Syntex Labs to Correct ‘Misleading’ Promotion : * Regulation: In order to settle an FDA complaint, the firm will launch a $2-million advertising campaign to tone down claims for an arthritis drug.

Syntex Laboratories will spend $2 million to begin an extensive multimedia advertising campaign to correct its past “misleading” promotion of a widely used arthritis prescription drug, the Food and Drug Administration announced Thursday.

FDA Commissioner David A. Kessler called the agreement--a consent decree between the Palo Alto, Calif., company and the FDA filed Thursday in federal court--a “landmark case” that “delivers a strong message to other firms.”

The agreement is “an important and innovative approach to remedying promotional abuses by drug companies,” Kessler said. “I see the decree as a precedent for dealing with those who would mislead physicians or patients on matters affecting the public health.”

The action came as part of the FDA’s new and vigorous get-tough policy with companies over the labeling and promotional practices for thousands of foods, drugs and medical devices over which the agency has jurisdiction.

The company had pitched the drug, Naprosyn, to physicians as one that could prevent and reverse the joint degeneration associated with arthritis, the FDA said. In fact, the medication only relieves symptoms of the disease, which include pain, inflammation and fever, the FDA said.

“This is a valuable drug--but the company was saying that it turns the disease around,” Kessler said in an interview. “That is simply not true. You can’t say it reverses arthritis when it doesn’t.”

The agency and the company had been wrangling since 1988 over the way the drug was being promoted to physicians by sales representatives, through advertisements in medical journals, cable-television programs and advertisements, and during physicians’ educational seminars.

Company Chairman Paul Freiman, in a statement issued earlier this week, said the company does not admit any wrongdoing but signed the agreement “because we felt it was in the best interests of our customers, physicians, patients, employees and shareholders to put this incident behind us and to move forward on a positive note.” Company officials refused further comment Thursday.

As part of the deal, the company also will send certified letters to 250,000 physicians admitting that the drug is not effective in reversing arthritis and informing physicians of the FDA’s findings regarding “the false and misleading nature” of its prior Naprosyn promotions, the FDA said.

Syntex also agreed to reimburse the FDA $131,000 for the costs associated with the investigation, the agency said.

The company also will be required to run corrective messages about the drug in each of the 18 medical journals in which Naprosyn was “improperly promoted,” and place similar ads on Lifetime Medical Television, where the company “had run programming and advertisements for Naprosyn that were misleading,” the agency said.

The company will also be required to continue the remedial education and advertising campaign for one year, unless it can demonstrate “certain prescribed levels of physician awareness” of the new corrective information before that time, the FDA said.

Kessler stressed that Naprosyn is still considered “safe and effective” for the relief of arthritis symptoms and said that the drug would continue to be marketed, subject to the terms of the decree.