Congress Passes FDA User-Fee Reauthorization Bill

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Following passage by the House in July 2017, the Senate has voted to pass a reauthorization bill for FDA user-fee programs for drugs and medical devices ahead of the user-fee programs’ expiration date.

On August 3, 2017, the US Senate passed the FDA Reauthorization Act of 2017 (H.R. 2430) for FDA user-fee programs for prescription drugs, generic drugs, medical devices, and biosimilars. The legislation allows for FDA to continue collecting fees over the next five years from drug and medical device makers to review applications for these products, according to various media outlets. The bill now goes to President Trump for signing.

Passage of the bill follows several months of negotiations between FDA and industry stakeholders over the user fees, which are authorized every five years. The current user-fee programs are scheduled to expire at the end of September 2017. The US House of Representatives approved the reauthorization bill in July 2017. Included in the bill are the following user fee programs: Prescription Drug User Fee Act (PDUFA VI), Generic Drug User Fee Amendments (GUDFA II), Biosimilar User Fee Act (BsUFA II), and Medical Device User Fee Act (MDUFA IV).

Commenting on the Senate’s vote, Pharmaceutical Research and Manufacturers of America (PhRMA) President and CEO Stephen Ubl issued the following statement: “PhRMA applauds the Senate for passage of the Prescription Drug, Biosimilar, and Generic Drug User Fee Acts. PDUFA VI better incorporates real-world evidence and patient perspectives into the drug development and approval process, while also providing [FDA] with new tools and resources to keep up with the latest scientific advances. By strengthening FDA and improving efficiency in the drug review process, we can bring safe, innovative medicines to patients faster, which will enhance competition and lower costs. This is a major victory for medical innovation, FDA, and patients.”

Biotechnology Innovation Organization (BIO) President and CEO James Greenwood echoed the sentiment in a statement on the organization’s website: “The user fee program reauthorization package passed by the Senate … is an important victory for patients and for the next generation of medical innovation. This legislation … ensures that FDA continues to have the resources necessary to carry out its critical human drug review programs, and takes steps to modernize and improve the clinical trial process, which remains the most time-consuming, complex, and expensive stage of drug development.”

“The reauthorization of the biosimilars user fee program, including steps to improve communication between FDA and Sponsors throughout application review, will create a more robust and competitive marketplace for biosimilar therapies, following an appropriate period of exclusivity for innovator biologic products,” Mr. Greenwood said in the statement.


The Society of Chemical Manufacturers and Affiliates (SOCMA) also weighed in, commending the Senate on passing the bill. SOCMA’s affiliate, the Bulk Pharmaceuticals Task Force (BPTF), was a stakeholder in negotiating the terms of GDUFA with FDA.

“It was a long negotiation process, but we are pleased to see the bipartisan support in Congress in reauthorizing this important piece of legislation,” said John DiLoreto, BPTF executive director, in a SOCMA press release. “Approval of GDUFA allows the federal government to continue to work toward bringing generic drugs to consumers faster than ever, and the new fee structure will significantly reduce the costs for active pharmaceutical ingredient (API) manufacturers, which are our members.”

The Pharma & Biopharma Outsourcing Association (PBOA), a trade group that represents contract manufacturing organizations (CMOs) and other service providers in the bio/pharmaceutical sector, also applauded the Senate’s decision. “Our members commend the Senate for its passage of the FDA Reauthorization Act, including [GDUFA]. GDUFA II will not only empower FDA and industry to work toward swifter approval of cost-lowering generic drugs, it will also employ a fairer fee structure that better reflects the economic models of the various stakeholders. PBOA worked extensively with FDA and other industry groups to achieve those goals, and we are happy to see the program-along with three other major user fees-advance through the legislative process,” said Gill Roth, president of PBOA, in a statement on the association’s website.

Source: US House of Representatives, PhRMA, BIO, SOCMA, and PBOA