FDAnews Drug Daily Bulletin

Feds Say They Are Out of Options to Improve 340B Transparency

July 24, 2017

Any major changes to the way the 340B drug discount program is regulated and overseen will require action from Congress, experts told a House subcommittee in a July 18 hearing.

The HHS arm that oversees the discounted drug pricing program has made some improvements to its operations since 2011 -- when a GAO study found oversight of the program was inadequate -- but it lacks regulatory authority to make other needed changes.

GAO had previously recommended that the Health Resources and Services Administration’s take various steps, including auditing manufacturers and dispensaries, clarifying guidance for manufacturers, better defining eligible patients, and providing more specific hospital eligibility criteria.