FDA Advisers: iPLEDGE Needs More Tweaking
FROM A JOINT MEETING OF THE FDA DRUG SAFETY AND RISK MANAGEMENT AND DERMATOLOGIC AND OPHTHALMIC DRUGS ADVISORY COMMITTEES
Finally, the committee was asked to assess the burden on prescribers. According to data from Mylan, there are 14,444 registered prescribers in the iPLEDGE program, primarily with a specialty in dermatology (10,435, or 72%). Family physicians comprised the next largest group (2,095 prescribers 14%). Internists, ob.gyns., and pediatricians also were prescribers.
Mr. Shamp said that the program had become easier to manage for prescribers—a fact reflected by the declining volume of calls to the iPLEDGE call centers. Currently, there are about 20,000 calls a month, with an average hold time of a minute and an average time per call of just under 5 minutes, he said.
