With the first day of the Biden administration less than a month away, speculation on upcoming changes vis-a-vis healthcare policy and the Food and Drug Administration continues to intensify. As part of its ongoing efforts to address it, the Coalition for Healthcare Communication presented a webinar last week featuring Catalyst Healthcare Consulting’s Nancy Bradish Myers, a former special assistant and senior strategic advisor to the FDA commissioner and a former senior official with both PhRMA and BIO.
Myers said that, despite the myriad challenges posed by the pandemic, 2020 has been a year of major accomplishments at the FDA. “The Coronavirus Treatment Acceleration Program increased coordination to get treatments to patients as rapidly as possible,” she explained. “Anyone with questions on their COVID development program was getting answers within a day or so, which was a very different way of interacting with sponsors than in the past. The agency coached academics to make sure they were receiving very good applications.”
Myers praised other areas of FDA innovation, including the COVID-19 Pandemic Recovery and Preparedness Plan, which was designed to improve agency-wide communication and collaboration. She also pointed to the Accelerated COVID-19 Therapeutic Intervention and Vaccine Program, a public/private partnership that helped develop an international research strategy.
“These were very different types of innovation put in place very rapidly,” she said.
Myers noted that the FDA didn’t sit still, even as much of its attention was consumed by COVID. Through October, the FDA had approved 42 novel drugs and 558 generics.
“They were doing their work. And the FDA is still doing a ton of work, preparing advisory committees and still working on treatments,” she said.
As for what comes next, Myers said the big question is whether “we are at the end of the beginning of COVID or the beginning of the end. Many people in public health will argue we are only at the end of the beginning.”
Myers nonetheless expects to see the Biden administration focus considerable attention on the FDA. “I think they will feel like they need to reestablish confidence and the gold standard of the agency,” she explained. “At the same time, we are learning so much from COVID and the pilot programs around it that there is a real opportunity to change the way the organization runs. We can take a big leap forward in regulatory policy.”
There are other lessons to be learned from the agency’s response to COVID, Myers added.
“During COVID, things were sped up at the agency,” Myers said. “Unnecessary steps were pushed to the side and the FDA is on a very efficient path right now.”
The pandemic has also revealed some gaps: the need for more advanced manufacturing capacity, improved supply chain management and the creation of a rapid evaluation process to determine what treatments are effective. The FDA will likely consider ways to address these issues.
Also up: a return to the pre-pandemic attention paid to tobacco regulation. “With COVID, tobacco was put on a back burner,” Myers said. Along those lines, she believes that food safety and nutrition may also return to regulatory prominence.
It is common when a new administration arrives – at the FDA, in the White House or elsewhere – that certain individuals announce, in essence, that there’s a new sheriff in town. That approach could manifest itself in an uptick in enforcement actions by the FDA. In 2020 there was a plummet in inspections, in part due to COVID limiting access to facilities. On the enforcement side, however, 2020 saw an uptick, likely also related to COVID:
“When there’s a crisis, fraudsters rush into the market. The FDA had to send out a lot of cease-and-desist letters,” Myers noted.
Finally, Myers expects the FDA to make concerted efforts to communicate about COVID-19 vaccines and their effectiveness, and to address health disparities and opioid abuse.
“High stakes with the pandemic demanded that the FDA innovate in 2020. It rose and met the challenge,” Myers said. “They increased communication with sponsors and they issued guidance, and the FDA was constantly finding new solutions and communicating them. They shortened response times and increased flexibility, embraced the use of digital health tools and they cultivated local and global partnerships.”
The FDA’s 2020, in Myers’ mind was “a success, though stressful. What comes next will depend in large part on COVID and post-COVID corrections, though reestablishing the FDA’s reputation will likely be the next commissioner’s first priority.”