Industry and consumer groups have welcomed the US Senate’s near-unanimous approval of legislation to reauthorise Food and Drug Administration (FDA) user fee agreements, and the House is expected to vote on a similar bill as early as this week.
The FDA User Fee Reauthorization Bill (S 3187) is the “backbone” of the Food and Drug Administration Safety and Innovation Act (FDASIA) – which the Senate approved last week on a 96-1 vote – said Democrat Tom Harkin, chair of the Senate Health, Education, Labour and Pensions (HELP) Committee, which drew up the bill. Ahead of the vote, Sen Harkin had told legislators that it was “absolutely imperative” that they reauthorise the user fee agreements before they expire on September 30.
‘If we don’t, FDA will lose 60% of its drug centre budget and 20% of its device centre budget. It will have to lay off nearly 2,000 employees, which would grind the drug and device approval processes to an unacceptably slow pace, with devastating consequences for patients whose health and lives depend on new medical treatments,” he said.
“After months of negotiation, FDA and industry have crafted win-win agreements that they stand behind,” and their implementation “will continue to foster biomedical innovation and job growth in our states during these tough economic times,” he added.
The bill reauthorises the Prescription Drug User Fee Act (PDUFA) which, according to the Congressional Budget Office (CBO), will require drugmakers to pay fees worth $4.1 billion over the next five years, and the Medical Device User Fee Act (MDUFA) – $609 million over five years. It also authorises two new agreements – the Generic Drug User Fee Act (GDUFA) – five-year user fees totaling $1.6 billion – and the Biosimilars User Fee Act (BsUFA) – $128 million. Also, it permanently reauthorises the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA).
GDUFA is expected to slash review times for generic products from 30 months to 10 months, while BsUFA “will further spur innovation by shepherding the budding generic biologics industry as it matures,” said Sen Harkin.
Other provisions of FDASIA seek to: – modernise FDA’s global drug supply chain authority; – spur innovation and incentivise drug development for life-threatening conditions; – help prevent and mitigate drug shortages; and – increase FDA’s accountability and transparency, Sen Harkin told the Senate. What’s more, according to CBO estimates, it will reduce the budget deficit by more than $363 million over the next decade, he said.
After “well over a year of diligent bipartisan work” on FDASIA, “I believe we have hit the sweet spot,” said Sen Harkin.
The one vote against the FDA bill was cast by Vermont’s Independent Senator, Bernie Sanders, who said it would “perpetuate a system that makes Americans pay far more for medicines than people anywhere else.”
“I voted against this bill because it does far too little to address this crisis while it perpetuates a prescription drug system that continues to fail the American people,” said Sen Sanders.
An amendment to the Act sponsored by Senators John McCain (Republican) and Sherrod Brown (Democrat), which would have permitted re-imports of FDA-approved drugs from Canada and other nations, failed to gain majority support in the Senate, winning just 43 votes.
– Earlier this month, Sen Sanders introduced The Prize Fund for HIV/AIDS Act, which would de-link R&D incentives from drug prices for new HIV/AIDS drugs and create instead a $3 billion annual prize fund to reward the discovery of new treatments.
