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The agency's 2008 budget fails to keep up with expanding programs, added safety concerns.
Twenty years of increased assignments and declining budgets have changed the Food and Drug Administration from the world's gold standard for drug regulation into an agency with "serious scientific deficiencies" that cannot meet its regulatory responsibilities, according to the agency's advisory Science Board. In a scathing analysis issued last December (2007), the panel described how FDA "will flounder and ultimately fail" without strong scientific research programs and updated information infrastructure. "While the world of drug discovery and development has undergone revolutionary change—shifting from cellular to molecular and gene-based approaches—FDA's evaluation methods have remained largely unchanged over the last half century," according to "FDA Science and Mission at Risk" [http://www.fda.gov/OHRMS/dockets/AC/07/briefing/2007-4329b_02_01_FDA%20Report%20on%20Science%20and%20Technology.pdf].
The main culprit is inadequate funding. FDA lacks the staff and resources to support regulatory functions and keep up with scientific advances in systems biology, nanotechnology, medical imaging, robotics, cell-based products, regenerative medicine, and combination products, explained Gail Cassell, Eli Lilly vice president and chair of the Science Board subcommittee issuing the report. FDA needs the expertise to understand these developments and their role in ensuring the safety of medical products and the nation's food supply.
Fast-expanding user fees have made up for some of FDA's funding deficit, but increased reliance on industry payments, which will total $522 million in 2008—almost one fourth of FDA's total budget—has created inequities within the agency. This is particularly true for the Center for Drug Evaluation and Research (CDER), where almost half of its $682.8 million 2008 budget comes from user fees. An analysis by panel member and prominent attorney Peter Barton Hutt reveals that any FDA budget increases over the past 20 years have been lost to inflation. The agency has gained only 700 appropriated staffers during this period, even though its work was expanded by hundreds of statutes, executive orders, and other mandates.
Failure to Launch: New Drug Approvals Decline
A key FDA need is an information technology system able to process and integrate vast amounts of scientific information. The FDA IT infrastructure is "obsolete, unstable, and lacks sufficient controls to ensure continuity of operations," reported Dale Nordenberg of PriceWaterhouseCoopers, who served on the panel. FDA spends about $200 million on IT, he explained, but requires at least another $200 million to be able to assess reams of clinical trial data and to track thousands of manufacturing and research sites around the world.
Without adequate staff and IT resources, FDA cannot implement cutting-edge approaches to modeling, risk assessment, and data analysis so important to fulfilling its regulatory mission, Cassell noted. The panel recommends naming a chief scientific officer at FDA to oversee expanded scientific programs and extramural collaborations, including a new Incubator for Innovation in Regulatory and Information Science (IIRIS) to support innovation across all FDA-regulated industries.
This and other specifics on how scientific research supports FDA assessment of clinical trials, manufacturing facilities, and product applications attracted interest on Capitol Hill. Senate Health Committee Chairman Edward Kennedy (D-MA) termed the analysis a "wake-up call" to provide FDA with the resources needed to do its job, and Rep. Henry Waxman (D-CA) urged administration leaders to tackle these problems.
Only a few days later, though, Congress approved a long-delayed omnibus budget bill for fiscal year 2008 (began October 1, 2007) that boosted FDA's total budget to $2.2 billion—$1.7 billion without user fees. In light of heavy spending cuts across the federal government, FDA did well to receive any increase at all. But this year's budget falls far short of the $2 billion annual appropriation sought by agency advocates.
Moreover, Congress utilizes the appropriation process to specify how FDA should spend its money and to micromanage agency policies. Most of CDER's increase is earmarked for drug safety and generic drug regulation. There is $7.5 million for FDA's Critical Path Initiative (CPI), but that is much less than initially proposed by the Senate, and about one third of it has to be disbursed to universities and nonprofits doing CPI research.
The legislators further instruct the agency to work with pharmacy and patient groups to improve the MedGuide program, reflecting pharmacists' fears of being overwhelmed by a growing volume of patient leaflets on specific drugs. And FDA has to produce a long list of studies and reports on everything from Ketek safety to microbial resistance. The final legislation omits an earlier provision to expand drug reimportation, but still requires FDA to analyze how well it oversees foreign manufacturers of active drug ingredients.
In an unexpected move, Congress provides an added $4 million to oversee direct-to-consumer drug advertising instead of implementing a new user fee program established by the FDA Amendments Act (FDAAA). Industry was willing to pay an extra $6.5 million in fees to support more timely and predictable assessments of drug TV commercials, but some legislators objected to the arrangement and slipped the change into the final bill.
This reversal reflects ongoing concerns on Capitol Hill about pharmaceutical company influence on FDA policies. Congress reminds FDA in the budget bill to reduce the number of advisory committee members with conflicts-of-interest. The legislation also undermines the launch of the Reagan-Udall Foundation, which was authorized by FDAAA, 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, put a hold on funding the new organization for fear that it would permit drug companies to shape FDA actions related to drug safety.
While FDA officials hope to assuage DeLauro's concerns, the rift is likely to slow down Reagan-Udall initiatives, such as helping to establish a new active surveillance system for drugs, also encouraged by FDAAA. Former FDA commissioner Mark McClellan, named chair of Reagan-Udall, is a leading advocate of using health system databases and IT systems to detect and analyze drug safety signals earlier and faster. Establishing the surveillance system is no easy undertaking and will require new data standards and collaborative efforts, tasks suitable for this public–private foundation.
Dropping the DTC user fees is an unusual step for Congress. Legislators generally find it convenient to tap this source of revenue to fund FDA and are proposing more new fees to bolster the agency's ability to monitor the soaring volume of food and drugs imported from overseas. In the past year, FDA faced crises involving contaminated pet food and toothpaste from China and medicines laced with diethylene glycol that took lives in developing countries.
The FDA's field force is sorely depleted and requires added resources to inspect the growing volume of overseas manufacturers and research sites. A recent proposal is for FDA to establish permanent overseas inspection offices in both India and China. FDA signed a memoranda of agreement with China in December that encourages safety certification of exported drugs and information sharing related to inspections.
The hope is that increased public focus on unsafe food and drug imports may prompt Congress and the Bush administration to boost FDA funding. A more likely scenario, however, is that the policymakers will instruct FDA to do more with the limited financial resources it already has.