Drug Firm Agrees to Correct Naprosyn False Advertising
Williams, Rebecca D., FDA Consumer
All good advertisements pitch their products in the best possible light. But when it comes to advertising drugs, FDA won't allow those ads to be colored with deception.
FDA made that point clear recently in an investigation of Syntex Laboratories of Palo Alto, Calif., which had been advertising unapproved uses for an arthritis drug. Last October, FDA and Syntex signed a consent decree requiring the firm to stop the misleading advertising and set up a $2 million account to pay for a campaign to correct the misinformation.
The action came as part of a larger FDA initiative pushing for accurate labeling in thousands of foods, drugs, and medical devices and was hailed by FDA Commissioner David Kessler, M.D., as a landmark case and "an important and innovative approach to remedying promotional abuses by drug companies."
Syntex Laboratories had advertised that its top-selling product, a prescription arthritis drug called Naprosyn, was "arthroprotective"--that is, it could prevent joint deterioration from arthritis. In fact, no clinical studies have proven that claim. Naprosyn has been approved by FDA only for treating pain, inflammation and fever in people with arthritis and other inflammatory conditions.
Syntex promoted Naprosyn's alleged arthroprotective qualities in brochures, print advertisements, video programs and advertisements, and a seminar set up to look like an impartial medical forum.
FDA first learned of these violations in 1988 through routine checks of the company's advertisements. Whenever drug companies run new ads for print, video or radio, they must also submit copies to FDA before the ads run.
FDA warned Syntex that its advertisements were in violation of the Food, Drug, and Cosmetic Act. Syntex said it would stop using the term "arthroprotective"--yet it continued to suggest in promotional activities and materials that the drug could prevent joint deterioration.
In May 1991, Syntex advertised those claims again in a promotional booklet used by its sales representatives. David Banks, a consumer safety officer with FDA's division of drug advertising and labeling in Rockville, Md., quickly saw that the booklet violated FDA rules.
"They had been told specifically and repeatedly not to make claims of this type." says Banks, "and they went ahead and did it."
Since Syntex had repeatedly ignored FDA's warnings, Banks requested an onsite inspection of the company in Palo Alto, Calif. FDA investigators also took inventory of Naprosyn stock in two Syntex warehouse to prepare for a seizure if necessary.
FDA investigators Paul Peterson and Brian Hasselbalch from the San Francisco district office began their investigation in May 1991. …