PDUFA: A Weird Name Worth Learning

PDUFA: A Weird Name Worth Learning

04.18.12 | By Kate Connors

Today has been a big day for reauthorization of the Prescription Drug User Fee Act - which, as a reminder, is legislation that must pass by the end of September at the latest.

To that end, PhRMA Senior Vice President for Scientific and Regulatory Affairs Dr. David E. Wheadon testified at a hearing of the House Energy & Commerce Subcommittee today about the importance of timely reauthorization. In his testimony, he emphasized precisely what PDUFA means to the patients that we serve: "Since the passage of the original PDUFA in 1992, the U.S. has become the world leader in bringing new medicines to patients first." He also discussed how the benefit of PDUFA also extends to the economy, as our companies play a large role in America's economy. For example, the FDA performance goals letter would help increase predictability in the FDA review process, which is one factor in continued investment in the discovery and development of new medicines.

But we aren't the only ones who recognize the importance of PDUFA. In a blog post on Ezra Klein's Wonkblog today, Washington Post reporter Sarah Kliff quotes Dr. Wheadon calling PDUFA "'a great success for patients.'" I'd draw your attention to the headline of the piece: "PDUFA: The most important health policy you haven't heard of."

Also today, legislation was introduced in both the House and the Senate that would provide permanent reauthorization of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. As we've noted before, these have been incredibly successful programs, and permanent reauthorization would really strengthen them by providing more certainty to the companies embarking on years-long pediatric studies. Our statement is available here.

Follow Kate on Twitter @KateAtPhRMA.

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