One click is too far to go for risk information, according to a series of warning letters the FDA sent to drug manufacturers last Friday. The fourteen letters pointed out violations in online search engine ads for over 45 drugs made by some of the nation’s biggest drug manufacturers, including Glaxo-Smith-Kline, Merck, Eli Lilly, and Pfizer.
The FDA warning letters are consistent with the Pew Prescription Project’s request for the agency to articulate the rules regulating online advertising, which was made in a series of citizen petitions filed with the FDA last December. While three petitions dealt with online ads promoting three medical devices, a fourth petition urged FDA to take a strong public position advising all drug and device manufacturers on how close risk information and side effects, called “disclosures,” must appear to an internet ad.
Marking a significant shift in current industry standards, the FDA rejected the ‘one-click’ rule of thumb currently used by manufacturers, which often puts access to the product websites and full risk information one click away from these sponsored links. Though the FDA requires all prescription drug ads to include “disclosures,” a list of side effects, risk information, and indications for a drug, the ‘one-click’ standard has allowed drug companies to post YouTube videos and short ads such as ones that appear during a Google search without these disclosures, but with a link to the company website where the disclosures are posted. In its petitions, the Prescription Project argued that internet ads that failed to provide these disclosure direcly should be considered illegal by FDA.
FDA repeated consistently to all these manufacturers that merely providing a link to the drug’s website “is insufficient to mitigate the misleading omission of risk information from these promotional materials.” The letters ask that the companies remove the ads in violation and respond to the agency by April 9.
And in another good move for consumers swamped by DTC ads in every media, the FDA also advised these fourteen drugmakers to broadly review all their internet promotions for other drugs to ensure compliance with the advertising regulations, a move urged by the Project’s petition, as well.