On July 7, 2011, the House Energy and Commerce Committee Subcommittee on Health held a hearing to discuss the upcoming reauthorization of PDUFA legislation and talk about pertinent issues surrounding the Food and Drug Administration (FDA). The hearing convened two expert panels: Panel I featured Dr. Janet Woodcock, Director, Center for Drug Evaluation and Research, Food and Drug Administration (FDA). Panel II consisted of Friends of Cancer Research (Friends) Chair and Founder Dr. Ellen Sigal, as well as Paul J. Hastings, president and CEO OncoMed Pharmaceuticals Inc.; Jonathan Leff, managing director, Warburg Pincus; Marc Boutin, executive vice president and COO, National Health Council; and Allan Coukell, director of medical programs, Pew Health Group.
After opening remarks by the Chairs and Ranking Member, the first panel commenced with the statement of Dr. Janet Woodcock, Director, Center for Drug Evaluation and Research, FDA. In her testimony, Dr. Woodcock outlined the positive impact of PDUFA in the years since its enactment in 1992, current challenges to the program, and drug safety at the FDA. She called for the upcoming reauthorization of PDUFA to be held with high degree of transparency and increased stakeholder involvement.
During an extensive question and answer period, Dr. Woodcock was quizzed on a range of topics including innovation, outsourcing of jobs and money to countries in the European Union and Asia, the predictability of the drug approval process, drug safety, and budgetary issues. Although she expressed optimism in light of an increase of drug approvals in 2011, Woodcock remains concerned about a lag in applications coming through the door, stating, “It is no exaggeration to say that the industry is in crisis.”
Panel II began with statements discussing the reforms brought about by the original PDUFA, recognizing the need to strengthen the FDA, and using the reauthorization of PDUFA to reexamine areas of FDA policy. Mr. Hastings and Mr. Leff both reiterated the need to revise and strengthen the FDA mission statement, with Mr. Boutin underscoring the need for stakeholders to come “back to the table” in order to see continuing benefits from PDUFA.
In her statement, Dr. Sigal stressed the need to get safe and effective treatments to patients quickly and highlighted the findings of a recent study conducted by Friends and published in Health Affairs that showed on average, the FDA approves oncology drugs faster than its European counterpart the European Medicines Agency (EMA). Later in the hearing, Dr. Sigal was asked by Rep. Bilbray about what appeared to be a shrinking gap between U.S. and European approvals in the later years examined in the study. Dr. Sigal noted that since the study was completed, the U.S. has approved three additional oncology drugs not yet approved by the EMA. She emphasized the science of these drugs is complex and it is not a matter of which agency approves drugs the fastest, but the safety of those drugs for patients.
Throughout the second panel, participants fielded questions about venture capital investment in biomedical research and development, job creation in the scientific sector, and challenges facing companies going through the drug approval process. The hearing concluded with a short discussion regarding conflict of interest rules and the need for a review of the current rule structure.
