"We felt [the ad] was especially egregious and posed a public health concern," said Nancy Ostrove, chief of the FDA's research and review branch of its Division of Drug Marketing, Advertising & Communications.
The warning letter is an unusually strong step for the FDA. Normally, the agency sends out what it refers to as an "untitled letter," which simply asks the marketer to yank the problematic ad out of circulation and alter it, but does not force it to pay for so-called set-the-record-straight ads. Kos had until July 27 to inform the FDA of its plans to run corrective ads. As of July 26, Ms. Ostrove said she had not received a response.
A Kos spokeswoman said July 27 the company would provide the information, but declined any further comment, except to say the ad was only expected to run once. She also declined to release the name of the ad agency that developed the ad. An FDA spokeswoman said people authorized to comment were unavailable at press time.
The FDA warning comes as Kos received some good news from another arm of the federal agency last week. The FDA said Kos' potential blockbuster entrant in the cholesterol-reduction category, Advicor, should be approved for marketing later this year. Advicor is a combination of Niaspan, an extended-release form of B vitamin niacin and a generic version of Mevacor made by Merck & Co, which is scheduled to go off patent in December. Advicor will be co-marketed by Dupont Pharmaceutical Co. and is expected to be introduced in the first quarter of 2002.
Niaspan carries a warning in bold on its packaging-one step below a "black box" warning-concerning its potential for liver damage when extended-release Niaspan is substituted by a consumer for an equal dose of an over-the-counter version of niacin B vitamin. The ad does state "people with liver problems ... should not take Niaspan" in small print, but the FDA felt that was inadequate.
Another warning in bold type states Niaspan must be used cautiously if a person drinks abundantly or has a history of liver disease. The FDA maintains neither risk is sufficiently communicated to consumers in the print ads. Further, the FDA maintains the ad "promotes" using Niaspan with a simvastatin such as the fast-selling Zocor from Merck, but it does not mention potential negative effects on muscle tissue from the combined usage.
Ms. Ostrove declined to comment on whether the remedial ad would have to run in Time or if another distribution avenue would be appropriate. Time had a circulation of 4.1 million for the second half of last year, according to the Audit Bureau of Circulation, so in theory an outlet would have to reach at least that many people. Kos, a neophyte in the direct-to-consumer arena, doesn't register on Taylor Nelson Sofres' CMR and it was unclear how much the one-time Niaspan ad cost. A color page in Time is listed at $192,000.
Kos may have escaped the warning letter had Ms. Ostrove been a Newsweek subscriber. But she subscribes to Time and came across the Niaspan ad herself in the back of the June 11 issue.