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In an unusual move, the FDA has approved the diabetes drug Symlin on condition of a series of heavy advertising restrictions.
The agreement between the agency and manufacturer Amylin calls for a ban on DTC advertising, restriction of journal advertising for one year after the drug's launch and limited promotion to physicians specializing in diabetes management.
Symlin was approved by the FDA on March 16 for use at mealtime in patients with type 2 or type 1 diabetes who have failed to achieve blood sugar levels despite their having taken insulin, but can cause insulin-induced hypoglycemia if taken incorrectly.
Amylin said it agreed with the FDA restrictions.
"We feel the guidelines are consistent with the best introduction of the drug to diabetes patients because it can cause insulin-induced hypoglycemia," Alice Bahner, Amylin executive director of investor relations said. "We were very happy to comply with the FDA's request."
FDA spokeswoman Crystal Rice said, "Once experience is gained and we see how other risk management measures are working, we can work with the company on expanding marketing. These restrictions were voluntarily put in place by the company as measures to address FDA concerns on how a novel product like this would be best marketed, given what was seen in clinical trials."
In an undated letter to Amylin from Robert Meyer, director of the FDA's Office of Drug Evaluation II, Center for Drug Evaluation and Research, the agency cited the following agreements related to risk management concerns:
• No direct-to-consumer advertisement.
• No journal advertisement for one year after Symlin is launched.
• Promotion limited primarily to physicians who specialize in diabetes management and are supported by certified diabetes educators.
• Gradual introduction of Symlin into the marketplace, with concomitant evaluation of patterns of Symlin use by "targeted" and "non-targeted" health care providers.
• Conduct of a postmarketing observational study to assess the potential hypoglycemic risk for Symlin in the actual use setting.
• Surveillance plan: reporting of severe hypoglycemic events in an expedited manner for two years or as long as the postmarketing observational study remains ongoing, whichever is longer.
• A 24/7 nationwide call center to assist patients and physicians with the use of Symlin.
The letter is posted on the FDA's Web site.