Drug development and regulation could be affected by limited resources at FDA

Key Points

In the report, the board stated that FDA "will flounder and ultimately fail" without strong scientific research programs and an 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 the report.

The panel that presented the report to FDA stated that the largest problem facing FDA is inadequate funding. According to Gail H. Cassell, PhD, vice president of scientific affairs at Eli Lilly and Co, and chair of the Science and Technology subcommittee, FDA lacks the staff and resources necessary to support regulatory functions and to keep up with scientific advances in systems biology, nanotechnology, medical imaging, robotics, cell-based products, regenerative medicine, and combination products. Dr Cassell said FDA needs the expertise to understand these developments and their potential effects on the safety of medical products.

According to the report, in addition to a larger budget and more staff members, FDA is also in need of an information technology (IT) system that is able to process and integrate vast amounts of scientific information. FDA's current IT infrastructure is "obsolete, unstable, and lacks sufficient controls to ensure continuity of operations," said Dale Nordenberg, MD, managing director, Healthcare Industry Advisory, PricewaterhouseCoopers, who served on the panel.

Dr Nordenberg said that although FDA currently spends approximately $200 million on IT, the agency needs at least another $200 million to be able to assess an extensive amount of clinical trial data and to track thousands of manufacturing and clinical research sites around the world. Dr Cassell said that without an adequate staff and IT resources, FDA cannot implement the cutting-edge approaches to modeling, risk assessment, and data analysis that are essential to fulfilling the agency's regulatory mission.

The panel recommended 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 help support innovation across all FDA-regulated industries.

Senate Health Committee chairman Edward Kennedy (D–Mass) termed the report a "wake-up call" to provide FDA with the resources the agency needs to do its job. Rep Henry Waxman (D–Calif) urged administration leaders to tackle the problems described in the report.

FLAT FUNDING

Less than a week after the Science Board presented these findings, Congress approved a long-delayed omnibus budget bill for fiscal year 2008 (which began October 1, 2007) that boosted FDA's total budget to $2.2 billion ($1.7 billion before user fees). Despite the panel's recommendations for greater funding and additional resources, this year's budget falls far short of the increases sought by agency advocates.

Congress is responsible for allocating how the money included in the FDA budget is spent. Most of the increase in the CDER budget is earmarked for drug safety and generic drug regulation. FDA's Critical Path Initiative (CPI) was allotted $7.5 million, much less than the amount initially proposed by the Senate. Approximately one-third of this funding is designated for universities and nonprofit organizations conducting CPI research.

The legislators also assigned funding to help improve FDA's Medication Guide program. They also requested that the agency compile a comprehensive list of studies and reports that address a wide variety of subjects, including the safety of specific drugs and microbial resistance. The final legislation omits an earlier provision to expand drug reimportation, but still requires FDA to analyze how well the agency oversees foreign manufacturing of active drug ingredients.

UNDUE INFLUENCE?

In an unexpected move, Congress provided an additional $4 million for oversight of direct-to-consumer (DTC) drug advertising instead of implementing a new user fee program that was established by the FDA Amendments Act (FDAAA). This reversal reflects ongoing concerns on Capitol Hill about pharmaceutical company influence on FDA policies. Congress also stated in the budget bill that FDA must reduce the number of advisory committee members who have conflicts of interest.

This legislation also impedes the launch of the Reagan-Udall Foundation, which was authorized by the FDAAA, by stipulating that FDA cannot use any appropriated funds to support this new organization. Rep Rosa DeLauro (D–Conn), chair of the House Appropriations subcommittee that oversees FDA, put a hold on funding the new organization because of concerns that the foundation could be influenced by the drug companies, which in turn could influence FDA actions related to drug safety. FDA officials hope to assuage Ms DeLauro's concerns, but in the meantime, progress will likely be halted on carrying out Reagan-Udall initiatives, such as establishing a new, active surveillance system for drugs. Before these legislative actions occurred, former FDA commissioner Mark McClellan, MD, PhD, was named as chairman of the Reagan-Udall Foundation. Dr McClellan is a leading advocate of using health-system databases and advanced IT systems to improve the detection and analysis of drug safety signals. Establishing the surveillance system will likely be a challenge that will require new data standards and collaborative efforts.

IMPORTS AND SAFETY

Eliminating the FDAAA-established user fees program is considered by many FDA advocates to be an unusual step for Congress. The legislators frequently rely on DTC user fees to fund FDA, and escalating concerns about the increasing volume of drugs imported from overseas is prompting calls from policymakers for even more new fees.

It appears that FDA's field force is depleted and requires additional resources to inspect the growing volume of overseas manufacturing and clinical research sites. The hope of FDA advocates is that increased public focus on unsafe drug imports may prompt Congress and the Bush administration to boost FDA funding. The fear is that policymakers will instruct FDA to do more with its already limited resources.

SOURCES

FDA science and mission at risk: Report of the Subcommittee on Science and Technology. Prepared for FDA Science Board. http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_01_FDA%20report%20on%20science%20and%20technology.pdf. Published November 2007. Accessed January 21, 2008.

Ms Wechsler is a Washington-based reporter specializing in federal and state healthcare issues.