Senate HELP Committee Introduces FDA Safety and Landmark Advancements Act

The 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 as well as 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, said according to the committee.

You can track the progress of the legislation here.

“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 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 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 in April, 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:

• 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;
• Strengthen FDA’s accelerated approval pathway;
• Update the process for determining therapeutic equivalence of certain drugs;
• Expedite consumer access to over-the-counter hearing aids;
• Enhance coordination and transparency of FDA inspections; 
• Expand the successful hiring authorities authorized by the 21st Century Cures Act to include new hiring authorities to staff offices that oversee food, including infant formula, 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.