PCMA Response to FDA Commissioner Scott Gottlieb’s Remarks on the Drug Supply Chain

(Washington, D.C.) — The Pharmaceutical Care Management Association (PCMA) released the following statement on today’s remarks by Food and Drug Administration Commissioner Scott Gottlieb, specifically those appearing to reference drug manufacturer abuses of risk evaluation and mitigation strategies (REMS) that block generic competition:

“Contrary to today’s remarks, pharmacy benefit managers (PBMs) have long been strong supporters of bipartisan legislation that would prevent brand drug manufacturer abuses of risk evaluation and mitigation strategies (REMS) that block generic competition. Allowing generic and biosimilar drugs to get to market more quickly will reduce overall drug costs.

A broad group of other stakeholders support this legislation, including the Association for Accessible Medicines, the Academy of Managed Care Pharmacy, Public Citizen, and Blue Cross Blue Shield Association.

Regarding point-of-sale rebates, PBMs offer these programs in the commercial market. However, requiring Medicare Part D plans to use these savings to lower out-of-pocket costs instead of premiums and other expenses would increase premiums for all seniors, and help only 10 percent who take certain drugs. The Administration’s proposed budget found this proposal would cost taxpayers $42 billion.”