Watchdog Group to FDA: Patients Need More Than Words On Vaccine Safety Assurance; Supports Health Expert Calls for Additional Transparency

Washington, DC  – Today, Patients Over Pharma responded to new assurances from Food and Drug Administration (FDA) Commissioner Stephen Hahn that the FDA will resist “inappropriate pressure” in their vaccine approval process. These assurances come as President Trump dials up his predictions that a vaccine will be ready “very quickly” and “before the end of the year” and as concerns grow that Trump will once again apply pressure on government agencies to produce outcomes that benefit his personal interests.

“It’s great that Commissioner Hahn knows that people need assurances that the FDA will resist pressure from President Trump to rush a vaccine through the process before it’s safe, but since we’ve heard this before only to see the FDA cave to Trump’s bullying, patients are going to need more than just words to feel confident,” said Eli Zupnick, spokesman for Patients Over Pharma. “The FDA should listen to the health experts calling for additional transparency and rigor in the approval process and Congress should mandate strict transparency and reporting requirements so that patients and families can know that any vaccine approval will be based on science and data, not Trump’s personal interests.”

Commissioner Hahn claimed that the FDA never bowed to inappropriate pressure: 

“I have been asked repeatedly whether there has been any inappropriate pressure on the FDA to make decisions that are not based on good data and good science. I have repeatedly said that all FDA decisions have been, and will continue to be, based solely on good science and data. The public can count on that commitment.”

But we know that that’s simply not the case: 

Washington Post: “FDA’s hydroxychloroquine reversal raises even bigger questions about Trump’s role in pushing for the drug.” “And now, in its most significant walk-back to date, it has pulled that emergency use authorization (EUA) altogether. The decision Monday by the FDA now lends credibility to persistent suspicions that all of this was politicized from the beginning.”

Background on the Trump Administration’s history of applying pressure to health agencies 

Trump Administration Pressured Health Officials Into Clearing Unproven And Potentially Dangerous Hydroxychloroquine

July 2020: Trump tweeted directly at CDC Commissioner Hahn calling on him to “act now” on hydroxychloroquine:  “The highly respected Henry Ford Health System just reported, based on a large sampling, that HYDROXYCHLOROQUINE cut the death rate in certain sick patients very significantly. The Dems disparaged it for political reasons (me!). Disgraceful. Act now @US_FDA @TuckerCarlson @FoxNews.” [Twitter – President Trump, 7/6/20]

Headline: NBC News: “Hydroxychloroquine for COVID-19: Scientists say it’s time to stop promoting the drug.” [NBC News, 7/30/20]

June 2020: FDA Reversed Emergency Use Authorization For Hydroxychloroquine. “And now, in its most significant walk-back to date, it has pulled that emergency use authorization (EUA) altogether. The decision Monday by the FDA now lends credibility to persistent suspicions that all of this was politicized from the beginning. In its decision, the FDA said, “It is no longer reasonable to believe that oral formulations of [hydroxychloroquine] and [chloroquine] may be effective in treating COVID-19, nor is it reasonable to believe that the known and potential benefits of these products outweigh their known and potential risks.’”

Headline: Washington Post: “FDA’s hydroxychloroquine reversal raises even bigger questions about Trump’s role in pushing for the drug.” [Washington Post, 6/15/20]

Headline: New York Times: “A Mad Scramble to Stock Millions of Malaria Pills, Likely for Nothing.” [New York Times, 6/16/20]

April 2020: Director Of Key Federal Health Agency Forced Out After Resisting Political Pressure To Direct Funding To Hydroxychloroquine. “The official who led the federal agency involved in developing a coronavirus vaccine said on Wednesday that he was removed from his post after he pressed for rigorous vetting of hydroxychloroquine, an anti-malaria drug embraced by President Trump as a coronavirus treatment, and that the administration had put “politics and cronyism ahead of science.” . . . “I believe this transfer was in response to my insistence that the government invest the billions of dollars allocated by Congress to address the Covid-19 pandemic into safe and scientifically vetted solutions, and not in drugs, vaccines and other technologies that lack scientific merit,” he said in his statement. “I am speaking out because to combat this deadly virus, science — not politics or cronyism — has to lead the way.’” [New York Times, 4/22/20]

Headline: New York Times: “Health Dept. Official Says Doubts on Hydroxychloroquine Led to His Ouster.” [New York Times, 4/22/20]

FDA Granted Orphan Drug Status To Gilead’s Coronavirus Treatment Remdesivir

FDA Initially Granted Orphan Drug Status For Coronavirus Treatment Drug Remdesivir. “The Food and Drug Administration gave an experimental medicine called remdesivir to treat COVID-19 what’s called orphan drug status on Monday. To qualify for an orphan designation, drug companies must show that their product will treat a population of fewer than 200,000 patients or that it would be unprofitable.” [NPR, 3/24/20]

Orphan Drug Status Intended For Medicines Treating Conditions Afflicting Fewer Than 200,000 People; Afforded Companies Government Incentives Including Exclusive Rights To Distribution. “”Orphan” drug status is a designation for medicines that treat conditions that would otherwise be unprofitable for companies to invest research and development resources in. The status provides certain government benefits, including exclusive rights to distribution, that ostensibly incentivize companies to address lesser-known diseases. The FDA will provide orphan status to any medication that treats a disease that afflicts fewer than 200,000 people in the United States.” [USA Today, 3/27/20]

Following Public Outcry, Gilead – Not FDA – Requested Orphan Status Rescinded. “On Wednesday, Gilead issued another statement,saying that it had withdrawn its request for orphan status for remdesivir. “Gilead is confident that it can maintain an expedited timeline in seeking regulatory review of remdesivir, without the orphan drug designation,” it read.” [USA Today, 3/27/20]

Key White House Adviser Joe Grogan Joined Administration After Years As Top Lobbyist For Gilead. “The White House official who will shape a large part of the administration’s drug price plan worked on many of the same issues as an industry lobbyist, raising questions about whether he violated President Donald Trump’s ethics rules. . . . Grogan worked as the top lobbyist for Gilead Sciences until he arrived at OMB last March, dealing with issues including how much federal health programs would pay for its medicines.” [Politico, 5/27/18]

White House Ordered Halt To NIH Study Of Coronavirus Transmission Via Bats

White House Ordered NIH To Halt Funding For Study Of Coronavirus Transmission From Bats After Project Was Linked To Wuhan Lab Subject To Unproven Conspiracy Theories About Pandemic Origin. “Top infectious disease doctor Anthony Fauci told POLITICO that the White House ordered the National Institutes of Health to pull funding for a project showing how coronaviruses spread from bats to people, POLITICO’s David Lim and Brianna Ehley report. That decision came shortly after the project, run by nonprofit EcoHealth Alliance, was linked to the Wuhan Institute of Virology — a facility that’s been subject to unproven conspiracy theories about the pandemic’s origins. — The White House immediately shifted responsibility for the cancellation, saying that while it encouraged the decision, it was HHS that made the final call. An HHS spokesperson in turn said the research grant for the project was not in compliance with the NIH’s policies.” [Politico Pulse, 6/24/20]