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