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FDA Announces New Drug Safety Initiative

Feb 27, 2008 | Parker Waichman LLP The Food & Drug Administration (FDA) is going to be giving drugs more scrutiny once they are approved and on the market.  The new policy comes as lawmakers,  concerned by the rash of recent drug recalls, have been urging the FDA to step in and implement standards to help alleviate these issues.  Also, as part of a larger safety initiative announced to staffers Tuesday, the FDA will strongly recommend that doctors and patients more closely follow safety guidelines when prescribing and taking medications.  This post-approval initiative was triggered by congressional action last year that broadened the FDA’s drug oversight responsibilities

This influencing of actual drug usage is a change from the FDA's traditional role as that of monitor, or gatekeeper, for new drugs and medical products.  Up until now, the FDA developed the labels that detail how drugs are meant to be used, but it left the final prescribing decisions to doctors, who are not bound by federal guidelines and can prescribe medications for off-label—uses other than what is FDA approved—uses.  

But, now, the FDA can order drug companies to both change their drug's labeling and conduct more safety studies on those drugs.  In the past, the FDA only had the ability to negotiate with the drug makers and was not in a legal position to compel the drug makers to make changes or implement safety studies. Congress allowed for the change and the increased authority to the FDA when several medicines—including the highly publicized issues with Merck & Co.'s Vioxx—were pulled from the market because of their safety risks to consumers.  The FDA's commitment 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.  It is illegal for companies to promote drugs for "off-label" uses, or those uses not approved by the FDA; however, the FDA does make exceptions for medical journal reprints, which pharmaceutical salespeople often pass on to doctors.  Lawmakers have criticized that proposal as being too lenient and have argued that the proposal will allow drug companies to widely promote drugs for potentially dangerous uses.

Today, the FDA will be presenting to Congress on a post-approval initiative.  FDA Deputy Commissioner Janet Woodcock is expected to detail the "Safe Use" program at the scheduled 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 the FDA's drug reviewers Tuesday.  The e-mail did not provide a great deal of information; however, Woodcock wrote that the FDA would collaborate with health care providers to "minimize medical errors and manage risks aggressively.”  In an effort to more quickly spot drug safety problems on a national level, the FDA is considering a variety of options.  One such option is a proposal that involves gathering electronic information on drug reactions from insurers and hospitals and using that information to advise physicians on prescribing decisions.

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