Lawmakers Revise Bill to Speed Generic Drug Approvals

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By Bronwyn Mixter

A House bill aimed at getting more generic drugs on the market won’t be moving on a fast track to markup.

The legislation ( H.R. 749) is intended to lower drug prices by introducing more generic drug competition. Drugmakers are under heavy scrutiny by lawmakers, consumers, medical professionals and the president for their pricing practices.

The measure was introduced Jan. 30 by Reps. Gus Bilirakis (R- Fla.) and Kurt Schrader (D-Ore.). The sponsors and House Energy and Commerce Committee staff are working on a bipartisan basis to revise the bill before it is considered by the committee, a committee aide told Bloomberg BNA in a March 6 email.

The bill would require the Food and Drug Administration to prioritize and act on generic applications within 180 days of being filed for drug products that are in short supply or when there are too few manufacturers on the market. It also would increase transparency on the generic drug application backlog at the FDA.

“There are a group of drugs where there’s not a lot of competition where this could help expedite the review process if FDA would be able to meet that 180-day time clock,” David Rosen, an attorney with Foley & Lardner LLP in Washington, told Bloomberg BNA March 6. Rosen is the chair of the firm’s FDA regulatory practice and was employed at the FDA for 14 years.

However, some, including the head of the FDA’s drug center, don’t think a 180-day review period is possible.

The bill also would create a transferable priority review voucher that the FDA would award to a manufacturer that brings a generic drug to market when a branded product doesn’t have any competition.

Priority review vouchers exist for new branded drug products. Rosen said that for branded drug products, vouchers have “meant a lot of money,” mainly because these vouchers can be sold to other companies for a priority review of a different drug. Rosen is a Bloomberg BNA health-care advisory board member.

Generic User Fee Legislation

The bill was examined along with the FDA's generic drug and biosimilar user fee programs at a March 2 Energy and Commerce Health Subcommittee hearing.

Bloomberg Intelligence Analyst Brian Rye told Bloomberg BNA March 6 there’s a “very good chance” that H.R. 749 gets added to legislation that reauthorizes the generic drug user fee program.

Congress is preparing to consider legislation to reauthorize the laws governing industry-paid user fees that help fund the FDA. All four user fee programs—for prescription drugs, generic drugs, medical devices and biosimilars—expire Sept. 30. After that, new legislation will be needed to reauthorize the programs for fiscal years 2018 through 2022. The FDA and industry have already come up with agreements for reauthorizing the programs, which will serve as the basis for the legislation.

Is 180-Day Review Possible?

Whether the FDA could review a generic product within 180 days is unclear.

Allan Coukell, senior director for health programs at the Pew Charitable Trusts, said in his written testimony for the March 2 hearing “it is important to note that FDA already prioritizes generic applications when there is only one competing product on the market.”

“The net benefits and practical feasibility of a six-month review are unclear as is, consequently, the market value of a priority review voucher for generic applications,” Coukell said. “Perhaps more important than shortening the duration of review is reducing the number of review cycles.”

Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research (CDER), said at the hearing the agreement to reauthorize the Generic Drug User Fee Amendments, called GDUFA II, would require the agency to review priority generic drug applications within eight months of submission. Standard applications would be reviewed within 10 months.

Woodcock said the FDA can’t get too much quicker than an eight-month review, because the agency needs time to inspect the facilities where these products are made and some of the facilities are in foreign countries. When asked what Congress can do to help the FDA, she said it should pass GDUFA II.

To contact the reporter on this story: Bronwyn Mixter in Washington at

To contact the editor responsible for this story: Brian Broderick at

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