June 11, 2021 – The Food and Drug Administration (FDA) “is really central, not only to product approvals, but to what [medical product companies] can say in terms of marketing,” according to Prevision Policy Senior Editor Kate Rawson. Rawson, who spoke June 4 at a Coalition for Healthcare Communication (CHC) webinar, “What’s Ahead for the FDA?” told attendees that the FDA has been through unprecedented challenges during the past two years, and is currently at a turning point.
Rawson highlighted the “incredible amount of work” the FDA has accomplished over the past 15 months, including the authorization of three COVID-19 vaccines and an increased focus on COVID-19 therapeutics. She commented that the agency is closing the emergency use authorization window for vaccines, which “maybe is a sign that we are leaving the emergency phase of this pandemic.” At the same time, the FDA approved 53 novel drugs/biologics in 2020 and 24 novel drugs/biologics in 2021 (as of June 2)—two more approvals than last year at the same time. (Click here to view Rawson’s slides.)
CHC Executive Director Jon Bigelow noted at the beginning of the webinar that “the FDA’s success, and the success of our industry in health marketing and communication, depends on a science-based, efficient and credible process for approving new drugs and setting clear guidelines for promotion of those drugs.”
Ensuring that success likely includes a confirmed FDA Commissioner, but so far President Joe Biden has not yet nominated anyone for the role. Many of the names circulated after the election as potential nominees – with the exception of Dr. Janet Woodcock, Acting FDA Commissioner and longtime former director of the Center for Drug Evaluation and Research — are no longer considered candidates, Rawson explained.
Currently, Woodcock is in “the unenviable position of a permanent Acting Commissioner. Her nomination is being held up by several Democratic Senators who are concerned with her role in the opioid crisis as head of the Center for Drugs,” Rawson stated, adding that her ongoing testimony before Congress in her capacity as Acting Commissioner “may be part of her long-running job interview.”
In Rawson’s view, Woodcock brings invaluable agency experience (35 years) to the table, and would bring continuity and a deep understanding of the FDA’s needs during a time of crisis. She is the one person, “certainly of anyone who is being considered, and you could argue, of anyone ever considered, who would be able to hit the ground running,” she said. However, although Woodcock is considered a likely choice, FDA Commissioners are rarely career officials, so she remains “a dark horse.”
If Woodcock is not nominated for the Commissioner position, Rawson offered a few other potential – and diverse – nominees:
- Florence Houn, a former FDA official, who worked with the agency for 14 years in senior positions related to vaccine research and review and drug evaluations;
- Leana Wen, the former Health Commissioner for the City of Baltimore and president of Planned Parenthood;
- Katherine Luzuriaga, the director of the University of Massachusetts’ Center for Clinical and Translational Science;
- Gayatri Rao, a former FDA official who was director, Office of Orphan Products Development for six years, before leaving to become a vice president at Rocket Pharmaceuticals; and
- Michelle McMurry-Heath, a former Johnson & Johnson executive who currently serves as the president and CEO of the Biotechnology Innovation Organization.
“We understand McMurry-Heath was vetted, she was offered the job, but she turned it down,” Rawson stated during the webinar, adding that her confirmation might be a longshot considering she is an industry lobbyist. In a follow-up after the webinar, Rawson shared that McMurry-Heath “is really the only other candidate in the running” other than Woodcock. “She did indeed decline the job, but has since agreed to be more deeply vetted.”
As the United States emerges from the pandemic, the agency has learned a number of lessons from its experience with COVID-19, according to Rawson. These lessons include:
- A “fungible” review staff where individuals were re-assigned where they were needed and staffers were able to work from home was effective and well-received.
- Virtual meetings worked well and may continue to be used for some sponsor meetings.
- FDA can hire even during a pandemic (although training is complicated).
- De-centralized clinical trials are the “new normal” and patients prefer virtual visits.
- Investment is needed in advanced manufacturing so there can be a faster ramp-up of vaccines for the next pandemic.
- Virtual inspections could replace some site visits.
- Shortage tracking systems are here to stay.
One of the benefits of the COVID-19 experience from an FDA perspective is that the public – and Congress – may have a better understanding of the FDA’s role in public health. This heightened awareness may lead to more funding in the appropriations process but also could lead to unrealistic expectations of what the FDA can do and how fast they can do it, Rawson suggested.
She stated that Biden’s budget request for the fiscal year 2022 FDA budget includes modest increases and that the largest increase is for data modernization efforts. Further, the Prescription Drug User Fee Act (PDUFA) VII will be coming before Congress in the lead-up to 2022. Rawson indicated that this legislation is not expected to be controversial, because many of the topics are well-known to both sides and would build on changes made during the current PDUFA cycle.
One of Biden’s new priorities, she told webinar attendees, is establishing an Advanced Research Projects Agency for Health (ARPA-H) within the National Institutes of Health. This entity would support health research projects for high-priority breakthrough products, with an initial focus on cancer, diabetes and Alzheimer’s disease.