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FDA could lose 251 employees under the administration's proposed 2006 budget. The agency will try to do more with less through risk-management practices, but important tasks will fall by the wayside.
The controversy surrounding the appointment of Lester Crawford to head FDA reflects the difficulty of finding anyone with the scientific and political credentials to fill the post. And there are concerns about the agency, as Senate Finance Committee chairman Charles Grassley (R-IA) demonstrated when he declared that Crawford had failed to tackle FDA's "structural, personnel, cultural, and scientific problems."
But by late July, most members of the Senate, including Grassley, agreed that FDA is better off with a permanent chief than without. And with five years as acting or deputy commissioner, Crawford seemed to deserve the job. But he failed to win unanimous approval from the Senate, a sign of a tough road ahead as Congress and consumers continue to scrutinize FDA activities and initiatives.
Crawford's challenge is to show that FDA decisions will be based on scientific and medical evidence—not political or industry pressure. He'll have ample opportunity to do so. In the days following his confirmation, the new commissioner briefed members of Congress on deaths related to Mifeprex (mifepristone), announced changes in FDA leadership (see "Stability at the Top"), and answered pointed questions from the House Appropriations subcommittee, which approves FDA's budget.
Stability at the Top
At that hearing, Rep. Rosa DeLauro (D-CT) pressed Crawford to support legislative changes in FDA operations, citing flu vaccine shortages due to "inept oversight," delayed withdrawals of drugs such as Vioxx, and failure to enforce an animal-feed ban to protect against mad cow disease. In his written testimony, Crawford outlined FDA's key administrative challenges for the coming year. He noted difficulties implementing a new user-fee program for medical devices and spurring development of new vaccines and countermeasures to protect against bioterrorism. And the agency is beginning a massive move to a new White Oak campus in the Maryland suburbs, a costly and disruptive process.
Another monumental task for FDA is to ensure the safety of the nation's food supply. FDA receives some 27,000 notifications each day about incoming food shipments but can inspect only a handful. Crawford acknowledged that the agency could lose 251 employees under the administration's proposed 2006 budget. The agency will try to do more with less through risk-based management practices that focus resources on FDA's most vital oversight responsibilities, but many important tasks inevitably will fall by the wayside.
Shifts at CDER
Probably the most important item on Crawford's agenda is to show that FDA can identify, prevent, and manage drug safety problems. Members of Congress have proposed legislation authorizing FDA to require drug label changes that reflect safety concerns and to force companies to complete promised Phase IV studies. Some legislators also want to expand the Office of Drug Safety (ODS) and make it more independent of drug-approval activities in the Center for Drug Evaluation and Research (CDER).
FDA officials look to a panel convened by the Institute of Medicine (IOM) to provide a roadmap for revising how it monitors adverse events. At the panel's July meeting, CDER officials described FDA's system for capturing and assessing information on drug risks and benefits, emphasizing the importance of interaction between ODS and the Office of New Drugs (OND). Paul Seligman, who oversees ODS as director of CDER's Office of Pharmacoepidemiology and Statistical Science (OPPS), acknowledged that additional resources could help FDA gain more information on drug utilization and safety.
Crawford was reluctant to openly seek more money or expanded oversight authority at the July appropriations hearing. He said he is "open to discussion" of such proposals, but that FDA's Drug Safety Oversight Board and Drug Watch safety information Web site can best address public demands for more drug safety information.
A related challenge for Crawford is to counter fears in the research community that drug safety concerns may prompt FDA to require longer, larger clinical studies. At the July IOM committee meeting, OND director John Jenkins described the "unintended consequences" of such a slow-down: A demand for larger trials could prompt sponsors to cancel drug development programs altogether, and longer studies could delay access to potentially valuable treatments. But members of Congress on both sides of the aisle don't buy concerns about development costs—especially when they see pharma companies enjoying apparently huge profits.
Meanwhile, continued focus on drug safety has put FDA's Critical Path initiative on the back burner. After issuing an initial report more than a year ago, FDA is still promising to publish a list of opportunities for collaborative research that could spur drug innovation. Crawford regularly mentions the importance of pursuing critical-path initiatives and now is in the position to do so.
Proposals to expand FDA oversight authority or restructure agency operations will gain a broader hearing in coming months as Congress prepares to tackle reauthorization of the Prescription Drug User Fee Act (PDUFA), which expires in 2007. FDA, manufacturers, and interest groups are gearing up for the debate, which will require Crawford and his staff to articulate agency positions on a host of hot issues:
Drug importing Crawford says FDA cannot ensure the safety and quality of products from abroad, echoing the administration's stance—and infuriating members of Congress. Many legislators consider importing a good way to give American consumers access to lower-cost prescription drugs and will continue to press for its legalization.
Generic biologics With patents on some $10-billion worth of branded biotech therapies expiring over the next three years, FDA is under pressure to describe a legal and regulatory pathway for generic biopharmaceuticals. At the House appropriations hearing, Crawford said that improved technology may facilitate characterization of complex molecules and that FDA would issue a report this fall on follow-on proteins. Crawford's challenge is to retain incentives for developing new biotech therapies while permitting approval of generics; legislation to clarify FDA legal authority in this area is expected.
Drug marketing Crawford has raised concerns about DTC advertising, as have leading Republicans and Democrats and health care professionals. FDA has been issuing more warning letters on DTC ads and recently launched a process to review its DTC advertising policy. PhRMA has issued guidelines to curb more objectionable advertising practices (see "Heading Off the DTC Regulators" ) but Congress will press for legislation if the voluntary approach fails to address public complaints.
Next year will mark FDA's 100th anniversary, and Crawford is eyeing opportunities to highlight the agency's achievements. The celebration will coincide with FDA's relocation to White Oak, a move that Crawford believes heralds a new chapter in FDA's history. For the first time in decades, multiple agency operations will be housed in close proximity, making it easier to interact and collaborate. For patients and policy makers to share this enthusiasm, the new commissioner will have to convince them that FDA is up to the task of keeping dangerous medical products out of patients' hands, while supporting continued biomedical innovation.
Jill Wechsler is Pharmaceutical Executive's Washington correspondent.