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The year's first PDUFA hearing took place today, and there is definitely a lot to talk about! The members of the Health Subcommittee on the House Energy and Commerce Committee spent several hours listening and talking to the two witness panels: the first consisted of FDA Commissioner Dr. Margaret Hamburg, while the second was compiled of representatives from industry and patient advocacy organizations. While the conversation was wide-ranging, the overall consensus was that PDUFA brings essential benefits to public health and to America's competitiveness in the global pharmaceutical market, and that timely reauthorization of PDUFA is in everyone's best interest.
Throughout the hearing, multiple committee members and witnesses noted the importance of reauthorizing PDUFA in a timely manner. Subcommittee Chairman Joe Pitts stated that he and Energy and Commerce Committee Chairman Upton feel that it is in the best interest of the American people for Congress to reauthorize PDUFA V by the end of June. In her testimony, Commissioner Hamburg pointed out that if FDA is "to sustain and build on our record of accomplishments, it is critical that the reauthorization occur seamlessly without any gap between the expiration of the old law and the enactment of PDUFA V." We agree, and we urge Congress to reauthorize PDUFA before July 4th to ensure that patients' access to lifesaving and life-enhancing new medicines is not delayed.
The Committee also focused on the fact that PDUFA V has important repercussions on the United States' position as the global leader in biomedical innovation. Since PDUFA's enactment, the FDA has been able to review new drugs more quickly than other regulatory bodies such as the European Medicines Agency, speeding new medicines to American patients without compromising their safety. Of the 35 new drugs approved by the FDA last year, almost 70% were approved by the FDA before any other drug review body in the world. A consistent and predictable regulatory process is key to encouraging biopharmaceutical innovation and ensuring that the United States is able to maintain its global competitiveness and support American jobs.
Both committee members and witnesses expressed strong support for reauthorizing the Pharmaceutical Research Equity Act (PREA) and the Best Pharmaceuticals for Children Act (BPCA), acknowledging their great contributions to pediatric medicine. Like PDUFA, PREA and BPCA would encourage consistency at the FDA, providing certainty and predictability during both the research and discovery phase and the regulatory process. Since the European Union has already made similar regulations permanent, it's important the United States do the same in order to provide American children with the same innovative treatments, and remain on an equal playing field with other nations.
As we've previously stated, we believe Congress should pass a PDUFA that is closely based on the technical letter already endorsed by FDA, patients, and industry. It promotes consistency, predictability, and transparency in the FDA regulatory process, which increases patient access to medicines and allows the U.S. to remain competitive in the global market. Adding legislation unrelated to the FDA's mission would only hinder the Agency's ability to promptly and safely review new medicines. Rep. Waxman addressed this issue in his opening statement, when he said that "it would be irresponsible to allow this legislation to become a vehicle for the wish lists of members seeking to move their own controversial bills." We concur: keeping PDUFA clean is the best way to ensure that patients continue to receive timely access to breakthrough medicines and that the U.S. remains the global leader in discovering these new treatments and cures. We think that Dan Wheadon of PhRMA put it well when he said:
PhRMA encourages Congress to reauthorize PDUFA in a timely manner based on the negotiated PDUFA-V performance goals and to minimize the inclusion of additional provisions that may have the unintended consequence of distracting from the Act's original intent - to provide patients with faster access to innovative medicines, to preserve and strengthen FDA's high standards for safety, efficacy and quality, and to advance the scientific basis for the Agency's regulatory oversight.
Thank you for engaging with us on Twitter and Facebook during the hearing! We were pleased to see such animated discussion about PDUFA, and will be back with another post on participation later this week. In the meantime, we hope you'll continue to work with us as we urge Congress to pass a clean PDUFA as soon as possible.
