FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

E&C Committee Reviews 340B Drug Pricing Program, Offers Recommendations

Jan. 17, 2018
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The House Energy and Commerce Committee released a review of the 340B drug discount pricing program, identifying weaknesses in oversight and administration, among other issues, and offering recommendations to resolve them.

The program’s participation rate has more than quadrupled in the past decade, raising concerns that the Health Resources and Services Administration (HRSA), which oversees and administrates the program, may no longer have the resources to do so effectively, according to the committee.

The HRSA needs more regulatory authority to clearly define program requirements and ensure program integrity and compliance, the committee said, noting a 2014 federal court ruling limited HRSA’s authority to oversee the program.

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