President Donald Trump has slammed the Food and Drug Administration, accusing the agency of trying to delay approval of coronavirus vaccines and treatments until after the presidential election.
“The deep state, or whoever, at the FDA, makes it very difficult for drug companies to get vaccines and therapeutics tested,” Trump tweeted Saturday from the White House.
Obviously, they hope to delay the response after November 3. Must focus on speed and save lives! the president continued.
Trump then tagged FDA Commissioner Stephen Hahn, who has repeatedly sworn the agency is committed to speeding up safe and effective interventions until approval, guided by science, not considerations. policies.
President Donald Trump slammed the Food and Drug Administration, accusing the agency of trying to delay approval of coronavirus vaccines
FDA Commissioner Stephen Hahn has repeatedly pledged that the agency is committed to accelerating safe and effective interventions until approval, guided by science, not policy
Scientists, public health officials and lawmakers have expressed fears that the Trump administration will press the FDA to authorize a COVID-19 vaccine ahead of the November presidential election, even though data from clinical trials do not support its widespread use.
Earlier this week, a senior FDA official who will help decide the fate of a coronavirus vaccine promised to step down if the Trump administration approves a vaccine before it is proven to be safe and effective.
Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, made the statement in response to concerns raised during a conference call late last week from a working group on vaccines.
Marks told Reuters he was under no political pressure and the FDA would be guided by science alone.
“I couldn’t just stand there and see something dangerous or ineffective that was being endured,” he said.
“You have to decide where your red line is, and that’s my red line. I would feel obligated [to resign] because in doing so, I would be indicating to the American public that there is something wrong.
He added that he would also object if someone sought political gain by delaying approval of a vaccine that was found to be effective, and that was safe.
A woman (left) has her swab sample collected by a member of the LAB24 lab team for the COVID-19 test in the parking lot of the Mexican Consulate in Miami, Fla., August 15
Michael Caputo, deputy secretary of public affairs for the Department of Health and Human Services, which oversees the FDA and NIH, said the government aims to identify a safe and effective vaccine by January 2021.
Speculation about FDA approval of a vaccine under political pressure “only undermines confidence in the public health system,” Caputo said in a statement.
“I’ve never met an FDA regulator that wouldn’t quit under inappropriate pressure, and that’s how America knows its seal of approval is the gold standard.” “
Trump’s approval ratings have fallen sharply following a pandemic that has killed more than 173,000 Americans and infected more than 5.5 million. The race to produce a vaccine has become the centerpiece of his administration’s response.
Earlier this month, Trump said a vaccine was possible ahead of the November 3 vote.
In a statement Thursday, FDA Commissioner Hahn said that under Marks’ leadership, the agency’s scientists were monitoring COVID-19 vaccine trials, “whose data will be the deciding factor for any approval from the FDA ”.
Anthony Fauci, the country’s leading infectious disease expert, has also said publicly that political considerations will not influence any decision on a coronavirus vaccine.
Large-scale clinical trials of leading vaccine candidates from Moderna, Pfizer and AstraZeneca have been launched in recent weeks.
The FDA has scheduled a meeting of its external expert advisory committee on coronavirus vaccines for October 22.
Marks said the trials recruited volunteers “quite well” and it was “possible” that data could be available for interpretation as early as October.
Otherwise, the committee could still discuss broader regulatory issues regarding a vaccine, he said.