Barton: Bipartisan Efforts Help Improve FDA Bills
U.S. Rep. Joe Barton, R-Texas, ranking member of the House Energy and Commerce Committee, issued the following statement today as part of a Health Subcommittee markup on the Prescription Drug User Fee Act Reauthorization, Medical Device User Fee and Modernization Act Reauthorization, drug safety, and certain pediatric pharmaceutical and device legislation:
"I want to thank you, Mr. Chairman, and the full committee chairman, Mr. Dingell, for the good faith, bipartisan effort that has been made in the last several weeks to develop the bipartisan compromise that sits here before us today on many of these bills. There are some sections on some bills that can still be improved and we reserve the right of the minority to offer amendments at the appropriate time. But by and large, I think we have a good package of bills and I think we can expect a smooth markup today.
"The Prescription Drug User Fee Act and the Medical Device User Fee and Modernization Act need to be reauthorized in a timely manner so that we avoid the FDA having to send reduction in force notices to their employees.
"Since the passage of PDUFA, the number of full-time equivalent staff devoted to the new drug review process has doubled, from over 1200 in 1992 to 2500 in 2004. More than half of that increase in staff has been funded by the user fees.
"Drug review times have decreased as a result of the increase in staff. In 1993, it took the agency an average of 22 months. In fiscal year 2004, it dropped to below 11 months. In that time period, the FDA has approved over 1000 new drug applications providing patients with access to new therapies that improve and save lives.
"The language that is before us today would dramatically increase the user fees imposed on companies over the negotiated agreements. The negotiated agreement that was transmitted to the Congress already provides for a large increase in fees. Under the negotiated agreement, a new drug application fee would rise from about $800,000 to $1.1 million. Under the draft bill, that same application would increase to about $1.5 million. For many smaller companies, that may only have a few products approved, such a large increase could be a significant barrier to market entry. The steep increase in these fees are breathtaking and for some of the smaller companies, may exceed the taxes that are being paid by these companies on an annual basis. We many have an amendment to offer that would reduce those increases back to the stakeholder agreement that has been agreed to by the Bush Administration.
"We also need to reauthorize the Medical Device User Fee this summer, to ensure that there is a continuation of that program. We have a good agreement that has been negotiated in good faith by the stakeholders. Under the first authorization several years ago, we witnessed large fluctuations in the amount of the per application fee. This volatility made it difficult for companies to develop business plans to bring new products to market. The agreement before us today would add two new types of user fees, and by doing so should lend more predictability to the annual increases in the application fees. This is an important point that will help strengthen the user fee program.
"I am concerned that the draft bill before us on MDUFA does not contain the reforms that we had hoped it would have on third party facility inspection. The agency and the industry agree this is necessary to agree before we choose this option. A robust third party inspection program would allow facilities to be inspected more frequently, by allowing the agency to better target resources to areas of concern. I must note that the agreement on third party inspection still preserves the ability of the agency to conduct an ad hoc inspection at its discretion.
"The Pediatric Rule and the incentives to provide for more clinical testing in pediatric populations must also be reauthorized. The Best Pharmaceuticals for Children Act has been tremendous success in ensuring the drugs developed for adults have had testing done in pediatric populations. I support the reauthorization of both programs. However, I am concerned with the impact that certain proposed modifications will have on the program. It is important that we be careful that our actions here do not end up reducing the number of studies being conducted in pediatric populations.
"We also are addressing the issue of pediatric medical devices. We have heard at our hearings that there is unmet need for medical devices for pediatric populations. The paradigm used for pediatric drugs does not translate to devices and we must account for the differences both the device market as well as the limited patient populations of children in need of these devices. This is important issue where I believe agreement can be reached, but we must not pass a bill for the sake of saying we passed legislation. We should ensure that the legislation that does pass this House will ultimately lead to our intended goal: the development of medical devices for pediatric populations.
"We will also be considering legislation on issues surrounding drug safety. There have been a few highly publicized drugs that have lead for some to make the conclusion that more authorities are need for the Food and Drug Administration. I believe it is necessary step to provide the Secretary with the authority to compel companies to conduct a post market clinical trial. I also believe we should allow the FDA to determine what safety information should be included on a drug's label. I was worried that that the provisions of the discussion draft were too broad in scope and could have lead to reduction to patient access for needed medications. Although we must ensure that the FDA has the proper authorities to monitor the safety of drugs, we should not swing the pendulum too far so that patients in need of medications will suffer.
"I am pleased that through discussions over the past week, legislation has been developed that can improve our drug safety without being overly burdensome or endanger patient access to drugs. There may be instances where a Risk Evaluation and Mitigation Strategy is a necessary component of ensuring that a drug is used properly and the safety of the drug is monitored more stringently. The legislation before us today will provide the secretary with the discretion to compel a manufacturer to institute a REMS when it is necessary and provides flexibility to tailor a REMS to the specific risks associated with a drug. With such discretion and flexibility, the secretary can better focus its resources to protect the public health.
"I am concerned about the level and the scope of the new civil monetary penalties incorporated in the drug safety bill. The legislative language creating the penalties goes well beyond violating a REMS or failure to make a label change or conduct a post market clinical trial. This language would apply to any violation of the Food, Drug, and Cosmetic Act, no matter how minor. A company would be subjected to a penalty of up to $20 million for failing to sweep the floor of a facility. This is ludicrous and it is punitive. We should have penalties that are commensurate with the violative action. Additionally, these will be penalties decided in an administrative proceeding, not a court of law. A company who faces a penalty of up to $100 million is not even afforded the full protection of the judicial system.
"Although there are some outstanding disagreements, I thank Chairman Pallone and Chairman Dingell for their willingness to work through some of the issues that were brought up at the hearings we have had. I think it is possible to reach a bipartisan House agreement, and thanks to the willingness of the majority we are well on our way.
"Thank you Mr. Chairman and I yield back the balance of my time."