Initiative so the agency can modernize the way in which the agency deals with new channels of scientific discovery. Dr. Franson likewise stated that reauthorization of PDUFA is absolutely vital.
The FDA’s proposal for PDUFA IV includes programs and funding dedicated to measures aimed at increasing the regulation of postmarket drug safety. Ms. Pendergast stressed that if PDUFA IV is authorized, the resources dedicated to the FDA for drug safety must stay focused on drug safety. She explained how 5 years ago, during authorization of PDUFA III, the FDA received $71 million from industry to pay for large database studies and new drug safety reviewers. However, Congress rescinded much of that money and reprogrammed the small remainder elsewhere in the FDA. As a result, the Office of Drug Safety is no better off than it was 5 years ago.
Most of the panelists attributed some portion of the current drug safety problems and the FDA’s inability to initiate programs to improve the U.S. drug safety system to chronic underfunding and a lack of adequately trained personnel. However, some panelists suggested that the FDA needs to use its existing resources more wisely. Ms. Pendergast stated that the FDA has an obligation to be a steward of the money it receives and to spend that money wisely. Referring to the FDA-commissioned Breckenridge report (Breckenridge Institute, 2006), she remarked that, while the agency received a large sum of money ($25 million) to improve its information technology, it did not spent the money wisely, as the Adverse Event Reporting System (AERS) is no better today than it was many years ago.
Dr. Franson suggested that, given the thousands of people throughout the pharmaceutical industry who are working on the same issues as the FDA, improving the U.S. drug safety system should be a process based on collaboration. The challenge is to coordinate these efforts in a way that will enable shared learning—particularly in precompetitive areas—and enable those involved to utilize resources more effectively by capitalizing on each other’s capabilities. If the current resources of the FDA, industry, and other stakeholders were inventoried, many complementary disciplines (e.g., epidemiology) and best practices would likely be identified. For example, with respect to using potential biomarkers to define risks and benefits in databases, it should be possible to collaborate with large health care organizations that routinely capture at least some of this information. According to Dr. Franson, the need for such coordination is a larger issue than the FDA’s inadequate resources.