As first reported by Regulatory Focus, the FDA sent a request to start the survey to the White House in January and received five comments on the project — including ones from Merck and Bausch + Lomb.
The FDA’s request, which was posted in the Federal Register, said the marketing practices likely affect the “daily interactions between patients and nurse practitioners and physician assistants.”
Regulating DTC marketing, as the FDA’s new study hopes to understand, is a difficult task, the NIH paper says.
“[The difficulty is] compounded by the disproportionate size of the DTC marketing budget for the pharmaceutical industry, which is nearly twice the budget for the entire FDA, let alone the office in charge of the regulation of DTC advertising,” Drs. Jeremy A. Greene and David Herzberg write. “Moreover, pharmaceuticals represent an extreme case of a common situation, where consumers' choices are constrained by ‘learned intermediaries’ in a market defined by vast and seemingly inescapable imbalances of knowledge and power.”
In its comments about the study, Merck said federal regulators should investigate how drug advertising affects prescribing decisions. Bausch + Lomb, however, said it thought that line of questioning went beyond the scope of the survey.