Report says FDA not up to scratch

Sep 25 2006

According to a new report by the Institute of Medicine (IOM), despite the debacle following the drug Vioxx which was withdrawn from the market two years ago, few lessons have been learned and the Food and Drug Administration (FDA) in the U.S. still lacks the power and resources to adequately monitor the safety of newly-approved drugs.

The report by a panel of experts says the situation is unsatisfactory and the FDA needs more staff, funding and power over the drug industry, in order to better police the safety of new medications and respond effectively when something goes wrong after they reach the market.

The 2004 withdrawal of the arthritis drug Vioxx, has resulted in a plethora of legal cases and has highlighted a "dysfunctional" FDA structure which the report says fails at times to protect the public's health.

The report called 'The Future of Drug Safety' says the FDA's reputation has been tarnished by what appears to be a lack of transparency and accountability and a tardiness when it comes to dealing with non- compliant drug companies regarding requests for new warning labels or post-approval studies.

The report suggests that drug labels carry a "new drug" symbol during the first two years on the market to warn consumers that less is known about risks and benefits.

The panel have called for an urgently needed "cultural change" to support a stronger, more systematic and more credible approach to drug safety.

The current acting FDA Commissioner Andrew von Eschenbach, while saying the FDA had improved its oversight of drugs on the market, has agreed that more needs to be done and says new measures will be announced shortly.

The panel also recommends a ban on advertising aimed at consumers during the initial two-year period and is advising that five years following a drug's launch, the FDA conducts a formal review of all available information about the product's risks and benefits.

The FDA itself initiated the report following wide criticism that the organisation was too slow in responding to reports of side effects from various drugs, in particular Vioxx, which was eventually withdrawn because of a link to heart attacks and strokes.

The IOM panel says claims that FDA officials had trouble managing scientific disagreements and downplayed some concerns by safety reviewers, were found to be substantiated, while the problematic handling of internal conflicts "have played an important role in damaging the credibility" of the agency.

Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research, although agreeing that there were "some cultural issues" that should be addressed, insists the agency nevertheless still makes sound, science-based decisions.

The report has recommended a six-year term, rather than an open-ended appointment, to enhance stability and says that at least 60 percent of FDA advisory panels should be free of "significant financial involvement" with companies that may be affected by the decisions.

The Institute of Medicine is an independent organization that advises the government on scientific matters.