American Society of Hematology

Senate Likely to Take Up FDA Bill on User Fee Programs & Drug Shortages May 21

Published on: May 16, 2012

Legislation concerning Food and Drug Administration user fee programs and drug shortages is picking up speed with the Senate planning to start consideration the week of May 21 and the House of Representatives considering its version after Memorial Day.

The Senate will work on a new version of the bill (S. 3187), which was introduced by Senators Tom Harkin (D-IA) and Michael Enzi (R-WY).

The bill features new sections that have been negotiated since the committee approved its measure (S. 2516) in April. Further changes are expected to come once the bill is considered by the full Senate.

The new bill would continue through 2017 an FDA grant program for clinical studies of products that treat rare diseases where no current therapies exist, or where the potential product would be superior to the existing therapy. The House version of the bill (HR 5651)) also would reauthorize the grant program.

In addition, the new Senate bill would allow the FDA to accept data from clinical studies conducted outside of the United States when determining whether to approve a drug or device, as long as the data are shown to meet standards for approval in the United States.

The Senate measure also would require a report on ways to accelerate the development of new therapies for rare pediatric diseases and require the agency to take patients’ perspectives into account during regulatory discussions.

Versions of the legislation, which would reauthorize the user fee programs that help fund the FDA’s reviews of prescription drugs and medical devices, have advanced through committee in both chambers. The current law expires Sept. 30, but Congressional leaders plan to get a measure to the president’s desk well before then.

The House and Senate bills both would create user fee programs for generic drugs and generic biologic drugs, or biosimilars, and include provisions that would address drug shortages, the safety of the drug supply chain and other issues.

The new legislation does not appear to address all of the issues lawmakers were hoping to add to the measure. For example, it does not include a provision to allow the importation of lower-priced prescription drugs from Canada. It also does not include a proposal to get around the “pay for delay” deals that brand-name drug companies sometimes make with generic manufacturers who make cheaper versions of medicines.

ASH continues to advocate for strengthening the drug shortage provisions. Specifically, the Society has recommended that the legislation include biological products, including products derived from human plasma proteins and human tissue replaced by recombinant products; civil monetary penalties; and economic incentives. More information about drug shortages and ASH advocacy is available on the ASH website.

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