Both Afinitor and the newly-approved Afinitor Disperz were both approved through the FDA’s Accelerated Approval Program. Through the Program, drug sponsors are able to obtain expedited approval of drug products that are intended to treat serious diseases in situations where there is an unmet medical need. Though this process is accelerated, drug sponsors are still required to perform studies to confirm that the drug product provides the anticipated clinical benefit. In addition, drug sponsors may be required to perform ongoing studies in order to ensure the long-term safety of drugs approved through this process. In fact, both Afinitor and Afinitor Disperz are subject to these ongoing studies. More information about the FDA’s Accelerated Approval Program may be accessed here.

This week has marked a number of firsts with respect to drug approvals. As we recently reported, on August 27, 2012, the FDA approved a new four-in-one combination pill for the treatment of the HIV-1 infection in adults who have not previously received treatment for the infection. For more information about the FDA approval process or the laws and regulations enforced by the FDA generally, please contact us at contact@sglawfl.com.

Under the Federal Food, Drug and Cosmetic Act (“FFDCA”), the legislation enforced by the U.S. Food and Drug Administration (“FDA”), drugs are approved for specific uses, known as the “intended uses.” Under the FFDCA, pharmaceutical manufacturers and/or distributors may not market or otherwise represent their products for uses other than those approved by the FDA. While this practice, known as “off-label” marketing is forbidden, this is not to say that off-label use is also prohibited by the FFDCA. In fact, countless drugs are used for uses other than those approved in labeling. In the present case, because the FFDCA prohibits marketing of these uses, GlaxoSmithKline was targeted by the FDA for claiming that Paxil and Wellbutrin were beneficial in treating adolescents, a segment of the population for which the drugs were not approved.

In addition to off-label marketing prohibitions, manufacturers of pharmaceuticals are typically required to conduct post-marketing studies as a condition of approval. These studies are required in order to demonstrate the continued safety for consumers. With respect to GlaxoSmithKline , the Company allegedly failed to disclose data concerning the safety of its diabetes drug Avandia. Ultimately, this case illustrates that no matter how large and established, manufacturers must be diligent in their efforts to comply with federal laws and regulations or be prepared to face ample consequences.