Following this week’s U.S. Senate Special Committee on Aging's hearing on "Sudden Price Spikes in Off-Patent Prescription Drugs," Pharmaceutical Care Management Association (PCMA) President and CEO Mark Merritt called for this nation’s policymakers to make generic drugs more accessible.
"The single best way to reduce prescription drug prices is to introduce competition in the marketplace, Merrit said. “However, competition is lacking among older, off-patent drugs that treat small populations. This leads to unlimited pricing power and higher profits for certain drug manufacturers."
In order to counter “seniority rules,” Merrit argued that the Food and Drug Administration (FDA) must begin to approve generic drugs at a much faster rate than the three to four years that it currently takes to review new generic pharmaceutical drugs.
A possible solution suggested included creating an Abbreviated New Drug Application approval fast track and incentive program for generic drugs that will be competing with off-patent brands. Merrit would also like to see a list of off-patent drugs that do not currently face any competition.
As of now, the FDA has a backlog of nearly 4,000 new generic pharmaceutical drug applications.
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