Limited Resources Challenge Regulators - The much needed modernization of the agency's IT systems and inspection capabilities will likely fall prey to budget shortfalls. - BioPharm International

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Limited Resources Challenge Regulators
The much needed modernization of the agency's IT systems and inspection capabilities will likely fall prey to budget shortfalls.


BioPharm International
Volume 21, Issue 2


Jill Wechsler
Twenty years of increasing assignments and declining budgets has changed the US Food and Drug Administration from the world's gold standard for drug regulation into a "debilitated, under-performing organization," according to the agency's advisory Science Board. In a scathing analysis issued last December (2007), the panel described how FDA suffers from "serious scientific deficiencies" and cannot meet its regulatory responsibilities.1

The main culprit is inadequate funding, according to the Science Board subcommittee that prepared the report. FDA lacks the staff and resources needed to support regulatory functions and to keep up with scientific discoveries important to ensure the safety of medical and food products. Fast-expanding user fees have made up for some of the deficit, but increased reliance on industry payments has created inequities in FDA. An analysis by panel member and attorney Peter Barton Hutt reveals that any budget increases over the last 20 years have been lost to inflation. FDA has gained only 700 appropriated staffers during this period, even though its work was expanded by hundreds of statutes, executive orders, and other mandates.

A key FDA need is an information technology (IT) system that is able to process and integrate vast amounts of scientific information. FDA's IT budget runs about $200 million, but it would require at least another $200 million to be able to assess reams of clinical trial data and track thousands of manufacturing sites around the world. Senate Health Committee Chairman Edward Kennedy (D-MA) termed the analysis a "wake-up call" to provide FDA with adequate resources to do its job, and Rep. Henry Waxman (D-CA) called on FDA and administration leaders to tackle these problems.

FLAT FUNDING

Only a few days after the meeting, however, Congress approved long-delayed federal government funding legislation for fiscal year 2008 (which began on October 1, 2007) that boosted FDA's total budget funding to $2.2 billion—$1.7 billion without user fees. In view of heavy spending cuts across the federal government, FDA did well to receive any budget increase at all. Agency advocates seek to boost FDA appropriations to $2 billion in five years, but this year's budget falls short of this goal. Much of the $145-million increase in appropriations, moreover, will support food safety programs, with little left for other regulatory initiatives.

The Center for Drug Evaluation and Research (CDER) has a $682.8 million budget for 2008, almost half of which ($356 million) comes from user fees. Much of CDER's increase will go to drug safety activities and the rest to regulate generic drugs, direct-to-consumer advertising, and FDA's Critical Path initiative. The Center for Biologics Evaluation and Research (CBER) will have a $237-million budget, including $81 million from user fees. Its $12-million gain supports pandemic influenza preparedness and other popular initiatives.

UNDUE INFLUENCE?

As usual, Congress uses the appropriation process to micromanage FDA policies. The legislation seeks an assessment of FDA's MedGuide program for riskier therapies and instructs the agency to produce studies and reports on everything from Ketek safety to microbial resistance. Several provisions reflect ongoing concerns on Capitol Hill about pharmaceutical and biotech industry influence on FDA policies. Congress reminds FDA to reduce the number of advisory committee members with conflicts-of-interest, and undermines the launch of the Reagan-Udall Foundation by stipulating that FDA cannot use any appropriated funds to support this new organization. Rep. Rosa DeLauro (D-CT), chair of the House Appropriations subcommittee that oversees FDA, has objected that Reagan-Udall provides an avenue for manufacturers to shape FDA safety initiatives.

While FDA officials hope to assuage DeLauro's concerns, the rift may interfere with efforts to help establish an active surveillance system for drugs. Former FDA Commissioner Mark McClellan, recently named to chair Reagan-Udall, is a leading advocate of using health system databases and advanced IT systems to detect and analyze drug safety signals earlier and faster to prevent safety problems and facilitate new drug development. Establishing such a system is no easy task and will require new data standards and collaborative efforts, a task appropriate for Reagan-Udall.


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