Can consumers and health-care professionals spot deceptive prescription drug promotions? The FDA intends to find out.
The FDA is proposing a study to examine consumers’ and health-care professionals’ ability to detect and report deceptive representations in prescription drug promotions on websites. Plans for the study were submitted to the White House Office of Management and Budget for review and clearance, according to a Dec. 12 Federal Register notice (82 Fed. Reg. 58,411).
But a consumer group faulted the study, saying it focuses too much on consumers and physicians to catch deceptive advertising.
Not many people will know when an ad is deceptive because they either don’t know what’s in a drug’s label or they don’t know what a company is required to disclose in a website advertisement, Sammy Almashat, a researcher with Public Citizen’s Health Research Group, told me recently.
“We would like to point out that the FDA has primary responsibility to enforce its own laws and unfortunately, this has been happening less and less over the previous decade or so,” Almashat said.
Almashat also pointed out a decline in the number of FDA warning letters and untitled letters notifying companies that they violated advertising regulations. While the number of enforcement letters has declined, the number of drug ads hasn’t decreased at all, he said.
So far in 2017, the FDA’s Office of Prescription Drug Promotion (OPDP) issued only three warning and untitled letters for advertising violations. In 2016, the OPDP issued 11 letters.
Almashat also told me that the FDA hasn’t issued a fine to any company for violating any prescription drug promotion regulation even though the FDA Amendments Act of 2007 gave the agency the authority to impose civil fines on companies when direct-to-consumer ads are false or misleading.
“Essentially there’s little to no enforcement going on of prescription drug promotion, especially direct-to-consumer advertising; because OPDP simply doesn’t have the resources to follow up on all these ads and when they do identify an ad, they have to go through this very lengthy review process before they can even send a letter,” Almashat said.
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