2021 Activities Recap: advocacy, education, and media
The Alliance for a Stronger FDA: Progress in 2021
The Alliance for a Stronger FDA unites a broad group of patient groups, consumer advocates, biomedical research advocates, health professional societies, trade groups, and industry to 1/ advocate for increased appropriated funding for FDA and 2/ educate policymakers, the media, and the public on the FDA’s mission and responsibilities.
During 2021, the Alliance succeeded as follows:
We advocated with lawmakers and other policymakers in Washington to invest in appropriations for FDA.
We educated policy makers and the public regarding FDA’s vital role in assuring our food is safe and our medical products are safe and effective.
We met with FDA leaders to understand the agency’s resource needs and help them communicate this information.
We worked with the news media to make sure they have information regarding FDA’s resource needs.
We regularly coordinated and updated the FDA stakeholder community on FDA’s resource needs and on the Alliance’s role as an advocate and educator.
Among our messages in 2021 were:
The primary beneficiary of FDA’s activities are the American people, making it critical that the public retain its leading role in the funding of the agency.
Increases in FDA’s BA appropriations have been substantial but have not kept pace with growth in FDA’s responsibilities.
The agency has an overarching need for technology and data modernization, which will require a substantial investment and generate substantial return-on-investment (ROI).
During 2021, the Alliance continued its Congressional outreach through Hill meetings, a Hill briefing, and serving as a resource for Congressional offices wanting information about FDA’s funding and programs. While funding decisions for FY 22 were not resolved by year’s end, FDA is likely to receive $200 million or more in additional BA funding if Congress passes the FY 22 Ag/FDA appropriations bill. Additionally, FDA may receive $300 million in no-year monies for infrastructure improvements if reconciliation legislation is adopted.
In May 2021, the Alliance produced a definitive analysis of the President’s FY 22 budget request for FDA and reported in detail on each subsequent step in the appropriations process. This provided a service to the Hill and the stakeholder community and was of particular value to the media. Throughout the year, important food safety and medical product publications covered the Alliance’s analysis, positions, and educational programs.
The Alliance expanded its educational outreach activities in 2021. For a number of years, the Alliance’s Friday Update newsletter has been a staple for the stakeholder community, publishing about forty-six times per year and going out to about eight hundred individuals and organizations. While frequency and circulation size remained stable, there was an increase in the breadth and number of FDA issues covered in 2021.
A notable outreach development was substantial expansion of the Alliance’s webinar series, with the Alliance hosting eleven different senior FDA officials in nine separate webinars. Each are available on an archival basis, as follows:
April 14 webinar with Dr. Janet Woodcock, Acting FDA Commissioner (transcript)
May 25 webinar with Dr. Patrizia Cavazzoni, Director of CDER (transcript).
June 16 webinar on food safety/animal health with Deputy Commissioner for Food Policy and Response Frank Yiannas, CFSAN Director Dr. Susan Mayne, CVM Director Dr. Steven Solomon (transcript)
July 14 webinar with Judy McMeekin, Associate Commissioner for Regulatory Affairs (transcript)
July 22 webinar with Dr. Jeffrey Shuren, Director of CDRH (transcript)
October 15 webinar with Dr. William Slikker, Jr, Director of the National Center for Toxicological Research (transcript)
November 15 webinar with Dr. Paul Kluetz, Deputy Director of the FDA's Oncology Center of Excellence (transcript)
December 6 webinar with Dr. Wilson Bryan, Director of the Office of Tissues and Advanced Therapies (OTAT)(CBER) (transcript)
December 14, webinar on nutrition programs with Dr. Susan Mayne, Director of the Center for Food and Applied Nutrition (transcript)
Editorial Note: The week’s Analysis and Commentary section was written by the Alliance’s Executive Director, Steven Grossman.