PDUFA-V Builds Platform for New Era of Regulatory Science

PDUFA-V Builds Platform for New Era of Regulatory Science

10.01.12 | By John Castellani

In the parlance of corporate mergers, "Day 1" is a critical moment of transition. While not without challenges, Day 1 often brings a sense of excitement, promising growth platforms and long-term opportunities. When it comes to regulatory policy, this marks the biopharmaceutical research sector's Day 1.

Today, October 1, is the official kick-off for the implementation of PDUFA-V. FDA now is tasked with operationalizing the many elements outlined in the most recent reauthorization of the Prescription Drug User Fee Act, as well as selected provisions in the Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law in July.

PDUFA-V has the potential to be a landmark agreement. It refocuses the prescription drug user fee program on its original intent - fostering timely patient access to new medicines - while establishing a new system-wide approach to regulatory science. If implemented successfully, PDUFA-V will:

  • enable more timely patient access to safe and effective new medicines through enhanced scientific communications in the drug review process;
  • provide FDA with the resources necessary to advance regulatory science and help enhance drug development and review;
  • support the development of a framework to facilitate evaluations of the benefits and risks of new medicines and integrate patient perspectives in the review process; and
  • further strengthen FDA's already robust focus on patient safety.

The development of these provisions reflects thousands of hours of hard work and collaborative thinking from dedicated professionals within the biopharmaceutical sector, the FDA, the patient community and Congress.

But it's just the beginning. PhRMA is committed to working with the agency, the Biotechnology Industry Organization, patient groups and other health stakeholders to help ensure a strong implementation outcome and a seamless transition to the negotiation of PDUFA-VI.

As I conveyed during a recent appearance at the National Press Club, this reauthorization of PDUFA is a great example of long-term, forward-looking regulatory policy that will help support medical innovation and bring new life-saving medicines to patients. At a time when policy discussions so often focus heavily on short-term implications, PDUFA-V is a refreshing and promising step forward.

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