Trump tweeted that the FDA was specifically out to hurt him — “obviously,” he tweeted — by delaying progress on a COVID-19 vaccine and treatment until after the presidential election.
Critics, meanwhile, accused Trump of preparing to push an unproven vaccine to win his reelection despite the health risk to Americans.
Trump appeared to accuse the FDA in his tweet of interfering with drug company recruitment of subjects for testing vaccines and therapeutic medicines in the fight against the disease caused by the coronavirus.
Research labs are responsible for finding volunteer test subjects and conducting testing but must follow health guidelines enforced by the FDA to protect people’s lives.
FDA staff people meet with researchers and inspect clinical trial study sites to “protect the rights of patients and verify the quality and integrity of the data,” according to an FDA statement.
Trump tagged FDA Commissioner Stephen Hahn in his tweet. Hahn, whom Trump named to his post last December, vowed last month in an NBC interview that the FDA “will not cut corners” to rush a risky vaccine. “We’re going to call the balls and strikes on this,” he said.
Hahn repeated that vow to doctors in a video briefing to the American Medical Association earlier this month, adding: “All of our decisions will continue to be based on good science and the same careful deliberative processes we have always used when reviewing medical products.”
Peter Marks, head of the FDA’s Center for Biologics Evaluation and Research, said earlier this month in a call with officials and pharmaceutical representatives that he would resign if the Trump administration approves a vaccine before it’s proven to be safe and effective, Reuters reported.
“You have to decide where your red line is, and that’s my red line,” he told Reuters. “I would feel obligated [to quit] because in doing so, I would indicate to the American public that there’s something wrong.” Marks said he has not yet been under any political pressure to speed approval of an unproven vaccine.
The FDA has not yet commented on Trump’s Saturday tweet attack.
House Speaker Nancy Pelosi (D-Calif.) on Saturday called Trump’s wild “deep state” accusation “very scary” and a “very dangerous” statement. “Even for him it went beyond the pale in terms of how he would jeopardize the health and well-being of the American people,” she said at a Washington news briefing.
“The FDA has a responsibility to approve drugs, judging on their safety and their efficacy — not by a declaration from the White House about speed and politicizing the FDA,” Pelosi told reporters.
Sen. Patty Murray (D-Wash.), ranking member of the Senate Health, Education, Labor and Pensions Committee, also slammed Trump’s accusation as dangerous. “The American public needs to have absolutely no doubt FDA is basing its decisions on science — not the president’s conspiracy theories,” she said in a statement to HuffPost.
Trump previously said that a COVID-19 vaccine could be ready by election day, contradicting reputable health experts. Two U.S. companies are already in phase three clinical trials for vaccines, the final stage of testing, but final results will take months.
One of the companies, Moderna, must first finish enrolling participants — possibly by the end of September, CNN reported. Volunteers are then given their first shots. They must wait 28 days before receiving a second round of shots, then wait two weeks longer to determine if the vaccine is effective.