Analysis and Commentary

Acting FDA Commissioner Woodcock’s testimony before the Senate Ag/FDA Appropriations Subcommittee was well-received and reflected a lot of goodwill on the subcommittee toward FDA.

What did Dr. Woodcock Tell the Subcommittee?

• While the agency has been under stress, morale is high, and FDA has responded to the challenges posed by COVID-19.
• The funds provided in the President’s Budget Request for FY 2022 will allow FDA to strengthen its workforce, improve regulatory structures and scientific analytical capabilities, and modernize information technology (IT) infrastructure.
• Additional funding will be used to bolster three main areas:
  • Critical Public Health Infrastructure: The President’s Budget Request includes $185 million to boost public health infrastructure including data modernization, facility maintenance, and laboratory modernization. Of that $185 million, $76 million will be put towards data modernization that will allow the agency to perform real-time analysis of products, increase access to genomic information, and promote tools like artificial intelligence.
  • Core Food and Medical Product Safety Programs: The President’s Budget Request includes $97 million, $22 million of which will be used for medical device supply chain improvement, $18 million will be spent on maternal and infant health and nutrition, and $45 million will be spent on the New Era of Smarter Food Safety.
  • Public Health Issues: The President’s Budget Request includes $61 million to address public health issues. $38 million will be spent on opioid-related issues including reversal treatments, medical devices, and satellite labs to inspect mail for illegal imports. $19 million will be provided to increase inspections of foreign plants and $4.7 million will be allocated for health equity efforts. $100 million in proposed additional user fees will support the review of tobacco products and related enforcement.

What Did Senators Say About FDA and What Questions Did They Ask?  

Chairwoman Baldwin and Ranking Member Hoeven both welcomed Dr. Woodcock and expressed support for FDA and its critical mission.

Senator Baldwin expressed interest in standards of identify requirements, particularly for milk and dairy products—a back-home-in-Wisconsin issue for her. In a similar vein, she asked about regulation of additives in animal feeds, which Dr. Woodcock said she would examine. On the medical products side, Chairwoman Baldwin asked about compliance of state boards of pharmacy with FDA’s MOU on drug compounding; streamlining domestic drug manufacturing; and addressing the opioid crisis.  

She also asked about the monies in the budget request for diversity and health equity. Dr. Woodcock replied that FDA will focus on expanding clinical trial access in underserved communities through grants, fellowships, and training.

Ranking Member Hoeven commented on the need to promote biomedical innovation while balancing safety and innovation. He focused his questions on the agency’s plans for resuming inspections and his interest in how FDA plans to prevent misleading labeling of artificial meat products. Dr. Woodcock promised to work with USDA on the latter issue.

Of the other subcommittee members who were present, Senator Moran joined Chairwoman Baldwin in expressing interest in the regulation of animal feeds and at another point asked about the potential for expedited processes for updating food standards of identity. He also discussed minimum recycled content requirements and the agency’s plans to address new food contact substances.

Senator Braun asked Dr. Woodcock about how FDA could speed up drug approvals for Alzheimer’s Disease and other degenerative diseases. Dr. Woodcock acknowledged that the science behind degenerative diseases has been slow to develop. She pointed to patient engagement tools that FDA has encouraged as a way in which the process can move faster.

Editorial Note: The Analysis and Commentary section is written by Steven Grossman, Executive Director of the Alliance for a Stronger FDA. Special thanks to Reed Diskey for sharing his meeting notes.