Emerging Side-effect Risk Alerts to be Posted by FDA Online
In May 2005 the FDA announced the establishment of a new web site, called Drug Watch, which will serve as the FDA's new online early-warning system for serious side effects arguably linked to FDA-approved prescription drugs.
The Drug Watch web site is a key part of the FDA's effort to increase public awareness of health risks from prescription drugs, in response to the groundswell of criticism -- which began in the fall of 2004, following the Vioxx recall -- over the agency's apparent poor performance in fulfilling its drug safety monitoring role.
A main function of the Drug Watch site will be the listing of prescription drugs which FDA reviewers think show emerging serious side effect risks that should be emphasized for the purpose of alerting doctors and patients, alike.
According to John K. Jenkins, director of the FDA's Office of New Drugs, the drug companies probably will not be allowed to edit or challenge the Drug Watch safety information in advance of news about serious side effect associated with their respective prescription drugs being posted on this new early-warning system web site sponsored by the FDA. "We don't expect they will have an opportunity to review the documents or provide comments before they're posted," Jenkins said. He clouded this issue a bit, however, when he went on to state that the drug companies will be notified in advance about a posting to be put on Drug Watch about one of their drugs, and the companies will be allowed to point out any factual errors in the FDA Drug Watch postings.
The all-important decision about which drug safety alerts to post on the Drug Watch web site will be made by members of the new FDA Drug Safety Oversight Board (DSOB). Susan K. Cummins, the Oversight Board's executive director, said that the DSOB will help "set standards" on when to put new safety warnings about certain prescription drugs on the Drug Watch site.
Essentially, the Drug Watch site is intended to allow the posting of serious side effect warnings that the FDA deems reliable but which, in fact, may go beyond the current version of a prescription drug's FDA-approved package insert label, or warning label.
Although it had been reported that, on a temporary basis, the Drug Watch alert system could be accessed by means of the FDA's web site -- www.fda.gov -- there is no apparent hyperlink for, nor any user information about, the Drug Watch site showing at present on the FDA homepage.
(Posted by: Tom Lamb)