When Stephen Hahn, M.D., was confirmed as commissioner of the FDA one year ago, vaping, described at the time by one physician as the “biggest public health crisis of the Trump administration,” was the most pressing item in his in tray.
Vaping’s status as the biggest public health crisis was short-lived. Within weeks, Hahn was issuing statements about the FDA’s response to a coronavirus that would go on to define what looks set to be one of the shorter but more dramatic tenures of a commissioner.
Criticism of Hahn peaked in August when he flanked President Donald Trump at a press conference to announce the emergency use authorization of COVID-19 convalescent plasma. At the event, Hahn said for every 100 COVID-19 patients, “35 would have been saved because of the administration of plasma.”
After strong, widespread condemnation of the comment, Hahn quickly said “the criticism is entirely justified,” explaining that he should have explained “the data show a relative risk reduction not an absolute risk reduction.”
The negative impact of the comment was increased by the context. Days earlier, Trump accused the FDA of “making it very difficult for drug companies to get people in order to test the vaccines and therapeutics.”
Amid concerns that Trump would lean on the FDA to prematurely approve a vaccine before the November election, the headline of the press release issued by the agency about the EUA hailed the authorization as “another achievement in administration’s fight against pandemic.” Then Hahn appeared at a press conference with Trump and overstated the efficacy of convalescent plasma.
Two weeks after the convalescent plasma EUA, the CEOs of all the leading Western developers of COVID-19 vaccines jointly pledged to only seek FDA approval after demonstrating safety and efficacy in phase 3. The collective industry action spared Hahn and the FDA from the intense pressure they would have been under in the event a vaccine developer filed for EUA on the basis of limited data.
Even so, Hahn faced pressure from Trump, who called the FDA “a big, old, slow turtle” over the pace of its approval of Pfizer’s COVID-19 vaccine. Hahn opted for a reassuringly slow approach to handling the application in the belief the FDA had to be seen to be taking a rigorous approach to convince a skeptical public of the safety and efficacy of the vaccines.
That the U.S. ended the year with advisory committees for two effective COVID-19 vaccines is likely partly attributable to Operation Warp Speed. While Pfizer declined government funding, choosing to strike a straight doses-for-cash deal, Moderna was a major recipient of federal money and support. It is questionable whether Moderna could have developed a vaccine at a speed that would have been unthinkable 12 months ago and prepared to make more than 500 million doses a year without help.
The pandemic overshadowed everything else at the FDA this year, but routine business continued. One question at the start of Hahn’s tenure was whether the initial rejection of Sarepta Therapeutics’ Vyondys 53 showed the FDA was taking a tougher line or whether the quick reversal of the rejection indicated the continuation of the ethos that permitted the approval of Exondys 51 and other drugs on the strength of limited data sets.
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Under Hahn, the FDA rejected BioMarin’s request for approval of a hemophilia A gene therapy and told Sarepta to use an additional potency assay, delaying the progress of its Duchenne muscular dystrophy gene therapy.
Further data points are needed to show whether the BioMarin rejection is indicative of a new stance at the FDA, a desire to set a different bar for therapies in more common diseases or of no relevance to other filings. The Sarepta delay, which CEO Doug Ingram said followed a lack of communication from the FDA, may say something else about the situation at the agency’s gene therapy group in 2020.
“That [lack of dialogue], as I understand it now, is not atypical right now in this division. Remember, this division is already very burdened with an enormous amount of cell and gene therapy, INDs and the like and a lot of work. But of course, the COVID-19, I'm quite confident, has placed additional burdens on this group,” Ingram told investors after disclosing news of the delay.
If vaccines help safely bring the pandemic under control, whoever President-elect Joe Biden selects to run the FDA may, at some point in their tenure, be able to focus more of their time on addressing routine matters such as the staffing of teams handling cell and gene therapies and less on responding to a public health crisis. Exactly what Biden will prioritize at the FDA beyond COVID-19 is unclear.