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Concerns mount among regulated industry stakeholders as White House stalls on naming FDA permanent commissioner.
A few weeks ago, it looked like the race was narrowing to name a new head for FDA, with acting commissioner Janet Woodcock the lead candidate. But with no final nomination coming from the White House, concern has mounted among regulated industry and interested stakeholders that FDA operations and stature will suffer without a permanent commissioner able to articulate new policies and gain support for innovative programs — while also fending off critics and challenges to FDA’s science-based decision-making.
The cost of delay was spelled out recently in a letter to President Joe Biden from six former FDA commissioners, who state that the absence of strong agency leadership endangers the independence and authority of this critical agency (see FDA Letter to President Biden1). The letter is signed by Robert Califf, Scott Gottlieb, Margaret Hamburg, Jane Henney, Mark McClellan and Andrew von Eschenbach. Although they don’t support any specific candidate for commissioner, they applaud Janet Woodcock for her commitment to FDA’s scientific mission and career staff, and note the benefits of the experienced leadership that she has demonstrated as acting commissioner.
In February, it appeared that Woodcock was headed for the permanent job. Her experience and efforts to spur the development and approval of innovative therapies generated support from regulated entities and the research community. A long list of patient advocates, including leading cancer and rare disease organizations, urged her nomination. That applause, however, was countered by consumer advocates who faulted Woodcock for being too ready to speed unproven therapies to market, including long-acting opioids that subsequently fueled the devastating opioid abuse epidemic.
The public health community called for former FDA official and public health advocate Joshua Sharfstein to take the lead at FDA in order to fully restore the agency’s reputation for scientific integrity. Although he had support from many Democrats in Congress, Sharfstein raised objections from others for being divisive and hostile to innovation, and his nomination has dimmed in recent weeks.
The potential damage to FDA from continued delay and uncertainty over its leadership was further emphasized by several former commissioners in a recent online Stat interview. Peggy Hamburg commented that the uncertainty over who will head the agency hurts morale and creates problems for sponsors planning R&D programs. Scott Gottlieb noted that real benefits do come with Senate confirmation related to making broader policy decisions.
The former agency leaders also agreed that FDA would be better off as an independent agency, similar to the Federal Trade Commission. Gottlieb sees little of value in FDA being part of the Department of Health and Human Services (HHS). And the group said that FDA would be a more nimble and streamlined operation if it did not have to go through additional stages of approval and sign-off from HHS, which only opens up opportunities for outside intrusions into policy making.
But as FDA still is part of HHS, there is some expectation that Senate confirmation of Xavier Becerra as secretary of this vast department this week may open the door to naming an FDA commissioner. Most other top HHS positions already have been proposed, and multiple confirmation hearings will occupy the Senate for some months ahead.
One factor delaying the Biden administration’s decision on FDA leadership has been its focus on enacting massive legislation to further fight COVID-19. Although the prime objective of the $1.9 billion American Rescue Plan is to provide support for millions of Americans and businesses facing financial hardship, the massive bill also provides billions to improve testing and disease surveillance to combat the pandemic, including $7.5 billion to promote, distribute and administer COVID vaccines (see American Rescue Plan Act of 20212).
Of note, FDA gains an extra $500 million to support the fast and efficient evaluation of vaccines, therapeutics and diagnostics to combat the pandemic and to distribute needed medical supplies. Congress also authorizes FDA to use the funds to further advance continuous manufacturing of drugs and vaccines, to bolster drug inspection programs, and to prevent drug shortages and better oversee the biopharmaceutical supply chain. And FDA is instructed to further review the large volume of medical devices initially approved for emergency use.
Less welcome for industry is a provision that alters how Medicaid calculates limits on rebates for certain drugs. In eliminating a cap on total rebate amounts, manufacturers of some drugs used heavily by Medicaid patients may face big increases in payments owed the program. However, the change is calculated to save the federal government $14 billion over 8 years to 2030, making it an attractive addition to the measure for its advocates.
Also important for access to medicines are measures to expand access to health care for Americans under revisions to the Affordable Care Act (ACA). Key provisions expand Obamacare subsidies, including free health coverage to the unemployed and erasing the need to pay back excess health care subsidies by people who underestimated their income.