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
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 (
Jill Wechsler is the Washington Editor for Pharmaceutical Executive and writes about federal government policies and programs that affect the pharmaceutical industry. Her monthly Washington Report discusses legislative proposals, FDA initiatives and actions by other government agencies, including Medicare pharmacy benefit proposals, federal
investigations related to pharmaceutical company marketing, debate over DTC advertising, generic drug competition, over-the-counter initiatives, among
other topics. She has written for PE for more than ten years and also covers Washington for other Advanstar publications, including Pharmaceutical Technology, Applied Clinical Trials, BioPharm, Managed Healthcare Executive and Formulary. Prior to that she reported on
government policies and a wide range of topics for business and consumer publications.
Articles by Jill Wechsler