Jill Wechsler
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After months of delay, the Senate confirmed Lester Crawford in July as the official head of the Food and Drug Administration.
Crawford's nomination had been put on hold as various legislators sought to pressure FDA to take action on pet issues, such
as drug importing and approval of an over-the-counter version of the "morning-after" pill Plan B. Senate Finance Committee
chairman Charles Grassley (R-Iowa) reflected general concerns about the agency in criticizing Crawford for not tackling drug
safety failures and FDA's "structural, personnel, cultural and scientific problems."
In the end, Grassley and most Senators agreed with the leadership on both sides of the aisle that FDA would be better off
with a permanent chief than without. Now it's up to the new commissioner to demonstrate that FDA decisions will be based on
scientific and medical evidence —and not on pressure from industry or political leaders.
Stability at the Top
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After five years as FDA acting or deputy commissioner, Crawford was able to hit the ground running following Senate confirmation
to the top job. He briefed members of Congress on reports of deaths related to Mifeprex (mifepristone), announced new FDA
leadership [see sidebar on Stability at the Top], and answered pointed questions from members of the House Appropriations
subcommittee that approves FDA's budget.
At that hearing, Rep. Rosa DeLauro (D-Conn) launched a broad critique of Crawford and FDA, 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. All signs point to a rough road ahead as Congress and consumers continue to closely scrutinize FDA initiatives.In his written testimony, Crawford outlined key administrative challenges facing FDA in the coming year. There is expanded
responsibility for ensuring the safety of the nation's food supply and pressure to implement a new user fee program for medical
devices to help bring increasingly complex medical products to market. FDA is in the center of federal efforts to protect
against bioterrorism by spurring development of new vaccines and countermeasures. And much of the agency is moving to a new
White Oak campus in the Maryland suburbs, a costly and disruptive process. In anticipation of this move, the Center for Drug
Evaluation and Research's (CDER's) Office of New Drugs (OND) has reassigned a number of product review divisions, some the
result of creating an Office of Nonprescription Products, which handles applications for switches as well as for new over-the-counter
drugs.
OND also has created a new Office of Oncology Drug Products, which includes drugs, biologics and imaging products to treat
cancer. With the move to White Oak, other biotech therapies will be reassigned to relevant new drug review divisions according
to indication.
Ensuring drug safety
Probably the most important issue on Crawford's agenda is to show that FDA can identify and prevent drug safety problems.
Members of Congress have proposed legislation giving FDA more authority to require label changes and to complete Phase IV
studies. The legislators also want to expand the agency's Office of Drug Safety (ODS) and make it more independent of drug
approval activities in CDER.
FDA is looking to a panel convened by the Institute of Medicine (IOM) to provide a roadmap by next July (2006) for revising
its system for monitoring drug adverse events without expanding FDA operations. At the July meeting of the IOM panel, CDER
officials described the current system for capturing and assessing information on drug risks and benefits during clinical
trials and after a drug comes to market, emphasizing the importance of interaction between staffers in ODS and OND. Paul Seligman,
director of CDER's Office of Pharmacoepidemiology and Statistical Science (OPPS), also acknowledged that additional resources
could help FDA gain more valuable information on drug utilization and safety from real-world resources.
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