Allergan challenges government's 'off-label' use

FoodConsumer.org reports that a suit recently filed by Allergan regarding Botox (not the cosmetic version) could be precedent-setting. A press release on Allergan’s Web site says, “Under current law, drugs are approved by the FDA for specific uses. Once a drug is approved, physicians may exercise their informed medical judgment to prescribe the drug for any use, including off-label uses. It is estimated that approximately 20 percent of all prescriptions in the United States are used by physicians for off-label indications.” The FDA offers information on “off-label” and investigational use of marketed drugs, biologics, and medical devices.

Allergan, Inc., an Irvine, CA-based health care company focused on discovering, developing, and commercializing pharmaceuticals, biologics, and medical devices, contends in the press release: “The lawsuit only seeks to permit Allergan to proactively provide the medical community with truthful, important information about common off-label uses of Botox. Moreover, far from seeking freedom from regulation, Allergan hopes this suit will lead to clear regulatory guidance on how it can lawfully provide accurate and relevant information on the full range of issues physicians should consider in determining the best therapies for their patients.”

FoodConsumer.org’s Rachel Howell Stockton concludes, “This is a precedent setting case, as Botox’s unique position has made it possible for some lessening of FDA regulations. However, critics say that the FDA would be rendered “useless” if drug companies are able to go full throttle with their advertising.”