As Senate and House Committees prepare for hearings next week on the fate of PDUFA - the Prescription Drug User Fee Act - The New England Journal of Medicine this afternoon released three editorials that explore the key issues:

Should industry fund the FDA? To what extent, if any, should industry have a say in how those funds are used? And how should those funds be apportioned? Those writing in were Jerry Avorn of the Harvard Medical School; former FDA commish Mark McClellan; and Brian Strom and Sean Hennessy of the University of Pennsvylvania School of Medicine, both of whom have worked as industry consultants and sat on the FDA Drug Safety Committee.

Avorn: “Last year, the Institute of Medicine and the Government Accountability Office released influential reports concluding that the country’s capacity for identifying drug risks was greatly in need of repair…For a time, it seemed possible that this combination of forces would lead to concrete steps to build a better system for drug approval and adverse-effects surveillance. But the legislative plans that are likely to be enacted do not even come close to achieving that goal.

At a recent meeting on the FDA’s future, all four former FDA commissioners in attendance agreed that the agency should be funded directly through the Treasury, rather than through industry payments. But Congress and the agency’s leadership still don’t get it. The FDA supports reauthorization of PDUFA and proposes that a trivial less than 7 percent of user fees be used to strengthen its capacity for adverse-effects surveillance — an amount far short of what would be needed to repair the inadequate system described by the IOM and GAO.”

McClellan: The proposed 29 percent increase in fees would mean more resources for conducting meetings with drug developers to clarify approval standards and for research on predicting safety problems and patients’ responses to drugs. It would also expand the resources for postmarketing surveillance to $29.3 million, permitting hiring of additional personnel and enhancement of postmarketing capabilities. For fiscal year 2008, total user fees would be nearly $400 million, accounting for more than 40 percent of FDA resources for drug regulation.

The fees are based on the resources required for reviewing drugs and overseeing their use; they are not tied to FDA decisions. The rate at which drugs have been withdrawn from the market has not increased since PDUFA was implemented, and the increase in resources has resulted in important public health benefits, including a reduction in drug review time estimated to have saved 180,000 to 310,000 lives.

Strom and Hennessy: Despite the alarm expressed in the IOM report, the FDA is proposing to devote only $29.3 million — a mere 6.7 percent of the $437.8 million in user-fee revenue anticipated for 2008 — to modernizing and transforming the drug-safety system. It is useful to place this $29.3 million in perspective by considering the $188.5 billion that was spent on prescription drugs in the United States in 2004 and the $11.9 billion spent on pharmaceutical advertising in the same year.

Furthermore, the FDA proposes to spread the $29 million thinly across many divergent activities that are lumped together under the heading of drug safety…It is worrisome that the FDA has not specified how the $29 million will be divided among the myriad tasks on its agenda. And although the activities it proposes are all worthwhile, the agency’s overall plan will fall far short of the goal of modernizing and transforming the drug-safety system and will perpetuate the “troubling imbalance” in resources decried by the IOM.

Further reading…
The New England Journal of Medicine (subscription may be required)

[tags]FDA, PDUFA[/tags]