PCMA President Mark Merritt advocates for greater off-patent drug competition

In response to the U.S. Senate Special Committee on Aging's hearing on "Sudden Price Spikes in Off-Patent Prescription Drugs" held earlier this month, Pharmaceutical Care Management Association (PCMA) President and CEO Mark Merritt asked policymakers to take an initiative toward making generic drugs easier to produce and distribute.

"The single best way to reduce prescription drug prices is to introduce competition in the marketplace, Merritt 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."

Merritt argues that In order to nullify this “seniority rules” pricing power situation, the Food and Drug Administration (FDA) must take strides to lessen the approval process time of new generic drugs. Currently, it takes the FDA three to four years to review and approve new generic pharmaceutical drugs.

Additionally, the PCMA president suggests that policymakers create and efficiently execute an Abbreviated New Drug Application approval fast track and incentive program for generic drugs that will be competing with off-patent brands. Merritt would 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.