PhRMA Sues to Stop 340B Pricing for Orphan Drugs

The pharmaceutical lobby has filed a lawsuit seeking to block implementation of a federal rule that allows healthcare providers that participate in the 340B drug discount program to buy orphan drugs at reduced prices if the drugs are used to treat non-orphan conditions or diseases.

The pharmaceutical lobby has filed a lawsuit seeking to block implementation of a federal rule that allows healthcare providers that participate in the 340B drug discount program to buy orphan drugs at reduced prices if the drugs are used to treat non-orphan conditions or diseases.

In the lawsuit filed Sept. 27 in the U.S. District Court for the District of Columbia, the Pharmaceutical and Research and Manufacturers of America alleges that the regulation is based on an erroneous reading of the statutory text and is outside the scope of HHS' rulemaking authority.

The Health Resources and Services Administration, which is part of HHS, released the final rule in July. It went into effect Tuesday.

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Source: Modern Healthcare