Latest Changes and Challenges at FDA

Oct 01, 2012

Jill Wechsler
Everyone loves to criticize the Food and Drug Administration. The agency has become a pawn in the national election debate, as Republicans pledge reforms to overcome roadblocks to US medical product innovation. Yet, consumer advocates charge that too-quick reviews permit unsafe medicines to reach patients. FDA staffers are struggling to establish new user fee programs and to implement a host of provisions authorized by the FDA Safety & Innovation Act (FDASIA), with no added resources to do so. One response is to reorganize to better manage growing drug regulatory operations. Another strategy advocated by FDA commissioner Margaret Hamburg is to support regulatory science, which can open new pathways for bringing innovative medical products to market efficiently and effectively. But FDA won't have resources to support innovation if it takes a big hit from the federal budget crisis.

Unsafe at any speed?

Despite pressure on FDA from patient groups and industry to moderate testing requirements and accelerate reviews of new drugs, particularly treatments for seriously ill patients, critics continue to complain that "fast track," "priority review" and "accelerated approval" policies permit harmful products to reach the market. The latest entry to the debate comes from Thomas Moore of the Institute for Safe Medicine Practice and Curt Furburg, professor at Wake Forest School of Medicine. They cite safety concerns about drugs recently approved under expeditious policies in an article in the Journal of the American Medical Association (Sept. 5, 2012), but also downplay concomitant postapproval safeguards. Their solution is to require longer clinical trials and more extensive analysis to ensure that benefits of new therapies outweigh risks.

That's contrary to a main theme of FDASIA, which supports FDA expedited review for breakthrough drugs, acknowledging patients' willingness to understand and accept more risk. More stridently, the GOP platform highlights the need for FDA reform, noting "a lack of predictability, consistency, transparency, and efficiency" at the agency, which "is driving innovation overseas." GOP leaders pledge to ensure that FDA "no longer wastes US taxpayer and innovators' resources because of bureaucratic red tape and legal uncertainty." The platform provides no specifics for reaching these goals. Yet this "government is bad" mentality has a certain "menacing quality," notes consultant Steven Grossman (

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