U.S. Sen. Richard Burr (R-NC) on May 26 proposed sweeping bipartisan legislation to reauthorize the Food and Drug Administration’s (FDA) prescription drug, generic drug, biosimilar, and medical device user fee agreements.
“Throughout the pandemic, FDA and the private sector worked with unprecedented speed to bring life-saving vaccines and therapeutics to Americans,” said Sen. Burr, ranking member of the U.S. Senate Health, Education, Labor and Pensions (HELP) Committee. “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.”
The 433-page FDA Safety and Landmark Advancements (FDASLA) Act, S. 4348, which Sen. Burr cosponsored alongside bill sponsor U.S. Sen. Patty Murray (D-WA), also includes numerous provisions to strengthen oversight of cosmetics and dietary supplements, modernize the regulation of diagnostic tests, and enhance market competition, according to the lawmakers.
“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,” Sen. Burr said. “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.”
Among numerous provisions, S. 4348 also would increase the safe disposal of opioids and other high-risk drugs; update the data that can be used to support medical product development; bolster the FDA’s accelerated approval pathway; improve the process for determining therapeutic equivalence of certain drugs; expedite consumer access to over-the-counter hearing aids; and enhance the coordination and transparency of FDA inspections.
“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 Sen. Murray, chair of the HELP Committee. “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.”
According to their staffs, the senators developed S. 4348 following hearings in April with both FDA officials and other stakeholders, and after receiving public comments on the discussion draft of the bill that they released in May.
S. 4348 has been referred for consideration to the Senate HELP Committee.