Generic Drug Settlements, AMP Calculation Provisions Approved by House
On July 1, 2010, the House of Representatives approved an amendment to a supplemental appropriations bill (H.R. 4899) that includes two provisions impacting prescription drugs. First, the House amendment includes a provision to block certain so-called “pay-for-delay” agreements in patent litigation settlements in which a brand-name pharmaceutical company compensates a generic pharmaceutical company for delays in generic entry. Second, the amendment would clarify the definition of average manufacturer price (AMP) – and thus the application of the Medicaid drug rebate statute -- for inhalation, infusion, and injectable drugs that are not dispensed through a retail community pharmacy. Note that the Senate still must approve the amendment before it can be enacted into law.
