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FDA must-pass bill poised for Senate consideration

The Senate is poised to soon complete its work on a must-pass bill aimed at renewing the Food and Drug Administration's authority to collect user fees from drugmakers — funds the agency relies on for more than half its budget.

Senate Majority Leader Mitch McConnell, R-Ky., Aug. 1 filed cloture on the bill — a procedure intended to limit the amount of time legislation is debated on the chamber's floor.

The Senate could vote on the Food and Drug Administration Reauthorization Act of 2017, or H.R. 2430, as early as Aug. 3.

The House unanimously passed its version of the bill July 12 in a voice vote.

The legislation has been sitting on the Senate's calendar since July 17, but lawmakers were occupied with the Republicans' effort to pass legislation aimed at dismantling the Affordable Care Act — a pursuit McConnell has set aside for the time being after failing last week on his third attempt.

The user fee bill was one of McConnell's priorities to wrap up before the Senate departed for its summer recess — a break the majority leader delayed by two weeks to give senators time to work on healthcare and other matters, including the FDA legislation.

"This program is critical to speeding up the drug approval process, and that's important for everyone frustrated by the time and cost of bringing lifesaving drugs to market," McConnell said Aug. 1 on the Senate floor. "Without it, the important work of ensuring that drugs and devices are safe and effective would come to a screeching halt."

The FDA legislation would renew the agency's authority to collect user fees from makers of prescription brand-name drugs, medical devices, generic medicines and lower-cost versions of biologics, or biosimilars.

Under the programs, the industry agrees to pay the fees used to support FDA application reviews and manufacturing facility inspections and in exchange the agency needs to meet certain performance goals.

User fees revolutionized FDA

Since the user fee program was first instituted in 1992, the share of brand-name medicines that get approved in the U.S. before they are approved anywhere else in the world has grown to 66% from 10% previously, according to the FDA. The program has been renewed every five years. Programs for generics, medical devices and biosimilars came on board later.

The generics user fees have helped the FDA essentially dissolve its application backlog — it had about 3,000 applications pending before the enactment of the first round of that program in 2012, officials testified in March.

"The user fees have revolutionized the way the FDA approves medical products," Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, told lawmakers at the March 21 Senate hearing.

The current five-year authorization for all four programs expires Sept. 30.

The FDA was set to start sending out layoff notices in light of the uncertain situation. But FDA Commissioner Scott Gottlieb on July 24 told agency scientists and other workers that because there was a reasonable expectation the Senate would act by the deadline, he did not anticipate initiating the process before that date.

It's unclear, however, if President Donald Trump will sign the user fee bill. His fiscal year 2018 budget proposal called for industry to fund 100% of the costs for the FDA's premarket review and approval activities for drugs and biologics — cutting the amount of money the agency would get from taxpayers.

But Sen. Patty Murray, D-Wash., ranking member on the Senate's Health, Education, Labor and Pensions, or HELP, Committee, said that plan would leave the FDA financially hamstrung.

Republicans, including Sen. Lamar Alexander, chairman of the HELP Committee, have rejected Trump's proposal.