Regulatory Beat: Crawford Faces Policy and Program Challenges - FDA's top priority is to restore public confidence in review and regulatory programs for biomedical products. - BioPharm International

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Regulatory Beat: Crawford Faces Policy and Program Challenges
FDA's top priority is to restore public confidence in review and regulatory programs for biomedical products.


BioPharm International



Jill Wechsler
The Senate confirmed Lester Crawford in July as the official head of the Food and Drug Administration (FDA). Crawford's nomination had been put on hold as various legislators pressured FDA to approve an over-the-counter version of the "morning-after" pill, Plan B, and to support broader drug importing. Senate Finance Committee chairman Charles Grassley (R-IA) reflected broader concerns about FDA in criticizing Crawford for not tackling drug safety failures and FDA's "structural, personnel, cultural, and scientific problems." In the end, Grassley and most members of the Senate agreed that FDA would be better off with a permanent chief than without but failed to give the new commissioner unanimous approval. Crawford faces a rough road ahead as Congress and consumers continue to closely scrutinize FDA activities and initiatives.

The situation makes it critical for Crawford to demonstrate that FDA decisions will be based on scientific and medical evidence — and not on pressure from industry or political leaders. With five years experience as acting or deputy FDA commissioner, Crawford moved quickly following Senate confirmation to brief members of Congress on reports of deaths related to Mifeprex (mifepristone), announce new FDA leadership [see Stability at the Top], and answer pointed questions from members of the House Appropriations subcommittee, who are responsible for approving FDA's budget.

At that hearing in July, Rep. Rosa DeLauro (D-CT) reflected the fairly negative opinion of 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 key challenges facing FDA in the coming year. The agency has fast-growing responsibilities for ensuring the safety of the nation's food supply, as well as difficulties regulating a growing number of complex medical devices. He also noted FDA's central role in protecting against bioterrorism by spurring development and ensuring production of new vaccines and countermeasures. And finally, the agency's move to its new White Oak campus in the Maryland suburbs promises to be a costly and disruptive process.

These tasks will be difficult to address in the face of a real budget squeeze on FDA. The situation prompts Crawford to talk more about "risk- based management practices," which means targeting inspections and oversight to higher-risk products and activities, an approach that applies particularly to drug and biotech manufacturing. Crawford acknowledges that in the current "environment of fiscal restraint," FDA field investigators should spend more time and resources inspecting "highly complex or high-risk drug products and processes." The unstated promise is that FDA will reduce inspections and oversight for manufacturers that adopt new technologies capable of assuring quality drug production.

ENSURING DRUG SAFETY


Stability at the Top
The biggest challenge for the new commissioner is to demonstrate that FDA can identify and prevent drug safety problems. Members of Congress have proposed legislation to give FDA authority to require label changes and to complete Phase 4 studies. The legislators also want to expand the agency's Office of Drug Safety and make it more independent of drug approval activities in the Center for Drug Evaluation and Research (CDER) (see Regulatory Beat, August 2005). FDA officials look to a panel convened by the Institute of Medicine (IOM) to provide a roadmap by next July (2006) for revising its monitoring system for drug-adverse events without adding new layers to FDA regulatory operations. At the House Appropriations hearing, Crawford said he was "open to discussion" of such proposals, but has refused to back any specific legislation.


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