The FDA has asked Gilead Sciences to remove a sponsored link on Google that misrepresents the drugmaker’s hepatitis B drug, Viread, and omits risk information, the first such enforcement action since the agency issued guidance on character-limited advertisements last month.
The tiny link was the subject of an untitled letter released by the agency’s Office of Prescription Drug Promotion.
The FDA said the ad improperly touts Viread (tenofovir disoproxil fumarate) by using the word ‘prevention’ when the drug is approved only for treatment of chronic hepatitis B. The link also doesn’t include any risk information on Viread, instead pointing readers to the main website for the product, the agency said.
In its June draft guidance, the agency made clear that advertisements, no matter how brief, must contain balanced risk/benefit information.
Viread has a black box warning due to fatal cases of lactic acidosis and severe hepatomegaly with steatosis and post-treatment exacerbation of hepatitis. OPDP also rapped Gilead for not submitting a Form FDA-2253, which is required for all advertisements of a drug product, according to the June 27 letter.
While sponsored links aren’t a common cause of untitled letters, drugmakers have been cited before. In 2009, the FDA warned 14 drugmakers about sponsored links promoting nearly 50 drugs. Products cited included Sanofi’s Plavis (clopidogrel bisulfate), Genentech’s Avastin (bevacizumab) and Lucentis (ranibizumab), Pfizer’s Celebrex (celecoxib) and Novartis’ Femara (letrozole).
Gilead has reviewed the letter and is working to address the agency’s concerns, spokeswoman Michele Rest said.
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