This week it was announced that a senior fellow from the office of Senator Edward Kennedy would be heading back to FDA as a senior counselor to Dr. Joshua Sharfstein where it is reported that the FDA Office of Legislative Affairs will report to him. Formerly, before going to Kennedy's office, Dorsey was in the FDA's Office of the Chief Counsel respecting the regulation of medical devices.
In Kennedy's office, part of his concentration was on FDA where he reportedly worked on several proposals that became legislation, including the Best Pharmaceuticals for Children Act, the re authorization of PDUFA; the Pediatric Research Equity Act, generic drug provisions of the Medicare Modernization Act and the FDAAA of 2007.
Based on past reported comments, his appointment may mean even further curtailment of Direct-to-Consumer advertising. The comments were reported in a Medical Marketing and Media article from 2004 which stated that he favored giving the "FDA greater enforcement authority over such ads, prohibit referrals to online or other sources in lieu of the required risk information and require that all DTC ads include MedGuide-like risk information."
Granted, since 2004, there has been a lot of intervening legislation that does give FDA greater authority. But it is worth noting that he also was reported to have called DTC ads "problematic" which certainly signals the potential for a greater curbing of future DTC and might imply that any proposal that would call for DTC moratoria of any length would not be resisted by the FDA.
Bottom line – Mr. Dorsey's position, combined with the FDA's recent confusion about DTC rules (on-line reminder ads with a link to a landing page containing risk information is not allowed, print journal ads where you have to turn the page to get risk information is apparently allowed….) it would seem almost certain that DTC is in for some rocky shoals in the coming months.
