PDUFA Reauthorization Law Could Delay Approval Of New Medications

Armen Hareyan's picture

Approval Of New Medications


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

Accordingto the authors, lawmakers from both parties have "accused the agency ofrecklessly speeding drugs to market for the sake of corporate profitsand at the expense of patients" in the "wake of recent drug safetyscares," and that "attitude prompted many of the changes in the newlegislation."

However, the authors write, studies conducted by FDA"show the rate of drug withdrawals has remained essentially unchangedover the last 25 years, despite rising and falling approval timesduring that period," and the "health benefits of faster approvaldecisions far outweigh the risks associated with the small number ofdrugs that are eventually withdrawn" (Conko/Wildermuth, Washington Times, 10/10).

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