Healthy Skepticism Library item: 13089

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Publication type: news

Wilde Mathews A.
FDA Unveils Plan to Boost Oversight FDA Unveils Plan to Boost Oversight
The Wall Street Journal 2008 Feb 26
http://online.wsj.com/article/SB120405750657094407.html?mod=rss_Health

Full text:

The Food and Drug Administration unveiled a new effort to bolster its oversight of drugs after they’re on the market, in the agency’s latest response to years of criticism about its handling of medication safety issues.

Among other changes, the plan, dubbed “Safety First,” involves creating a new database listing possible side effects of drugs, along with clear schedules for following up on questions about them. Also, the FDA plans to make changes to its procedures for making certain regulatory decisions, particularly those based on emerging safety worries, though the new moves don’t go as far as some critics have advocated.

“What we’re doing is to create an integrated approach … that isn’t going to perpetuate problems of the past but really try to embrace what have to be solutions of the future,” said Andrew von Eschenbach, the FDA’s commissioner.

The plan was announced to FDA staff in an email today, and the agency is expected to testify about it tomorrow on Capitol Hill.

The FDA plans to grant some new powers to the office that focuses largely on the safety of marketed drugs, known as the Office of Surveillance and Epidemiology. Republican Sen. Chuck Grassley of Iowa, among others, has raised concerns about the agency’s current decision-making process, because regulatory power over drugs once they are approved rests primarily with the same drug-review divisions that decided to approve them for marketing in the first place.

The new moves stop short of divorcing the two functions. The safety office will not get the ultimate power to sign off on label changes or recommendations to remove a drug from the market.

“I think we really believe that … the team that has been in charge of drug development, that knows the drug best of all, really needs to be in charge,” said an FDA official, who spoke on condition of anonymity. The group that reviews drugs before they go on the market has an understanding of their benefits, which must be weighed against emerging potential risks, the official said.

The agency will have multidisciplinary groups, including the pre-market review division and the safety office, come together to make decisions. If one office disagrees, it can appeal to higher-level officials. Currently, while this may often occur, it is more ad-hoc. Also, the pre-market drug-review divisions will each get their own new, dedicated officials whose responsibilities focus on safety.

“What you’re driving toward is the need to make these decisions in an objective, rational, systematic kind of way that’s open and transparent and that’s based on science and scientific analysis of the data,” said Dr. von Echenbach. “And to remove it from situations in which the decision may be affected … by somebody has a vested interest just emotionally, and intellectually.” He said the agency is creating a new appeals process in cases of scientific disagreement that can take a dispute up to the office of the commissioner.

The drug safety office will get primary authority over decisions to approve drug brand names and packaging, though this change will not occur immediately. Eventually, the safety office is supposed to formally get another power as well: the ability to commission certain kinds of research, the epidemiological studies often drawn from patient databases. This could involve requiring drug makers to do such studies — a power the FDA gained under a new law passed last year — or contracting with outside sources.

Ultimately, the FDA is supposed to implement a second phase to the plan, called Safe Use, that will focus on ensuring that drugs are used safely in the real world. But the agency official said there were few details available yet about the plan.