On Wednesday, April 18, 2012, the House Energy and Commerce Committee, Subcommittee on Health, held the seventh hearing on the FDA since February and the latest in a series of hearings on the reauthorization of the Prescription Drug User Fee Act (PDUFA). The two-panel hearing discussed some of the specific points of the most recent PDUFA draft submitted by the House in anticipation of markup next week as well as some overall concerns regarding drug shortages. Supply chain safety and 510k medical device approvals played a prominent role in questions fielded by the first panel. Dr. Jeffrey Shuren of CDRH made it a point to state in his opening testimony that it is important at this point in the process for Congress to refrain from adding policy points to the PDUFA agreement to which the FDA and industry did not agree.
Janet Woodcock, CDER, FDA; Jeffrey Shuren, CDRH, FDA
Chairman Pitts opened by asking Dr. Woodcock whether measuring FDA performance goals on a division level would be beneficial to identify areas that need the most improvement. Dr. Woodcock said that you can’t attach productivity to a particular disease area based on only tangible metrics – just because a disease area, like neurology, is not approving the same drugs as the oncology division does not mean they are not making huge strides. Ranking Member Pallone asked about an inclusion in the House PDUFA discussion draft that requires the FDA report to Congress on certain drug approvals. Dr. Woodcock stated that is a provision not agreed to by the FDA and industry, nor were the resources necessary to execute that mandate calculated into the final user fee numbers.
The 510K approval process was of particular interest to Rep. Burgess, who asked Dr. Shuren if the FDA has allowed products they know to be unsafe to come to market under 510K. While Dr. Shuren did not explicitly state this to be fact, he acknowledged they have had concerns about some products that showed a substantial equivalence to devices already on the market. The FDA has tried to counter this using labeling, but since they have no data to support their concerns about the device, it would be difficult to keep the product from being used. Additionally, mandatory recalls of devices can take several years. Dr. Shuren said this has happened with a “handful” of devices, and Rep. Burgess requested Dr. Shuren report back to the committee on all devices that fall into that category.
The Chairman opened the hearing to full committee members, and Rep. Engel brought up the potential benefits of public private partnerships and singled out the Critical Path Institute. Dr. Woodcock stated a number of essential products, like biomarkers, are speeding through the research and development process faster than they would otherwise. She praised the possibilities in developing clinical data standards and the use of health information technology in helping FDA and investigators in collecting clinical trial data.
Other topics of discussion in panel one included overseas manufacturing inspections, drug shortage issues, track and trace programs, changing the FDA mission statement to reflect economic growth and job creation, illegal online pharmacies, Primatine Mist, the GAIN Act for antibiotic development, and repackaging of drugs by hospitals into different dosages. These topics have been covered at length in previous hearings.
David E. Wheadon, senior vice president of scientific and regulatory affairs, Pharmaceutical Research and Manufacturers of America; Sara Radcliffe, executive vice president of health, Biotechnology Industry Organization; David Gaugh, vice president of regulatory sciences, Generic Pharmaceutical Association; Joseph A. Levitt, partner, Hogan Lovells US LLP, representing Advanced Medical Technology Association; Allan Coukell, director, Medical Programs, Pew Health Group, The Pew Charitable Trusts
In their opening statements, the participants on the second panel all supported a timely reauthorization of PDUFA and the creation of generic and biosimilar user fee acts, underscoring certain areas of benefit such as the inclusion of total time goals and policy areas like supporting the GAIN Act and earlier discussion of risk management strategies.
During the question and answer period, panelists were asked about the development of drugs for rare pediatric diseases, the benefits of the GAIN Act, and conflict of interest rules. Rep. Burgess directed the question of conflict of interest to Ms. Sara Radcliffe of BIO, and she stated she would like to return to the pre-2007 conflict of interest rules.
The issue of Investigational Device Exemptions (IDE) was raised by Rep. Pitts as well as Rep. Burgess. Mr. Levitt responded by saying IDEs are under a higher level of scrutiny by the FDA than they used to be, and it appears now that FDA will only an IDE to a study if they think the study will likely result in a new drug application.
The question and answer period of the second panel was truncated due to votes.