Public Health Alert Newspaper - by Susan Williams - Review Panel Releases “Report Card” on FDA Practices Part 2

Review Panel Releases “Report Card” on FDA Practices Part 2

by Susan Williams

In response to growing public concern, the FDA asked the Institute of Medicine in 2004 to assess the U.S. drug safety system and make recommendations for improvements. That 200-plus-page report, "The Future of Drug Safety: Promoting and Protecting the Health of the Public", was just released this September and contains plenty of suggestions for the FDA, although many of them would require approval from Congress.

The review panel, consisting of 15 experts drawn from various academic and professional organizations, was unanimous in endorsing the recommendations. Several of the recommendations have previously been requested by drug safety advocates for many years, but have been resisted.

Some of the suggestions include:

	Newly approved drugs would carry a special symbol on the label, such as the black triangle required in Britain, warning consumers that their safety is still in question.
	New drugs would only be approved for five years, at which point the FDA would again review their safety.
	A ban on direct consumer advertising of newly approved drugs during this probationary period.
	The FDA needs to be given the power to impose fines and requirements on drug manufacturers.
	Manufacturers should be required to register all clinical trials they sponsor in a government-run database to facilitate public access to drug safety information.
	Manufacturers should be required to produce outcomes of all studies, not just those published in medical journals, which are more likely to show only positive results.
	To reduce turnover and political interference, the FDA commissioner should be appointed to a fixed six-year term.

The panel also suggested that a "substantial majority" of FDA advisory panel members not have any industry ties, and recommended a large boost in funding and staffing for the agency.

Although most of the panel’s recommendations were focused around drug review, safety surveillance, and related activities, the panel also considered potential contributions of the pharmaceutical industry, the academic research enterprise, Congress, the health care delivery system, patients and the public. During its research, the committee found that the perception and credibility of the FDA and of the pharmaceutical industry has been compromised. "FDA's credibility is its most crucial asset, and recent concerns about the independence of advisory committee members . . . have cast a shadow on the trustworthiness of the scientific advice received by the agency”, the report said. The committee also reported that the FDA and the pharmaceutical industry do not consistently demonstrate accountability to the public.

While most interested parties -- the agency, consumer organizations, Congress, professional societies, health care entities -- appear to agree on the need for certain improvements in the system, the pharmaceutical industry questioned some of the conclusions of the report.

"It would be a mistake to accept the notion that the FDA drug safety system is seriously flawed," said Caroline Loew, senior vice president of the Pharmaceutical Research and Manufacturers of America. "After all, fewer than 3 percent of approved prescription drugs have been withdrawn from the American market for safety reasons over the last 20 years."

Scott Lassman, senior assistant general counsel for the drug industry group, said the industry is open to suggestions, but the FDA already has enough authority to act after drugs are approved. "The trade group also opposes mandatory registration of clinical trials because that would force companies to reveal trade secrets to competitors”, Lassman said. "Manufacturers also oppose restrictions on advertising, as advertisements help educate patients about problems and treatments."