Healthy Skepticism Library item: 12943

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Publication type: news

Perrone M.
FDA to monitor use of prescription drugs by doctors, patients in shift from pre-approval focus
MSNBC 2008 Feb 26
http://www.msnbc.msn.com/id/23359633/

Full text:

At the urging of lawmakers concerned by recent drug recalls, regulators will start monitoring the use of medicines once they’re approved and in the hands of doctors and consumers.

As part of a larger safety initiative announced to staffers Tuesday, the Food and Drug Administration will urge doctors and patients to more closely follow safety guidelines when prescribing and taking drugs.

Influencing real-world use of drugs marks a shift from FDA’s traditional role as gate keeper for new medical products. The agency develops labels that detail how drugs are supposed to be used, but leaves the final prescribing decisions to doctors _ who are not required to follow federal guidelines.

The post-approval initiative was triggered by congressional action last year that broadened the agency’s drug oversight.

The agency can now order companies to change their drug’s labeling and conduct more safety studies. Previously, it had to negotiate with the companies. Congress gave the FDA that authority after several medicines, including Merck & Co.‘s blockbuster Vioxx, were pulled from the market because of their safety risks.

FDA’s pledge to more-closely monitor drug use comes less than two weeks after it proposed guidelines for how medical journal articles can be used to market drugs for unapproved uses.

Companies are not allowed to promote drugs for “off-label” uses, or those that have not been cleared by the FDA, but the agency makes an exception for medical-journal reprints, which pharmaceutical salespeople often give to doctors.

Lawmakers have criticized that proposal as too lenient, arguing it will allow companies to widely promote drugs for potentially dangerous uses.

Congress will hear the agency’s post-approval initiative Wednesday, when FDA Deputy Commissioner Janet Woodcock is expected to detail the “Safe Use” program at a House hearing.

The goal of shaping how doctors and patients use drugs “is a daunting but ultimately, I believe, highly rewarding objective,” Woodcock said in an e-mail sent to FDA’s drug reviewers Tuesday.

The e-mail was short on details, but Woodcock wrote that the agency would collaborate with health care providers to “minimize medical errors and manage risks aggressively.”

To more quickly spot drug safety problems on a national level, the agency is considering several options. One proposal involves gathering electronic information on drug reactions from insurers and hospitals and using it to advise physicians on prescribing decisions.