PhRMA revived its push to add an FDA bug linking to risk info in search engine sponsored links and called on FDA to clear the way for “microblogging of newsworthy regulatory events” on drugs and biologics.
In response to an FDA call for comment on the use of online media by drug companies, the trade group proposed a paid search format somewhat similar to that proposed by Google. PhRMA’s format would feature the drug’s branded and generic name, followed by an “abbreviated indication or therapeutic category,” and then, in the left hand corner, an FDA logo reading “FDA regulated” that links to risk information, along with a line warning of risks and linking to the patient medication guide.
For drugs with boxed warnings, PhRMA suggested, the line might read “You should be aware of serious risks associated with this product.” For those without a boxed warning, the line would read “All drugs have risks. Click here for important safety information.”
PhRMA officials first proposed the use of the agency’s logo to denote regulated communications in November. At the time, agency officials expressed skepticism because of concerns about misappropriation of the logo and how information would be regulated.
A year ago, the agency’s Division of Drug Marketing, Advertising and Communications issued 14 enforcement letters on violative sponsored links, torpedoing industry assumptions that as long as a link were provided to full-risk information, advertisers were safe to use space-constrained media such as paid search and banner ads for product communications.
PhRMA’s Jeffrey Francer called the application of regulations developed for printed materials aimed at healthcare professionals to Internet communications “akin to using standards created for the horse and buggy to regulate automobiles.”
“Right now there are no internet-specific standards on how manufacturers can use these media,” said Francer on a conference call. “The lack of such standards is chilling the use of such technology.”
For space-constrained media such as Twitter posts, or tweets, PhRMA said the agency should allow manufacturers to offer brief “introductions” to health information, including brief indication descriptions, much as FDA itself does.
“Of course, such an introduction should also contain an affirmative statement about the risks of a medicine, even if initially abbreviated and continued in a pop-up or link,” said PhRMA in its submission. “A condition of providing initial benefit and risk information in an abbreviated format could be that such entries contain prominent and clearly marked links indicating that users should view more comprehensive information such as full indication, full risk information and more complete fair balance.”
Former Pfizer top lawyer and FDA law expert Arnie Friede called PhRMA’s brief “persuasive” but said it left unaddressed the 800-pound elephant that is the agency’s profound distrust of pharmas to market their products responsibly.
“Absent some empirical justification for concluding that industry can be ‘trusted’ insofar as social media is concerned, and despite the admitted fact that consumers search for relevant health information on line, I have a hard time believing that FDA is going to provide meaningful long-term relief,” said Friede.
