Rarely has the nomination of a new F.D.A. commissioner taken on the public visibility as is now happening as we await President’s Biden’s selection. Part of the reason for this heightened interest is the need for the next commissioner to restore the scientific credibility – and perhaps the morale – of an agency that is key to the future health of the nation. It’s no secret that the F.D.A. came under attack during the Trump administration particularly when it came to calls for the rapid approval for treatments for Covid-19 as well as for Covid-19 vaccines. The next commissioner will need to regain the public’s trust and show that approval decisions will be based purely on scientific merit.
The leading contenders for Biden’s nomination are Dr. Joshua Sharfstein, a vice dean at the Johns Hopkins Bloomberg School of Public Health and who held the number 2 position at the F.D.A. during the Obama administration, and Dr. Janet Woodcock, who has spent decades at the F.D.A. and who is the current acting commissioner. Each has the necessary strong credentials desired for someone nominated for this key post. However, observers of the F.D.A sense that each has his/her own vision with respect to the future direction of the F.D.A. When it comes to the approval of new drugs, the F.D.A always has to decide on the risk – benefit of the new medicine being reviewed. More often than not, these decisions are not at all straightforward and subjective views can come into play.
Woodcock is viewed as someone who has wanted the F.D.A to be a partner with the biopharmaceutical industry – not an adversary. She tends to be sympathetic to approving new drugs where there is tremendous medical need but where the efficacy is not fully demonstrated. One example occurred back in 2016 with the Duchenne muscular dystrophy drug, eteplirsen. While some experts viewed eteplirsen as not much better than a placebo, physicians and parents of children with this disease believed that the drug was beneficial for their children. Woodcock took the controversial position to approve the drug. This is not a unique action for her to take. For example, she has advocated for earlier patient access to breakthrough cancer drugs which could prove lifesaving. As a result, Woodcock has strong support from a variety of nonprofit patient advocacy groups like Friends of Cancer research.
Sharfstein is known for having a broad interest in public health – from tobacco regulation to protecting minorities during the coronavirus pandemic. He is thought of as someone who would be tougher on the biopharmaceutical industry, particularly on the need for greater transparency with respect to the interactions that the F.D.A has with companies, information that is not now readily available. He is likely sympathetic to those who believe that the F.D.A. has lowered its approval standards over the years.
Given these differences, it would be interesting to speculate how each would handle what is perhaps the biggest decision the F.D.A. will face in 2021 – the fate of Biogen’s Alzheimer’s disease drug, aducanumab. Biogen had originally dropped this drug as it appeared to have failed two large clinical trials, only to resurrect it a few months later after reanalyzing data. Initial indications were that the F.D.A. was favorably inclined to approving the New Drug Application that Biogen filed for aducanumab based on documents issued in advance of a pivotal advisory committee called to review the Biogen data. Surprisingly, the advisory committee voted 10 – 0 (one abstention) AGAINST approval. While the F.D.A. isn’t required to abide by the vote of the advisory committee, it decided to delay ruling on aducanumab. Ostensibly, the F.D.A. requested more data from Biogen before deciding the drug’s fate. The F.D.A.’s new decision date is June 7th.
It is interesting to speculate that the F.D.A. would prefer to make this decision with a permanent commissioner in place. If that is the case, then Biogen has a lot riding on who the new commissioner is. Would Woodcock look more favorably on an Alzheimer’s drug whose efficacy data is viewed skeptically by experts but addresses an area of major medical need where patients and their families are anxious for a breakthrough? Would Sharfstein set the bar high for a drug that would immediately be prescribed to thousands of patients but for which experts are not moved?
No matter what the F.D.A. decrees about aducanumab, the decision will be controversial. If approved, biopharmaceutical critics will accuse the F.D.A. of being too closely aligned with industry. If rejected, the F.D.A will be attacked by patients and advocacy groups as preventing access to a much needed new medicine. What a way to start a new F.D.A. administration.