AADA making derm perspective heard within FDA

March 1, 2006

FDA announced that the two topical eczema drugs must carry boxed warning labels about a possible risk of cancer.

There is an effort under way in Washington to increase the influence of dermatologists within the Food and Drug Administration (FDA), where many critical decisions are made that directly affect how dermatologists operate their practices every day.

The American Academy of Dermatology Association (AADA), according to President Clay J. Cockerell, M.D., is determined to increase dialogue with FDA officials and policymakers with this objective in mind.

In a message to Academy members Jan. 23, Dr. Cockerell noted that the FDA, just three days earlier, had approved "black box" warnings and medication guides for Elidel cream (pimecrolimus, Novartis) and Protopic ointment (tacrolimus, Astellas), and that manufacturers are expected to switch to the new labeling as soon as possible.

FDA announced that the two topical eczema drugs must carry boxed warning labels about a possible risk of cancer. A medication guide will be distributed to help ensure that patients using the prescription medications are aware of the concern. FDA said the new labeling must clarify that the drugs are recommended for use as second-line treatments, after other prescription topical medications have been tried.

In a public health advisory, issued early last year, FDA warned healthcare providers and patients about a potential cancer risk from the use of the two products.

"This concern is based on information from animal studies, case reports in a small number of patients and how these drugs work," the FDA states. "It may take human studies of 10 years or longer to determine if use of Elidel or Protopic is linked to cancer. In the meantime, this risk is uncertain and FDA advises that Elidel and Protopic should be used only as labeled, for patients who have failed treatment with other therapies."

Academy disagrees

The Academy issued a statement on Jan. 19 disagreeing with FDA's action, stating that the two medications effectively reduce the inflammation and other symptoms associated with eczema and that "The data does not prove that the proper topical use of (the drugs) is dangerous."

"Because these medications are applied to the skin, virtually none of it gets inside the body," AAD says. "It's not the same as taking a pill. These are valuable medications, and if used properly, they allow millions of our patients with eczema to live normal lives."

In his message to members, Dr. Cockerell pointed out that a scientific consensus conference organized by the Academy last July confirmed "that a causal relationship has not been established in the rare cases of cancers that have been reported in patients treated with TCIs - a finding that even the FDA acknowledged in the new black box warning itself."

Dr. Cockerell says the Academy is concerned that the new labeling restrictions could limit access to the medications if qualified patients choose not to use them because of a fear of cancer. AAD has made an information sheet available on its Web site to help dermatologists assist patients in making informed decisions about eczema medication.

He pointed out that the development with TCI labeling "is just one example of the many ways in which the FDA affects the daily practice of dermatology." He said enhancing the Academy's influence on FDA actions is a priority, and the Academy's Ad Hoc Task Force on FDA Relations is facilitating high-level meetings between AAD officers and FDA officials "to ensure that the dermatology perspective figures prominently in the development of FDA policies."

Reinforcements

As part of this effort, he says, task force chairman Robert A. Silverman, M.D.; James Q. Del Rosso, M.D., chairman of the Academy's Environment and Drugs Committee; and Dr. Cockerell met with Gerald Dal Pan, M.D., the new head of the FDA Office of Drug Safety, on Jan. 9 - less than two weeks before the FDA's "black box" announcement.

Related Content:

Pediatric Dermatology