Watchdog group to monitor DDMAC
Claiming the FDA's Division of Drug Marketing, Advertising and Communications (DDMAC), has been acting "outside its legal authority" for years by issuing warning letters to pharma marketers, the program, known as DDMAC Watch, will respond to federal regulators pointing out specific ways in which the group finds the agency's theories "legally deficient" or "ill-advised."
DDMAC Watch issued its first letter challenge on June 21, calling into question the FDA's most recent warning letter on Eli Lilly's attention deficit disorder therapy Strattera. In the letter, DDMAC Watch wrote: "DDMAC cites no evidence demonstrating that consumers cannot process the information presented in the advertisement. In fact, the TV advertisement conveys its message regarding attention deficit disorder so many times that it is incomprehensible that consumers would miss it."
WLF pointed to the lack of any statutory basis for sending warning letters. "Warning and untitled letters were invented by the FDA in the 1970s as a way of acting against a company without having to go to court," WLF said in a statement. "With no judicial safeguards to prevent abuses, FDA often uses warning and untitled letters to allege legal theories that are unsupported by the law and demand remedial actions that it lacks legal authority to require."