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FDA Plan to Ease Off-Label Marketing Rules Draws Criticism

Apr 7, 2008 | Parker Waichman LLP Medical researchers are concerned over some proposed guidelines issued from the US Food and Drug Administration (FDA) that would allow companies to market more drugs for unapproved uses—a move seen as a reversal, by some—according to a researcher from the Stanford University School of Medicine.  Randall Stafford, MD, PhD, associate professor of medicine at the Stanford Prevention Research Center, criticized the draft guidelines.  Guidelines are open to public comment through April 21 and lessen the FDA's already limited authority over the marketing of drugs for off-label uses, according to Stafford, whose editorial is to be published in the April 3 issue of The New England Journal of Medicine.

It is generally assumed that medications prescribed by US doctors always receive FDA approval; however, the FDA approves drugs for specific purposes and physicians can prescribe use drugs "off-label" for medical conditions for which the drugs were not approved by the FDA.  Off-label prescribing for medical conditions not scrutinized during the FDA approval process occurs routinely and off-label prescribing is legal and—often—is good medicine, according to Stafford, who directs Stanford's Program on Prevention Outcomes and Practices.  Once the FDA approves a drug for one condition, physicians are free to prescribe that drug for any reason.

The problem occurs because what is known about a drug in one situation may not apply to other clinical scenarios.  For instance, Stafford explained, the use antidepressants in children and the use of antipsychotic medications for dementia.  "The FDA should not suddenly start telling physicians how to practice.  Physician judgment is critical, especially when approved therapies have not succeeded.  Off-label prescribing can be an important tool in such cases," he said. "But in other cases, off-label prescribing has become first-line therapy even in the absence of strong evidence of benefits and safety.  This is problematic."  Stafford feels these situations suggest improved off-label drug evaluation and regulation is needed and that—in the best case—a drug maker would return to the FDA with additional clinical studies and to obtain supplemental approval for a new clinical use.

Off-label drug use is common; however, FDA applications seeking approval of new uses are rare, said Stafford.  And, although FDA regulations restrict drug manufacturers from overtly promoting drugs for unapproved conditions, manufacturers are legally able to share educational materials with physicians, generally in the form of published journal articles.  According to current FDA guidelines, this is acceptable if the manufacturer submits the articles to the FDA for review and pursues formal FDA approval for the new use. FDA enforcement is limited, said Stafford and the new draft guidelines further restrict FDA involvement by eliminating both these requirements and reduce remaining policies to non-binding recommendations.

One of the proposed guidelines' major problems according to Stafford, would be allowing drug manufacturers to skip obtaining approval for potentially lucrative drug uses.  Companies might seek approval only for a narrower, more easily and less expensively tested, use, sponsoring research on more commercially promising uses never evaluated by the FDA. Stafford warned that this might encourage widespread treatment of conditions with drugs never approved by the FDA for those purposes.

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