November 17, 2014
(Washington, D.C.)— The Food and Drug Administration (FDA) can enhance competition in the pharmaceutical marketplace, helping lower prescription drug costs, according to a new white paper, “Considerations of the FDA’s Impact on Competition in the Drug Industry,” from Matrix Global Advisors (MGA) and released by the Pharmaceutical Care Management Association (PCMA).
“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 white paper highlights policies to improve competition among prescription drugs, including:
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 36 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 six times longer than it takes to approve a priority NDA/BLA.
Finalizing the Creation of a Biosimilar Pathway. The FDA’s delay in issuing final guidance for biosimilar manufacturers has thwarted the development of a U.S. biosimilar industry, preventing the savings that competition would generate. In addition, the possibility that the agency will require unique naming for biosimilars could impede prescribing and utilization of potential biosimilar products.
Adequate Funding for the FDA. The President’s fiscal year 2015 budget request to Congress for drug-related services is an increase of just under 3 percent from fiscal year 2014. Higher funding levels for the FDA, appropriated through Congress, would allow the agency to enact policies that increase competition.
“The FDA plays a pivotal role in determining how much competition exists in the prescription drug marketplace,” said Alex Brill, CEO of MGA and author of the white paper. “How the FDA uses its authority to promote competition and innovation can impact both the availability of new cures but also the cost of prescription drugs.”