Update: On May 26, updated versions of the VALID LEGISLATION and ONE PAGER were released.
ACLA public comments (probably on the earlier draft) here:
On May 17, 2022, Sens. Murray and Burr released draft legislation for FDA changes, including LDT regulation.
See early coverage at Genomeweb here. Back in March 2022, Genomeweb ran a subscription review of issues and debates in this area, here.
Submit feedback til May 22, 2022. (See contact info at bottom of press release below).
FOR IMMEDIATE RELEASE:
May 17, 2022
Anali Alegria: 202-224-5398 (Murray)
Caitlin Carroll: 202-228-1616 (Burr)
Senators Murray, Burr Release Legislation to Support FDA Programs to Lower Costs and Spur Innovation
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
Murray: “Families want to know the products they entrust their health to are safe and effective—which is why this bipartisan legislation is so important.”
Burr: “This bipartisan draft strengthens FDA’s foundation to ensure our review and approval process is ready for the next generation of innovative products.”
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), released a discussion draft of 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.
“Families want to know the products they entrust their health to are safe and effective—which is why this bipartisan legislation is so important. This legislation will ensure FDA has the resources it needs to do its work—and will enable the agency to finally provide serious oversight of the cosmetics and dietary supplements people in Washington state use every day,” said Senator Murray, “I’m also laser-focused on lowering drug prices, and that’s why this legislation increases competition by helping cheaper generic and biosimilar drugs get to market and ensuring drug approvals are always driven by what is best for patients and families—not pharmaceutical companies’ bottom lines. I look forward to working with Senator Burr and my colleagues to strengthen this legislation further and get it passed into law.”
“The COVID-19 pandemic demonstrated the critical partnership of the FDA and private sector in bringing a range of tests, treatments, and vaccines to Americans in record time,” said Senator Burr. “As we transition into a new normal, it’s essential that the agency use the same urgency to bring life-saving treatments and cures to Americans suffering from other devastating diseases, like cancer or Alzheimer’s. This bipartisan draft strengthens FDA’s foundation to ensure our review and approval process is ready for the next generation of innovative products. It also includes key measurements to ensure the agency meets its commitments and modernizes our diagnostic testing framework to bring certainty to test developers and give Americans confidence in their health care decisions. I look forward to working with my colleagues as we finalize this significant bill to ensure it not only reflects the best deal for Americans, but also holds the FDA accountable to its performance commitments for years to come.”
The Senators developed the discussion draft following hearings with FDA officials and stakeholders last month, and plan to introduce and mark up a final version of 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 drug, generic drug, biosimilar, and medical devices and fostering innovation—the discussion draft of FDASLA also includes steps to:
- Strengthen oversight of cosmetics and dietary supplements;
- Improve regulation of diagnostic tests—including COVID tests;
- Bring more competition to the market to lower drug prices;
- Increase safe disposal of opioids and other drugs with serious risks;
- Modernize the data that can be used to support medical product development, including alternatives to animal studies;
- Expand the successful hiring authorities authorized by the 21st Century Cures Act and require a Strategic Workforce Plan to help strengthen FDA’s workforce; and,
- Ensure FDA is transparent and accountable for the user fees it collects from industry.
Feedback on the discussion draft should be submitted to firstname.lastname@example.org by May 22, 2022.
Section-by-Section of FDASLA Discussion Draft HERE.
Full text of FDASLA HERE.