As the United States eagerly awaits mass rollout of COVID-19 vaccines, combating misinformation and confusion requires clear, evidence-based information from the nation’s leaders. Consistent guidance on the effectiveness of vaccines and who should be receiving them may well be the difference between a timely end to the COVID-19 crisis versus prolonged suffering.
Dr. Stephen M. Hahn, Commissioner of Food and Drugs at the U.S. FDA, made this principle clear as he briefed reporters on the steps the FDA has taken to thoroughly verify the claims of vaccine producers and medical testing manufacturers. Speaking at the January 8th Brazda Breakfast briefing, an event sponsored by APCO and hosted by our partner, The Alliance for Health Policy, Commissioner Hahn emphasized that communicating transparent standards and guidelines for the public was critical to ensuring that health care providers effectively combat COVID-19.
During his briefing Commissioner Hahn also highlighted other key actions FDA took in 2020:
- Issued multiple Emergency Use Authorizations for COVID-19 vaccines after stringent testing;
- Worked with Customs and Border Protection to crackdown on the illegal import of unapproved products claimed to treat COVID-19 as well as targeting potentially faulty shipments of sanitizing products through Operation Dirty Hands;
- Addressed food-supply issues, helping food manufacturers and distributors open and operate safely during COVID-19;
- Introduced the New Era of Smarter Food Safety blueprint report;
- Launched the 2020 Leafy Greens STEC Action Plan to prevent E. coli and other illnesses;
- Approved 28 pioneer drugs to prevent serious diseases in livestock;
- Made significant advances in labelling tobacco and regulating e-cigarette products through the Center for Tobacco Products;
- Approved 53 new drugs, many for serious and infectious diseases.
Hahn also discussed how the pandemic has impacted the FDA. He explained that the FDA’s workload has almost doubled as the agency handles its routine functions of verifying and approving medical products while also handling the challenges of emergency operations for COVID-19. In handling this workload, he praised career medical officials at the FDA who have remained dedicated to promoting evidence-based messaging and urged the incoming administration to continue designing public guidelines based on medical facts rather than political pressure or expediency. To get 340 million Americans to accept the vaccines requires that leaders be extremely transparent in the verification standards for the vaccines and to be able to point to scientific evidence to back-up the order of priority for receiving vaccinations.
He also made the important point that public officials must distinguish between unfounded criticisms of medicine and legitimate concerns about medical processes. Answering a question about fears among communities of color about the efficacy of vaccines, Dr. Hahn was frank in addressing the issue: “We should acknowledge that this is a real issue, with real, legitimate concerns among communities of color.” He called for “engagement, discussion, honest conversations that are sometimes uncomfortable, and rolling up our sleeves to have discussions about transparency with the process”.
To achieve its public health goals, Commissioner Hahn wants to see greater independence for career FDA scientists and researchers from politicized decision-making. In response to a specific question about FDA independence and whether changes should be made to enhance it, he did not shy away from the issue. “It is so important for the FDA to remain an independent body. We have worked really hard to maintain independence…We should not run away from having that conversation in the future.”
In addition to working with the FDA’s work with the Biden transition, he also pledged to work with the incoming Biden administration to continue evidence-based policies during the pandemic and urged new FDA leaders and the Biden transition team to base vaccine and treatment decisions in science and data.
Ending on an optimistic note, Dr. Hahn applauded the scientific community’s success in producing solutions to COVID-19. With dedication to scientifically rigorous standards and clear messaging to the public, he was confident that America will overcome COVID-19.
While Commissioner Hahn’s tenure is coming to a close as the Trump Administration ends on January 20th, there are a few takeaways for companies to consider. The Biden Administration and the next FDA Commissioner (the names most often mentioned in the media include in no order; Dr. David Kessler, Biden Transition advisor and former FDA Commissioner under Clinton and Bush; Dr. Josh Sharfstein, Vice Dean for Public Health Practice and Community Engagement and Professor of the Practice at the Bloomberg School of Public Health at Johns Hopkins University, former Secretary of the Maryland Department of Health and Mental Hygiene and Principal Deputy Commissioner of the U.S. Food and Drug Administration; Dr. Amy Abernathy, Principal Deputy Commissioner at the FDA and acting CIO) can be expected to build on this work and more. Some of those actions include:
- A Biden FDA can be expected, in addition to supporting an expanded vaccination campaign, to work to rebuild public and Congressional confidence in the Agency and to support a strong vaccination safety effort, both of which will be critical to a successful effort.
- A new Commissioner will also likely move to enhance the independence of the Agency including rolling back some of the very recent efforts by HHS to gain more control over the FDA including but not limited to the requirement that the HHS Secretary sign-off on new regulations and the lab test rule.
- They will continue to aggressively approve and encourage generic drugs coming to market.
- Make changes to the device approval process.
- Build on the recently released guidance on the use of Artificial Intelligence.
- Continue the regulation of tobacco products.
- Continue to recruit new staff and fill unfilled positions.
You can watch a full recording of the briefing and discussion here: https://www.c-span.org/video/?507805-1/fda-commissioner-dr-stephen-hahn-discusses-coronavirus-response