Congress has passed a stop gap funding bill that includes the reauthorization of the US Food and Drug Administration’s user fee programs. The reauthorization would avert layoffs at FDA and secures funding for numerous initiatives at the agency that arose from months of negotiations with industry.
While Democratic lawmakers had hoped to attach several key riders to the reauthorization package, they were ultimately nixed to ensure Republican support for the bill. (RELATED: Lawmakers attach user fees to CR, plan to revisit riders after mid-terms, Regulatory Focus 27 September, 2020)
On 30 September, the continuing resolution, which reauthorizes FDA’s user fee programs covering drugs, generics, biosimilars and medical devices, was passed by the House in a 230-201 vote; a day after the Senate passed the measure 72-25. The bill now heads to President Biden’s desk where it is expected to be signed today to avoid a partial government shutdown.
The new user fee programs include increased funding from drug and device makers that are meant to help FDA hire more staff, modernize its IT systems and create new processes to speed products to market.
The user fee reauthorization bill hit a snag in July when Sen. Richard Burr (R-NC), ranking member of the Senate Health, Education, Labor and Pensions (HELP) committee, proposed a “clean” user fee bill after Democrats and Republicans had already negotiated a number of riders over the summer. Ultimately, with time running out to get the bill passed, Democrats conceded and tabled the riders. (RELATED: Burr introduces stripped-down user fee bill, Regulatory Focus 14 July 2022)
Frank Pallone (D-NJ), chair of the House Energy and Commerce (E&C) committee, bemoaned the setback on the riders, which included reforms for diagnostics, dietary supplements and cosmetics.
“After weeks of negotiation, our talks hit a temporary roadblock with Senator Burr… But we stayed at the table, and eventually the negotiations were fruitful. We were able to come together to find common ground across several meaningful policy areas,” said Pallone. “Unfortunately, despite this progress, Senate Minority Leader [Mitch McConnell (R-KY)] decided to stand in the way of enacting bipartisan policies to improve public health. Senator McConnell threatened to hold up government funding if our FDA reforms were included in the continuing resolution we are debating today.”
“I have secured commitments from Senators [Patty Murray (D-WA)] and Burr, as well as [E&C] Ranking Member [Cathy McMorris Rodgers (R-WA)], to continue working to finalize a package of FDA reforms before this continuing resolution expires in December, and I look forward to taking meaningful action in the near future,” he added.
HELP committee Chair Murray said she’s happy Congress was able to pass the funding bill to keep the federal government open but also disappointed it did not include key riders, such as additional COVID-19 and monkeypox funding.
“This bill provides vital support to Ukraine to continue their progress against Russia in Putin’s war, reauthorizes the user fee programs so the FDA isn’t forced to send out pink slips, secures disaster relief for communities recovering from severe climate events, and helps families stay warm this winter by supporting a program that lowers energy costs for millions of households—including nearly 80,000 in Washington state alone,” Murray said.
Murray added that she plans to continue working with lawmakers to pass the other riders that were not included in the bill. The measure only keeps the government funded until 16 December at which point Congress will need to pass a budget bill for the next fiscal year and opens the door for lawmakers to bring back the riders that were pulled out.
Immediately after the House passed the bill, FDA Commissioner Robert Califf emailed agency staff thanking them for their patience and continued service. In late July, he warned staff that if Congress didn’t pass a user fee reauthorization bill, the agency would have to send out letters warning staff they may be laid off. He also warned lawmakers that failure to renew the programs would have immediate and long-term consequences for the agency. (RELATED: Califf seeking Congressional assurance user fees won’t run out, Regulatory Focus 1 August, 2022)
“Over the next five years, the user fee program commitments will focus on critical elements that will support review performance, program improvements, hiring and retention, performance accountability and financial transparency,” said Califf in his latest letter to staff. “While the user fee reauthorization package passed by Congress did not include additional policy changes that we believe would benefit public health, we remain committed to working with Congress on these policies… We will also focus attention on the policies that are very important to public health so that we can bring them through Congress by year end.”
AdvaMed CEO Scott Whitaker thanked lawmakers for reauthorizing the medical device user fee program as part of the bill and described it as a “historic five-year agreement” that will usher in a new era of innovation and give medtech manufacturers greater predictability, consistency, accountability, and communication with the FDA.
“We are in a golden age of medical technology innovation, and the improvements made by MDUFA V will serve as a catalyst for even greater health care transformations,” he added.
Peter Saltonstall, president of the National Organization for Rare Disorders (NORD), also applauded Congress for passing the user fee reauthorization bill and warned a lapse in funding would have been devastating to patients with rare diseases.
“NORD is deeply concerned that Congress included only a short-term reauthorization of other critical programs like the orphan drug grants program and failed to include several bipartisan policy reforms important to the rare disease community,” he added. “We urge Congress to immediately enact a full five-year reauthorization of the important programs that support rare disease drug development and resume negotiations on the numerous FDA reforms, such as those around accelerated approval and orphan drug exclusivity, that have broad bipartisan support and would directly benefit the rare disease community.”
PhRMA CEO Stephen Ubl also thanked lawmakers for renewing user fees and emphasized it will bring predictability to regulations and biopharmaceutical innovation.