Lawmakers Revise Bill to Speed Generic Drug Approvals, Lower Drug Costs


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 me March 6.

Among other things, 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.

“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 me. 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.

Janet Woodcock, the director of the Center for Drug Evaluation and Research, said March 2 that 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.

Woodcock spoke during a House Energy and Commerce Health Subcommittee hearing on the bill and the FDA's generic drug and biosimilar user fee programs.

Read my full article here.

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