PDUFA Reauthorization Law Could Delay Approval Of New Medications, Op-Ed States

Main Category: Pharma Industry / Biotech Industry
Also Included In: Regulatory Affairs / Drug Approvals;  Public Health
Article Date: 11 Oct 2007 - 11:00 PDT

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Legislation to reauthorize the Prescription Drug User Fee Act that President Bush signed last month "could be a death sentence" for "patients with life-threatening illnesses who depend on new drugs making it to market quickly" because of prescription drug safety provisions that could delay the approval of new medications, Gregory Conko, a senior fellow at the Competitive Enterprise Institute, and Erin Wildermuth, a research associate at the institute, write in a Washington Times opinion piece.

According to the authors, lawmakers from both parties have "accused the agency of recklessly speeding drugs to market for the sake of corporate profits and at the expense of patients" in the "wake of recent drug safety scares," and that "attitude prompted many of the changes in the new legislation." However, the authors write, studies conducted by FDA "show the rate of drug withdrawals has remained essentially unchanged over the last 25 years, despite rising and falling approval times during that period," and the "health benefits of faster approval decisions far outweigh the risks associated with the small number of drugs that are eventually withdrawn" (Conko/Wildermuth, Washington Times, 10/10).

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