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Tying FDA Fees to Stopgap Bill Seen as Missed Chance for Change

Sept. 16, 2022, 9:25 AM

Health policy advocates are wary that a push to attach FDA user fee legislation to a government funding bill will deny the agency new drug approval oversight tools and other long-sought policy changes.

Senate health committee leaders said this week that they’re aiming to get user fee reauthorization language added to a continuing resolution that would keep the government funded past September. Analysts say the move would be a first for reauthorizing the industry fees that fund roughly half of the Food and Drug Administration’s budget.

But Republicans have said they want a “clean” stopgap funding bill with few policy riders. And Sen. Richard Burr (R-N.C.), ranking member of the committee, has been pushing a version of user fee legislation that omits many proposals to revamp agency regulations.

It’s “just really unfortunate and really a missed opportunity” if Congress tacks on a stripped-down version of user fee authorization to the CR, said Reshma Ramachandran, a Yale School of Medicine family physician and the FDA task force chair for Doctors for America.

It shows “the user fees will prioritize industry needs instead of what patients need, which is really truly effective and safe medication and devices,” she said.

Drug and device makers pay user fees to the FDA to help speed up product reviews, and in exchange, the agency agrees to meet specific performance goals. Lawmakers must reauthorize user fees for the next five fiscal years by Sept. 30.

The FDA could have to lay off thousands of employees if an agreement is not reached by the deadline.

The agency said in an email Wednesday that “it is critical that Congress reauthorize the user fee programs this fiscal year,” and that it “has no objection to whatever vehicle Congress determines is appropriate to pass the 5-year reauthorizations this month.”

Lawmakers have yet to release text of a stopgap measure, and Congress is poised to wrap up the week without a firm plan to fund the government past this month.

A continuing resolution deal is being held up by talks to add a bill to streamline the energy permitting process. Senate Republicans have criticized the Democratic leadership for accepting Sen. Joe Manchin (D-W.Va.)’s proposal as a side deal to the recently enacted tax, climate, and drug-pricing law.

Changes in Limbo

The House passed a sweeping user fee reauthorization package in June that included a proposal to revamp the FDA’s accelerated approval pathway, which gained renewed scrutiny after Biogen Inc.‘s Alzheimer’s drug approval. The Senate Health, Education, Labor, and Pensions Committee advanced a separate package that also included accelerated approval changes as well as measures to improve baby formula oversight.

The accelerated approval measures would allow the FDA to remove from the market any drugs that obtained quick approval if they fail to show a clinical benefit.

But user fee negotiations hit a roadblock in July when Burr proposed his own package that left out several proposals from the HELP committee version.

Burr has argued that policies added to the user fee bill “endanger the development of drugs for rare diseases, imperil intellectual property rights,” and “threaten Americans’ access to breakthrough treatments and cures.”

The policy proposals included in the House and Senate HELP packages now remain in limbo as lawmakers negotiate what goes in the continuing resolution.

Sen. Richard Shelby (R-Ala.) told Bloomberg Government on Sept. 13 that he and his Republican colleagues don’t want any policy riders complicating passage of a stopgap funding bill.

“The thinner the better,” Shelby said when asked about attaching user fees to the measure.

Senate Minority Leader Mitch McConnell (R-Ky.) has said a continuing resolution should be “as clean as possible.”

A Republican aide familiar with the discussions told Bloomberg Government Thursday that Burr is holding strong in asking for a five-year user fee extension free of policy riders. Meanwhile, Sen. Patty Murray (D-Wash.), the Senate HELP chair, is pushing for riders and wants to see an agreement that’s as close as possible to the package advanced by the HELP committee.

Policy Proposals

An industry source told Bloomberg Law that to ensure passage of a stopgap funding measure, proposals around dietary supplements and cosmetics are unlikely to make it through. The package advanced by the Senate HELP committee would require manufacturers and distributors of dietary supplements to register their products with the FDA.

While some industry groups have supported this proposal, the Natural Products Association, which represents more than 10,000 manufacturers and retailers of foods and dietary supplements, has argued that the bill would create unnecessary bureaucratic barriers for industry.

Senate Majority Whip Dick Durbin (D-Ill.), who sponsored the supplements bill, told Bloomberg Government on Thursday that Sen. Patty Murray (D-Wash.), the Senate HELP chair, told him this week she’s “working on” getting his proposal into the user fee agreement that will be attached to the CR.

The House-passed user fee package included provisions allowing the FDA to require drug and device companies to submit diversity action plans for their clinical trials. Those didn’t make it into the Senate HELP package, but Ramachandran said the Doctors for America task force is talking to congressional staff this week to get those and the accelerated approval provisions added into the CR.

Another proposal to boost pediatric cancer research is in the House package but not in the one advanced by Senate HELP. Murray said during the June markup that she would continue working to advance it.

Nancy Goodman, founder and executive director of nonprofit group Kids v Cancer, helped craft the bill and said she hopes that if any riders are added to a continuing resolution, this will be one of them.

To “not attach this pediatric cancer provision, which would require combination pediatric cancer studies and lead to better treatments and more cures for kids with cancer, would endanger the development of new pediatric cancer drugs and cures,” she said.

Avoiding Disruptions

With two weeks left before the Sept. 30 deadline, the main goal for lawmakers at this point is to guarantee user funding and prevent disruptions to the agency’s day-to-day work.

An industry source told Bloomberg Law that Democrats are focused on cutting a deal that would prevent FDA layoffs, noting that no one wants to be responsible for disrupting the agency’s ongoing response to the Covid-19 pandemic and monkeypox outbreak.

The threat of a lapse in user fee funding also “has a morale effect that preoccupies people,” within the FDA, said Howard Sklamberg, a former FDA deputy commissioner.

“It becomes harder for them to do their work,” he added. “The agency has to put together all sorts of contingency plans about how to staff things.”

Sklamberg said a user fee reauthorization without policy riders doesn’t necessarily mean long-sought reforms won’t eventually move forward.

Murray and others could work to move forward accelerated approval and other changes in December after the midterm elections, Ramachandran said. But “the momentum and the lessons learned from the past few years around the FDA will be lost” by then.

“During this lame duck part of Congress, there might not be much motivation to move forward with a comprehensive public health package,” she said.

To contact the reporters on this story: Celine Castronuovo at ccastronuovo@bloombergindustry.com; Alex Ruoff in Washington at aruoff@bgov.com

To contact the editors responsible for this story: Alexis Kramer at akramer@bloomberglaw.com; Karl Hardy at khardy@bloomberglaw.com