Dr. Margaret Hamburg, the newly appointed chief of the Food and Drug Administration (FDA), is flexing her muscles with drug makers over questionable product promotion, in an effort to live up to her promise to step up enforcement of oversight of drug makers, device manufacturers and other companies the agency oversees. Last year, the FDA issued 41 enforcement letters, twice as many as it issued in 2008.
“We’re trying to get the point across to industry that we want them to comply with the law because it affects public health,” Thomas Abrams, head of the FDA’s Drug Marketing, Advertising and Communications Division, (DDMAC), told Reuters. “If you don’t comply with the law, we are going to take action. We are not going to tolerate having consumers or health care professionals misled.”
DDMAC is charged with reviewing all drug promotions to consumers and health professionals, including television advertisements, Web sites and conference print materials, which companies are required to submit to the FDA for approval when they are made public. If DDMAC considers an advertisement to be overstating a drug’s benefits, the division issues a letter of enforcement. If at all possible, Abrams said, the agency tries to work with companies before they begin promotions to avoid sending out a misleading message.
Hamburg’s initiative on the matter, and a more streamlined process within DDMAC for reviewing product promotions has made the system run much more smoothly, Abrams said. The FDA announced it has already issued nine letters for the month of January.