New MedPAC Report: Abbreviated Biogenerics Pathway ‘Urgently Needed’
March 10, 2008
PCMA: Competition Necessary to Drive Down Costs
(Washington, DC)— A new Medicare Payment Advisory Committee (MedPAC) report that says “having an abbreviated biogenerics approval process is urgently needed because many of the most innovative and costly products entering the market are biologics” signals the growing support for creating a clear regulatory pathway for biogenerics, the Pharmaceutical Care Management Association (PCMA) said today.
“Introducing much-needed competition into the biologics space in order to lower costs and increase access is now seen in Washington as a ‘common-sense’ health care solution,” said PCMA President and CEO Mark Merritt. “The latest MedPAC report reinforces the need for policymakers to develop a clear regulatory pathway for biogenerics.”
Unlike conventional drugs, there is no established regulatory process where biogenerics can be approved by the FDA. Last year, PCMA was joined by a number of influential consumer, employer, and insurer groups who endorsed the “Access to Life Saving Medicine Act of 2007,” bipartisan legislation that seeks to create a clear regulatory pathway for biogenerics.
PCMA is the national association representing America’s pharmacy benefit managers (PBMs), which administer prescription drug plans for more than 210 million Americans with health coverage provided through Fortune 500 employers, health insurance plans, labor unions, and Medicare Part D.
Charles Coté 202-207-3605