Regeneron announced later Wednesday evening that it, too, submitted an application.
The pace at which the FDA is moving to authorize treatments and vaccines as well as the apparent pressure from Trump has prompted concern among some former health officials, public health specialists, politicians and the public.
Trump has publicly pressured FDA Commissioner Dr. Stephen Hahn and other agency officials in the past. Early in the pandemic, Trump called for the emergency authorization of the use of anti-malaria drug hydroxychloroquine. Prescriptions for the 60-year-old medication surged 2,000% in March, but later studies found that it was actually hastening death in some patients, and the FDA pulled its emergency authorization in June.
More recently, the president publicly criticized Hahn and called for him to quickly authorize convalescent plasma for the treatment of Covid-19. Some scientists said that while the treatment appeared safe, the country would have been better served by not authorizing it and instead studying it more rigorously in large clinical trials.
Earlier this week, a House Oversight subcommittee launched an investigation into whether White House officials unduly pressured the FDA as well as the Centers for Disease Control and Prevention.
"The public wants a COVID-19 vaccine that it can trust. Assuredly, FDA and its expert staff want that too," Rep. Raja Krishnamoorthi, D-Ill., chairman of the subcommittee wrote in a letter to Hahn. "Unfortunately, President Trump has pledged to rush a vaccine into the market, and that undermines public trust in FDA's ability to ensure a safe and effective vaccine."