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Public Statements

Prescription Drug User Fee Amendments of 2007

Floor Speech

Location: Washington, DC




Mr. SPECTER. Madam President, the Food and Drug Administration Revitalization Act is an important step toward protecting American consumers and patients and ensuring the safety of prescription drugs. To increase the safety and efficacy of prescription drug approval, I will offer an amendment to establish the National Centers of Pharmaceutical Innovation. These Centers, in consultation with the Food and Drug Administration, FDA, Commissioner, will modernize medical product development and enhance product safety.

I am very concerned about long delays and the safety of bringing new drugs to patients. The FDA has been faced with the withdrawal of prescription drugs from the market due to concerns about increased health risks. This situation illustrates the difficulty in achieving the right balance in investigating new drugs that, while intended to help patients, can also come with very serious risks. Furthermore, such incidents could lead to the erosion of public confidence in the safety of medicines developed by drug companies. Drug companies spend enormous sums of money to test potential new candidate medicines. Not only is the process of developing and testing a new drug costly, it is lengthy as well. As a result of delays in the clinical trials process, there are fewer drug discoveries each passing year, ultimately hindering our Nation's competitiveness in this field.

According to Ernst R. Berndt, Ph.D., Adrian H. B. Gottschalk, S.M., Matthew W. Strobeck, Ph.D., Massachusetts Institute of Technology, MIT, Sloan School of Management, ``scientific advances and enhanced [research and development] efforts, the number of average annual new drug applications, NDAs, and new biologic license applications, BLAs, approved by the U.S. Food and Drug Administration has been smaller after 2000 than in the mid-1990s. Moreover, recent estimates suggest the average costs of bringing a new medicine to market have increased sharply to between $800 million and $1.7 billion, with the lower estimate being 2 1/2 times higher than similar inflation-adjusted estimates published a dozen years earlier.'' Clearly, there is great need to improve the methods and science that are used to approve prescription drugs.

I am further concerned that new technologies, including genomics, proteomics, and bioinformatics are not being fully incorporated into the drug approval process. Using these new technologies as part of the clinical drug approval process has the potential to substantially reduce costs and the time needed to develop and test new drugs. Additionally, we must improve the workforce available to pharmaceutical companies, which is not well trained in the modern tools needed for sophisticated drug development. The FDA does not have a structured research program to bridge this knowledge and workforce gap and has few extramural research activities in place to tap the expertise available in our Nation's university health programs.

This amendment will establish the National Centers for Pharmaceutical Innovation to improve the development and testing of new drugs so that they make it to market more quickly and remain there. Up to five centers will be operated by universities in partnership with the FDA to develop methods to utilize new technology to improve the drug approval system. They will also expand the quality and number of professionals trained to work in this field. The centers will introduce new technologies to improve the manufacture of pharmaceutical and biotechnology products.

I believe these centers can provide a significant part of the solution to this complex problem. These centers will be established from qualified universities that have graduate training programs with extensive experience in the development and evaluation of medicines; and proficiencies in pharmaceutical and biotechnology science and engineering. It is the expectation that the work completed by these centers and the FDA would lead to an increased number of drugs brought to market by industry, at a decreased cost. Another effect will be an enormous gain to the public's health, while decreasing the chance of unintentional harm and costs of medical care.

The National Centers for Pharmaceutical Innovation hold a promising solution to the problems in drug discovery and safety facing our Nation today. I encourage my colleagues to support this important amendment.

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