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
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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