Senator Burr Statement on Vote Against FDA User Fee Agreement Package

Today, Senator Richard Burr (R-NC), Ranking Member of the Senate Committee on Health, Education, Labor and Pensions (HELP), released the following statement after voting against the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act:

“For more than 25 years in Congress, I’ve pushed for reforms to ensure the FDA can do its critical work quickly, effectively, and with accountability. An innovative and capable FDA is absolutely essential to meeting the next generation of public health challenges we will face. But recent and systemic failures at the agency, especially the failure to respond to the urgent and devastating infant formula shortage, have raised serious concerns about the FDA’s ability to do its most basic job.

“This legislation includes changes that would help strengthen oversight and accountability at the FDA. That includes creating a new Office of Critical Foods, imposing new timelines to help bring formulas to market faster, and requiring the agency work with industry to solve problems with inspections. It also takes important steps to enhance the accelerated approval pathway, support the development of generic and biosimilar drugs, advance innovation for rare diseases, and modernize the diagnostic testing framework.

“It’s a shame, then, that my colleagues have included amendments that would kill innovation, placing the entire bill in jeopardy. Senator Murray and I worked diligently to include commonsense provisions on some of the most difficult issues facing the FDA. Unfortunately, the amendments that were added during today’s mark-up take us backwards, making it more difficult to bring life-saving products, treatments, and cures to Americans. That goes against the entire purpose of this bill. It also undermines the bipartisan framework this Committee worked months to achieve. For these reasons, I have voted against the amended bill.”

The Senate HELP Committee voted 13-9 to pass the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act to the full Senate for consideration. The Committee also passed:

• S. 958, the Maximizing Outcomes through Better Investments in Lifesaving Equipment for (MOBILE) Health Care Act;
• S. 4353, the Retirement Improvement and Savings Enhancement to Supplement Healthy Investments for the Nest Egg (RISE & SHINE) Act;
• H.R. 1193, the Cardiovascular Advances in Research and Opportunities Legacy Act; and,
• S. 4052, the Early Hearing Detection and Intervention Act of 2022.

On May 17, 2022, Senators Burr and Murray released the discussion draft of the FDASLA Act, a bipartisan user fee package to strengthen the agency’s review and approval process to ensure its ready for the next generation of products. This bill also modernizes diagnostic testing framework and updates oversight of cosmetics and dietary supplements.  

On May 27, 2022, the Senators introduced the FDASLA Act.

Senators Burr and Murray also introduced the RISE & SHINE Act on June 7, 2022.