FDA's Division of Drug Marketing, Advertising and Communications (DDMAC) took Novartis to school over educational websites the agency said went beyond disease awareness, and into brand promotion, according to a Warning Letter dated April 21.
Although Novartis' Gleevec was not mentioned by name on the two violative sites—www.gistalliance.com and www.cmlalliance.com—the websites “effectively promote this drug product for the treatment of GIST tumors and CML, respectively,” the letter stated.
Since the websites were considered to be brand promotions by DDMAC, other problems arose, including minimization and omission of risk, promotion of unapproved use of the drug, and unsubstantiated dosing claims, according to the letter. Novartis also failed to submit the website contents to FDA prior to dissemination, as required by law.
GSK received an untitled letter in April regarding a disease awareness ad that alluded to its cancer treatment Arzerra, but left out the drug's side effects. Disease awareness ads are not required to include medication risks and other information that is required by product advertising, since they don't ostensibly promote a specific product, according to FDA's 2004 draft guidance. Where exactly disease education ends and brand promotion begins is a matter for debate.
“The implications of that letter here are that [FDA is] going to construe the disease-awareness exception very narrowly,” said Arnold Friede, a former top Pfizer lawyer and expert on FDA law. “It also reflects their desire to stake out a broad scope for what their authority is.”