On Aug. 23, the AAMC commented on House Energy and Commerce Committee Chair Cathy McMorris Rodgers’ (R-Wash.) discussion draft legislation intended to address drug shortages. The proposal, which Rodgers stated aims to “address the root causes of shortages with a multifaceted approach,” would increase market flexibility for generic drug manufacturers, impose additional transparency requirements on group purchasing organizations, and require the Food and Drug Administration to exercise existing reporting requirement authorities. Addressing drug shortages and strengthening the pharmaceutical supply chain is an area of focus for Rodgers, who, earlier this year, issued a joint request for information on this topic with Senate Finance Committee Ranking Member Mike Crapo (R-Idaho) [refer to Washington Highlights, July 14].
In its comments, the AAMC expressed its opposition to Rodgers’ proposal to exempt certain generic, sterile injectable drugs from the 340B Drug Pricing Program. The letter argued that because there is “no reliable evidence” that the 340B program contributes to shortages, such a policy would “have little to no effect on the prevalence or severity of shortages.” The AAMC also underscored concerns that this policy would reduce 340B covered entities’ savings, thereby limiting access to care for low-income patients, while establishing a “worrying precedent” by carving out certain types of drugs from the program.
The AAMC also commented on Rodgers’ proposal to eliminate or cap inflationary penalties for certain generic drugs under the Medicaid Drug Rebate Program, citing concerns that such a policy would “result in significant drug price increases, which states, the federal government, and hospitals will ultimately be forced to shoulder.”