On Feb 21, 2007, 40 experts, and four times as many reporters and students, assembled at the George Washington University School of Public Health for a meeting organised by Scientific Knowledge and Public Policy (SKAPP). The attendees listened to four former commissioners from the US Food and Drug Administration (FDA) dissect their experiences—Donald Kennedy, Frank Young, David Kessler, and Jane Henney. What is wrong with the FDA, and how can it be fixed? Kessler confessed that this meeting was the first time he had talked publicly about his stint at the FDA. Among the stories, the consensus was that FDA drug regulation had come to reflect the needs and demands of the drug industry.Other concerns were expressed by the commissioners as well:
The former commissioners worried about the Prescription Drug User-Fee Act (PDUFA). The worries became more real when one of the scholars described the detrimental consequences of speedier drug approvals and the increased likelihood that such approvals would be flawed. To comply with the user-fee law, the FDA has shifted appropriated funds into the drug-approval process, diminishing all resources available for other mandated functions across the whole agency. Surely shortchanged in this process is the epidemiology of adverse reactions in already approved drugs.I guess these drug industry influences should not come as a surprise. Given the 93-1 vote of approval that the Senate has already garnered from both sides of the aisle, and the fact that the pharmaceutical manufacturers have had one of the largest political action committee contributions to our members of Congress, it seems unlikely that anything is going to stop this train.
The strongest consensus emerged about the need for a very sizeable increase in resources. Despite money from drug makers, allocated in secret negotiations with the FDA—“a corporatist model”—far larger appropriation is needed, not only for the activities mandated by law but also to increase the science capacity and communicate the public-health mission more effectively. Participants were envious about how the NIH's constituency of researchers and patients' advocates had delivered on a plan to double the Institutes' budget. Could the new FDA Alliance do the same?
Kaisernetwork.org's Webcast of the Conference