November 20, 2015

(Washington D.C.)— Stakeholders at today’s Health and Human Services (HHS) Pharmaceutical Forum should examine ways to increase competition and eliminate delays in drug approvals that would in turn lower costs and improve patient access, the Pharmaceutical Care Management Association (PCMA) said.

“The best way to reduce prescription drug costs is to expedite approval of brand and generic drug competitors,” said PCMA President and CEO Mark Merritt.

The Food and Drug Administration’s (FDA) approval of the first biosimilar drug in the United States was a positive first step toward increasing competition and in turn lowering biologic drug costs for consumers, employers, government programs, and others.

The FDA and Congress can further enhance competition in the pharmaceutical marketplace by:

• Expediting Approval of Competing Brand Drugs. Currently, the FDA focuses on expediting approvals for only certain types of new drugs, bypassing other products that would offer benefits comparable to existing medicines and thus bolster competition among branded drugs.

• Eliminating Delays in Generic Drug Approvals. The median Abbreviated New Drug Application (ANDA) approval time is currently 42 months, meaning that it takes the FDA, on average, more than three times longer to approve an ANDA than to approve a standard New Drug Application (NDA) or Biologic License Application (BLA) and more than five times longer than it takes to approve a priority NDA/BLA.