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FDA COMMISSIONER KESSLER IS SCHEDULED TO TESTIFY ON RETIN-A

Executive Summary

FDA COMMISSIONER KESSLER IS SCHEDULED TO TESTIFY ON RETIN-A promotions for unapproved anti-aging indications at a June 11 hearing before Rep. Weiss' (D-N.Y.) House Intergovernmental Relations Subcommittee. Agency commissioners have not made a habit of testifying at Weiss hearings; however, Kessler has agreed to make an exception for Retin-A, presumably due to his expressed personal interest in the need for FDA to crack down on allegedly false and misleading promotions. A subcommittee announcement states the hearing will examine "illegal promotion of prescription drugs and medical devices for cosmetic treatments that have not been approved by FDA" ("The Pink Sheet" June 3, p. 3). "The hearing will focus on the adequacy of FDA efforts to protect the public from the potential dangers associated with the unapproved use of drugs and devices, including Retin-A," the subcommittee said. "Retin-A is approved for acne, but its improper promotion has led to wide use for wrinkles and precancerous skin conditions; it has not been proven safe or effective for either." Others invited to testify include "patients who have used" Retin- A, "scientists and public health officials" and representatives of Retin-A marketer Ortho Pharmceuticals, the subcommittee noted.
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