It has been a dramatic week for mRNA vaccine-maker Moderna and the US Food and Drug Administration (FDA). On 10 February, the FDA told Moderna that it would not accept the company’s application for a new influenza vaccine – a decision that reportedly involved senior leaders overruling advice from FDA staff, although the agency denied this was the case. A week later, the FDA has reversed its decision and is accepting the drug for review.
As Chemistry World columnist Derek Lowe noted on his blog, such a refusal-to-file is relatively rare, but the message it sends to companies developing new therapies – particularly vaccines – is that the agency is no longer playing by its own rules. Moderna had apparently consulted the FDA on designs for clinical trials of its vaccine, per normal procedures, and while the agency did say it would prefer the company to also test against a high-dose flu vaccine control for older patients, it did sign off on the trial designs – only to later turn round and say they were inadequate.
Experts such as Gary Nabel, former head of the US National Institutes of Health’s Vaccine Research Center and chief scientist at Sanofi, who now runs a vaccine and cancer startup, told Stat it sets a ‘destructive precedent that will undermine the future of vaccine development and the preeminence of American research’. Similar views echoed from across industrial and academic research.
So, while the reversal is clearly good news for Moderna, the shadow of doubt and insecurity will linger. Drug regulation is a complex task, and not one that companies (generally) approach lightly, given the potential cost of even small mistakes. In return, they expect regulators to operate along consistent and transparent lines. When senior leaders can step in and – almost unilaterally – overrule procedure or ignore evidence-based decision-making, then an element of trust in the regulatory process is eroded.
That applies whether such decisions impede or promote a drug’s progress through the system, and there have been examples of both in recent years. Approvals of gene therapies for Duchenne muscular dystrophy, as well as the anti-amyloid antibodies for Alzheimer’s disease could be classified as optimistic, and certainly involved significant influence from FDA leaders at the time, for example.
The current regime’s unpredictability, combined with a clear distaste for vaccines, has the potential to inflict significant harm on future vaccine development. This extends beyond the US, since many countries with less well-developed regulatory infrastructure rely heavily on FDA decisions to inform their own approvals.
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