PDUFA V Supported by Government, Industry, Patients

This article at Genetic Engineering and Biotechnology News (GEN) offers further insight into how PDUFA V will improve the FDA's approval process and help it deliver innovative medicines to patients in a timely manner.

According to the article, "PDUFA V holds more potential than PDUFA IV ever did for the partnership long envisioned between government, industry, and supporters within the patient community." By increasing communication throughout the drug development process, setting standard timelines for drug review, and allocating additional financial resources to hiring FDA staff members, PDUFA V will establish a transparent, predictable review process that benefits patients, medical professionals, and the biopharmaceutical development sector.

The article goes on to say that some consumer advocates felt that PDUFA V doesn't do enough to incorporate patients' viewpoints, but PDUFA V does work to incorporate patient perspectives into the drug review process. It charges the FDA with developing "a decision framework that will more systematically allow FDA to take into account input from patients and consumers and more appropriately determine the benefits and risks in the therapeutic context." This includes the institution of a structured risk and benefit assessment program and the development of an standardized process for risk evaluation and mitigation strategies.

During the last PDUFA reauthorization (PDUFA IV, in 2007), the FDA was burdened with additional regulations that seriously hindered its ability to meet review goals, almost doubling the review times for priority drugs. In order to prevent similar delays in the future, PDUFA V must pass Congress cleanly, without the addition of unnecessary legislative mandates.

As the article states, the goal of PDUFA V reauthorization is "to fulfill what FDA calls the spirit of the original PDUFA authorized in 1992, which was articulated most recently by CDER director Janet Woodcock, M.D., in testimony July 7 to the House: 'speeding patient access to drugs shown to be safe and effective for the indicated uses.'" We at the Campaign for Modern Medicines agree wholeheartedly with this goal, and we urge you to stand with us as we ask Congress to pass a clean PDUFA in 2012.