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FDA Introduces Rules Aimed At Limiting Drug-Makers' Influence

May 20, 2005 | Knight Ridder Newspapers

Senior officials of the Food and Drug Administration unveiled new drug-safety rules Friday aimed partly at reducing the influence of drug-makers on certain FDA actions.

Steven K. Galson, acting director of the FDA's Center for Drug Evaluation and Research, said during a panel discussion in Washington that members of the agency's new Drug Safety Oversight Board will face stricter conflict-of-interest requirements.

He contrasted the new rule to current practice in which FDA advisory committee members - often outside experts - are sometimes allowed to vote on a product even if they had worked on it or took money from a manufacturer at some point.

"It's been very controversial that we often waive these conflict of interest (rules) for advisory committees. We will not be doing that for this board," Galson said during a review of the FDA's new drug-safety initiatives, mainly for drug companies.

Also, drug companies will not be allowed in advance to edit or challenge safety information being posted on the FDA's new early-warning system, called Drug Watch, said John K. Jenkins, director of the FDA's Office of New Drugs.

Currently, most risk-benefit information disseminated by the FDA is based on warning labels that were negotiated by regulators and drug-makers. Drug Watch will include serious warnings the FDA deems reliable, even if they go beyond the warning labels.

"We don't expect they will have an opportunity to review the documents or provide comments before they're posted," Jenkins said. Companies will be notified in advance about a posting and will be allowed to point out factual errors in the texts.

But "most of the complaints, so far, have been differences of opinion. They interpret things one way, we interpret things another," in which case the FDA will not accept changes, Jenkins said.

Drug Watch is the agency's latest effort to increase public awareness of health risks from prescription drugs, in response to a public backlash over drug safety in the last year.

Launched recently, the Drug Watch system currently is posted on the front page of the FDA's Web site, As of Friday it listed more than 200 prescription drugs that carry particular risks that FDA reviewers consider worthy of emphasis.

Giving an example of its value, Jenkins said the system could have been used last year to highlight reports of suicide risk from anti-depressants and cardiovascular risk from Cox-2 inhibitor pain relievers.

The latter included the pain-reliever Vioxx, made by Merck & Co. Inc. Studies had raised questions about Vioxx since 2000. Merck voluntarily recalled Vioxx in September after its own study confirmed the risks.

"I think it's likely that (Vioxx) would have been on there, although I don't know how the oversight board might have altered events as they played out," Jenkins said.

Decisions about which alerts to post on the Web site will fall to the new 12-member safety oversight board. The FDA announced the members' names on Wednesday; all but a few are top officials at the agency.

"It's about more information, better information, faster information. It's not about getting people to take fewer drugs," Galson said of Drug Watch.

Susan K. Cummins, the board's executive director, said it will help "set standards" on when to put safety warnings on drugs, when to alert the public about a problem, and how to address concerns of FDA reviewers about drugs who otherwise might not be heard.

On Nov. 18 last year, David Graham, the FDA's associate director for science and medicine, testified in Congress that the agency was failing to protect the public and had allowed five dangerous drugs in addition to Vioxx to remain on the market. The FDA has rejected his criticism and has not banned any of the drugs.

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