Dec. 22, 2017 — The FDA recently announced that it was planning to study whether consumers and healthcare professionals have the ability to “spot and report” deceptive prescription drug promotion practices (https://www.gpo.gov/fdsys/pkg/FR-2017-12-12/pdf/2017-26704.pdf).
The FDA’s Office of Prescription Drug Promotion (OPDP), which issued the lowest number of enforcement letters ever in 2017, appears to be looking to the public to help it monitor potentially deceptive drug promotion. The FDA is proposing a study that would assess whether consumers and healthcare professionals “can identify claims as false or misleading, and whether they would be willing to report deceptive drug promotion to the FDA.”
“Promotional material that drug makers share with patients and providers can be a helpful tool for encouraging patients to seek medical care and raising awareness about new and different treatment options,” said FDA Commissioner Scott Gottlieb, M.D., in an “FDA In Brief” release issued Dec. 11. “The FDA plays an important role in helping to make sure these presentations are truthful, balanced, and nonmisleading, and we need to study promotional material to constantly improve our oversight over these activities. A key to our oversight is recognizing claims in prescription drug promotion that have the potential to deceive or mislead consumers and health care professionals.”
In the Federal Register announcement of the study, the FDA states that the ability of consumers and HCPs to identify deceptive prescription drug promotion “has important public health implications.” The agency comments that in consumers are unable to spot deceptive promotion, they “may ask their HCPs to prescribe specific drugs that they would not otherwise request.” Further, if HCPs cannot identify deceptive promotion, they “may prescribe specific drugs that they would not otherwise prescribe.”
However, “on the other hand, if consumers and HCPs are able to identify deceptive promotion, they may appropriately discount or disregard such information in their medication decisions, and perhaps even report deceptive promotion to appropriate government regulators who can take corrective action,” according to the notice.
The FDA’s most recent attempt to engage healthcare professionals in promotional monitoring – the Bad Ad program launched in 2010 – did not yield any significant enforcement activity.