Press Release

Statement on PDUFA - 2011

PhRMA April 26, 2013

Washington, D.C. (October 24, 2011) — Pharmaceutical Research and Manufacturers of America (PhRMA) Senior Vice President for Scientific and Regulatory Affairs Dr. David E. Wheadon issued the following statement today on reauthorization of the Prescription Drug User Fee Act (PDUFA):


“Reauthorization of the Prescription Drug User Fee Act provides Congress with an opportunity to provide patients with access to innovative medicines in a more timely fashion; reinforce the Food and Drug Administration’s (FDA) high standards for safety, efficacy and quality; and advance the scientific bases for FDA’s regulatory oversight.


“PhRMA supports the goals of PDUFA and continues to believe that the PDUFA-V performance goals letter, as drafted, provides FDA with the needed resources and tools to meet these goals, while enhancing the timeliness, completeness, and efficiency of the drug review process.


“Since 1992, PDUFA has helped FDA bring needed new medicines to the tens of millions of Americans who rely on them, while protecting the public health by assuring the safety and efficacy of these products.


“Because of this, PhRMA encourages Congress to reauthorize PDUFA in an expedient fashion. We further hope that the bill ultimately passed by Congress will include the constructive, carefully negotiated performance goals letter, with minimal additional provisions that could create unintended burdens on the regulatory process or delay the legislative process. It is imperative that this important legislation be approved in a timely manner so that the agency can proceed with its essential function.”

Dr. Wheadon’s testimony in full is available here.

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