Bipartisan user fee package ensures FDA has the resources it needs to do its work, includes new oversight of cosmetics and dietary supplements, modernizes diagnostic test regulation, reauthorizes important programs for medical product development, and more
Introduced legislation builds on discussion draft with new steps to strengthen the accelerated approval pathway, over-the-counter hearing aids, FDA inspections
Murray: “This legislation will help keep families safe, provide long overdue oversight of cosmetics and dietary supplements, bring new medical products—including cheaper generic and biosimilar drugs—to market, and ensure the drug approval process prioritizes patients over companies’ bottoms lines.”
Burr: “This bipartisan bill marks an important step in building off those successful partnerships to ensure FDA’s review and approval process remains nimble and forward-looking for the next generation of medical products, treatments, and cures.”
Washington, D.C. – Today, Senate Health, Education, Labor and Pensions (HELP) Committee Chair Senator Patty Murray (D-WA), and Ranking Member Senator Richard Burr (R-NC), introduced the FDA Safety and Landmark Advancements (FDASLA) Act—legislation reauthorizing the Food and Drug Administration’s (FDA) prescription drug, generic drug, biosimilar, and medical device user fee agreements. The legislation also includes provisions to strengthen oversight of cosmetics and dietary supplements, modernize the regulation of diagnostic tests, bring more competition to the market, and prepare the FDA for the next generation of medical products to benefit Americans.
“We need FDA to live up to its responsibility to keep families safe—and part of that is making sure it has the resources and authority it needs to carry out its mission,” said Senator Murray. “That’s why I worked in this bipartisan bill to take important steps and ensure the products families in Washington state entrust their health to every day are safe and effective. This legislation will help keep families safe, provide long overdue oversight of cosmetics and dietary supplements, bring new medical products—including cheaper generic and biosimilar drugs—to market, and ensure the drug approval process prioritizes patients over companies’ bottoms lines. I’m going to continue working with Senator Burr and our colleagues to get this legislation passed, and I’m also going to keep pressing FDA to step up its efforts on challenges like the opioids epidemic, skyrocketing drug prices, and the ongoing formula shortage. Families deserve better, and I’ll keep pressing to make sure they get it.”
“Throughout the pandemic, FDA and the private sector worked with unprecedented speed to bring life-saving vaccines and therapeutics to Americans,” said Senator Burr. “This bipartisan bill marks an important step in building off those successful partnerships to ensure FDA’s review and approval process remains nimble and forward-looking for the next generation of medical products, treatments, and cures. As the Committee continues to examine FDA’s role in creating, and then its failure in solving, the infant formula shortage, we must consider whether FDA is capable of receiving even more responsibilities in these agreements, when it’s clear the agency has struggled with the responsibilities they already have. That’s why it’s critical this package includes key measurement standards to hold the agency accountable to meeting its commitments related to medical product review and to address the work that must be done to fix the broken systems FDA relies on. I look forward to working with my colleagues as we finalize this important package.”
The Senators developed the legislation following hearings with FDA officials and stakeholders last month, and after receiving input from the public and stakeholders on the discussion draft they introduced last week. The Committee will mark up the legislation in the coming weeks.
In addition to reauthorizing the FDA’s user fee agreements—and ensuring that the FDA can continue its critical work approving prescription drugs, generic drugs, biosimilars, and medical devices and fostering innovation—FDASLA also includes steps to:
Section-by-Section of FDASLA HERE.
Full text of FDASLA HERE.