On March 10, 2005 the FDA announced their intention to include a black box warning and to develop a patient medication guide for the topical calcineurin inhibitors, Elidel and Protopic, to treat eczema. Both measures are typically considered extreme and are usually reserved for urgent situations requiring an immediate public health warning. In this case, though, the dermatology and allergy communities do not agree with FDA’s intended actions.
On April 5, AAFA sent a letter to the FDA echoing the concerns of the allergy and dermatology communities that a black box warning and medication guide do not seem to be the best mechanisms for communicating risk in this situation. AAFA argues in the letter that the millions of prescriptions for these drugs over the past few years reflects the unmet need for alternative treatments and, potentially, the growing number of Americans who suffer from allergic disease.
The letter asks the agency to reconsider and to renew efforts with its advisors and with the drug sponsors to find alternative outreach mechanisms to properly educate health care professionals and patients on these important therapies. If you have any questions or need further information, please contact Mo Mayrides, AAFA Director of Public Policy, at (202) 466-7643 x273 or by email at firstname.lastname@example.org.
Download a copy of the letter to the FDA.