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Before leaving Washington for a delayed August recess, the Senate voted 94-1 to approve legislation reauthorizing user fees and a series of program changes critical to maintaining a smoothly functioning FDA medical product review and approval process.
Before leaving Washington for a delayed August recess, the Senate voted 94-1 to approve legislation reauthorizing user fees and a series of program changes critical to maintaining a smoothly functioning FDA medical product review and approval process. The fees included in the FDA Reauthorization Act (FDARA) will generate $8-9 billion over 5 years to support regulatory oversight of prescription drugs and biologics, generic drugs, medical devices and biosimilars.
The Trump administration had called for a major increase in industry-paid fees to fully support relevant FDA regulatory programs, but that would have involved redoing the two-year negotiating process between FDA officials and industry representatives to reach agreement on review and approval goals and new regulatory policies. It also challenged the basic concept that FDA operations should be support by public revenues, and not just by industry fees.
The Senate action on Aug. 3, 2017 followed approval of a new “right-to-try” law sponsored by Sen. Ron Johnson (R-Wis), who had threated to block the vote on FDARA without consideration of this measure to facilitate access to experimental therapies for seriously ill patients. The House of Representatives still must approve the measure after it returns in September. Biopharma companies muted their opposition to the bill, despite long-held concerns that broadening use of unapproved and unproven treatments would undermine the clinical testing needed to sufficiently document drug safety and efficacy to support market approval. The bill was revised recently to clarify that manufacturers, prescribers and dispensers will not be held liable for patient use of investigational drugs under the measure.
The user fee legislation did include provisions to speed FDA approval of generic drugs with limited competition, to broaden clinical trial eligibility to make studies more inclusive, to encourage development of pediatric treatments for cancer and other serious conditions, and to improve communication about abuse-deterrent opioids. However, proposals to permit imports of drugs from Canada and to require reasonable price agreements on prescription drugs were blocked.
The reauthorization of these user fees before the current fee programs expire Sept. 30, 2017 relieves FDA of the need to alert thousands of staffers to potential layoffs if sufficient funding is not available to the agency. FDA commissioner Scott Gottlieb provided breathing room on this process by announcing in late July that the agency would delay sending out such notices until the end of September, based on the expectation that the fees would be renewed in time.
Enactment of a relatively “clean” user fee bill will simplify FDA’s process for implementing the measure. The agency already is deeply involved in scheduling a host of meetings, guidances and reports required by the 21st Century Cures Act, which was enacted late last year, and timely approval of the new user fee programs will help further that process.