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).

For more information about PDUFA, visit the Campaign for Modern Medicines or follow @modernmeds on Twitter.

Comments

ALS patients support this!!!
Very interesting legislation they're considering, indeed. It will be interesting to see if they move fast enough to approve this before the SCOTUS rules on the health care reform case(s) before the end of June. Looks like it will open the door up for many more generic drug application reviewers, which can only be a good thing in getting those evaluated - assuming there isn't confusion about what the standards are in the reviewing itself (which may or may not be a part of the very HCR law enacted to create a pathway for more generic approvals). We'll see. Thanks for this newsworthy post!