Instead, the picture is bleak: Safety concerns about Merck's Vioxx (rofecoxib) and antidepressants have expanded to include a broad range of therapies. Newspapers are questioning whether the Prescription Drug User Fee Act has corrupted the drug approval process. Prosecutors and plaintiffs' lawyers are hunting for evidence that companies knowingly promoted unsafe products. On Capitol Hill, the powerful Senate Finance Committee is taking a renewed interest in drug regulatory issues, as Congressional leaders plan investigations and hearings on industry practices and the "lax" FDA. And this month, state attorneys general will meet to hash out strategies for tightening the screws on drug pricing and promotions.
Here are some areas where pharma can expect to feel the heat.Who Controls Safety? There is increasing support for the creation of a drug safety office independent of the drug approval process. Experts say already-approved drugs should be reviewed again to ensure that Phase IV studies have been completed and to examine emerging safety signals. Both the Institute of Medicine and the Government Accountability Office will be issuing reports on the effectiveness of FDA's postmarket review system. They are expected to recommend increased spending on safety surveillance and product testing. A likely funding source is the user fee program, which comes up for renewal in two years.
Improving Information The Vioxx debacle is providing fodder for critics of DTC advertising. An FDA summary of the agency's own research indicates that consumers don't really like drug ads and don't find them helpful in making healthcare decisions. In recent months, FDA has criticized industry promotional activities in a flurry of warning letters, and the agency is under pressure to scrutinize DTC advertising more closely to ensure that marketers fully address safety and risk issues. FDA's long-awaited final rule revising professional labeling for drugs is slated to emerge "soon," and will help shape changes in the format and content of ads and materials providing drug information.
Safety concerns will also intensify efforts to expand public access to clinical trial listings and study results. Congress is weighing legislation to mandate broader disclosure of both negative and positive research outcomes, even though industry has proposed a voluntary listing program. In a related move, the National Institutes of Health (NIH) is completing an initiative to allow public access to the results of all NIH-funded research. Medical journal publishers oppose the NIH policy and are countering with a plan to post hundreds of journal articles on a public website.
Innovation Takes a Back Seat Until a few weeks ago, the top spot on FDA's priority list was the agency's effort to lay out pathways to speed more new drugs to market. Now the turmoil about safety is raising fears of tighter drug approval policies and curbs on R&D. Agency officials recently acknowledged some slowdown in the process of turning the March 2004 Critical Path report into new models for drug research and development. Lack of funding may hamstring FDA collaborative efforts with industry and private research organizations.
Multiple Challenges In addition to these hot topics, industry and FDA face a broad range of health care issues in coming months:
Vaccine shortages. The unexpected shutdown of Chiron's Liverpool (UK) flu vaccine manufacturing facility in October and the resulting shortage of flu vaccine for this winter continues to focus public attention on vaccine research and regulation. Some members of Congress are blaming FDA for failing to enforce manufacturing standards or to recognize earlier the severity of the problems at Chiron's plant. Prospects are dim that Chiron will regain its license in time to get back into production by March, so policy makers will be looking for ways to encourage manufacturers to enter the US flu vaccine market.
FDA recently gave emergency approval to GlaxoSmithKline's vaccine, prompting GSK and other firms to weigh possibilities for expanding sales to the United States. For the long term, HHS may offer grants to support research on new vaccine manufacturing methods while Congress weighs tax incentives for new plant construction, government guarantees to buy back unused vaccine doses, and legislation to reduce the threat of liability charges against vaccine manufacturers.