New research recently reported in MedPage Today suggests that only a limited number of advertisements for prescription drugs are actually in compliance with FDA regulations on marketing to doctors. The research, which was conducted by Dr. Deborah Korenstein of Mount Sinai School of Medicine in New York, revealed that during a one month period, almost half of the drug advertisements missed the mark on at least one main rule of thumb and at least one third of the ads were possibly noncompliant due to incomplete information. Also, more than half of the ads failed to fully quantify serious risks associated with use of the featured product.
Simply stated, The FDA does not have the resources or the money to review every ad that runs. With a marketing budget of approximately $58 billion, the pharmaceutical industry can easily overwhelm the regulatory agency’s drug marketing and advertising division. In fact, the division operates with a $9 million budget, which pales in comparison to that of big pharmaceutical companies. With so little allotted to help the FDA enforce its regulations, the agency has to get a bit creative in its approach to cracking down on noncompliant advertisements.
WIth that said, the FDA has recently stepped up its game and implemented the “Bad Ad” program. This program asks that physicians report non-adherent or misleading ads. While a good idea in theory, the Bad Ad program is still highly subjective and difficult to enforce. Moving forward, Korenstein and fellow researchers have suggested that the FDA update and streamline the guidelines for the Bad Ad program.
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