LinkPad: PDUFA Passes House Committee

This week, the House Energy and Commerce Committee unanimously approved the FDA Reform Act, which will reauthorize the Prescription Drug User Fee Act (PDUFA).  As I have often discussed on LillyPad , PDUFA is an important legislation that ensures patients have access to new and innovative medicines faster.  This week's LinkPad highlights what is being said about the past successes of PDUFA and its latest legislative installment.

  • In an article for the Washington Times, Sally C. Pipes writes, "It's vital that Congress reauthorize the PDUFA with all deliberate speed. The lives and health of millions of American patients depends on it."
  • According to an article by Forbes contributor, Doug Schoen, "Despite having received little attention from the media, the Senate may vote on one of the most crucial and serious pieces of health policy [last] week." Schoen outlines the history of PDUFA and its importance for providing patients speedy access to safe medicines.
  • The Hill's Sam Baker outlines the desired outcome for PDUFA markups from multiple stakeholders, and emphasizes the quick movement Congress is taking on this must-pass legislation.
  • A report released by the Government Accountability Office (GAO) found the US Food and Drug Administration (FDA) to be meeting its performance goals for reviewing applications under the terms of the Prescription Drug User Fee Act (PDUFA).