FDA shows no let up on ad/promotion warnings, despite WLF case loss.

Dear Reader,

Despite a setback to FDA policy when a federal court in July struck down agency oversight of off-label use dissemination, FDA has shown no let up in the number of warning and "untitled" letters it is slapping on makers of drugs, devices and biologics.

In fact, on Sept. 1 just a day before the Department of Justice appealed the decision in Washington Legal Foundation (WLF) v. Henney the Division of Drug Marketing, Advertising and Communications (DDMAC) in the Center for Drugs issued a warning letter to Dey Labs for allegedly providing "false and misleading" information to doctors about Atrovent.

In the WLF case, Judge Royce Lamberth said FDA could not require pre-clearance for manufacturers to disseminate journal reprints carrying information about unapproved uses due to First Amendment protections of "commercial speech," despite the fact that Congress granted the agency this authority in the FDA Modernization Act of 1997.

At the Food & Drug Law Institute's annual advertising and promotion conference in Bethesda, MD, Sept. 14, DDMAC Branch Chief No. I Director Leah Palmer said that citations for off-label use represent only 13% of her division's 64 untitled and warning letters issued from Oct. 1 through June 30.

Though small, it is up from the 10% of citations concerning off-label use for the same period in FY 1998.

By far, the biggest DDMAC concern is fair balance in ads, Palmer said.

She noted that of the 64 letters, 61% addressed fair balance, up from 50% in fiscal 1998 (See table).

DDMAC Untitled Letters Citations Fiscal 1999 vs. 1998 (1st three quarters)

Fair Balance 1999-61% 1998-50% Unsubstantiated Safety & Efficacy (S&E) Claims 1999-36% 1998-26% Off-label use 1999-13% 1998-10% Comparative S&E Claims 1999-11% 1998-6% Superiority S&E Claims 1999-9% 1998-17% Source: Leah Palmer, DDMAC-FDA Palmer said fair balance deficiencies include "failure to provide adequate risk information." Noting that FDA is very concerned about risk management, Palmer said that drug manufacturers can expect to see more DDMAC oversight of advertising that plays down risks but overly promotes the positive facets about Rx drugs.

The Center for Biologics has issued its share of promotional citations too, despite having fewer people than DDMAC and a broader array of industries to regulate (blood, plasma, drugs, devices, vaccines).

From the start of the current fiscal year (Oct. 1 through Aug. 31), CBER received 74 complaints that yielded one warning letter, 29 untitled letters and 23 situations that were "resolved by phone," said Carol Broadnax, a regulatory review officer in the Center's Office of Compliance and Biologics Quality. Broadnax said 14 cases are still pending, three were forwarded to DDMAC and four were deemed merit-less.

Among the untitled letters, 15 concerned false and misleading infor mation, seven dealt with pre-approval promotion, two concerned blood donations and five were for off-label promotion. Hence, fair balance was not an issue among the untitled letters.

The two concerning blood donations involved cases where blood banks used financial incentives to woo donors, including tickets to St. Louis Cardinals baseball games. Broadnax said CBER made the blood centers relabel the products to note that the donors had been paid She said blood banks cannot use any promotion to attract donors that can be redeemed for money.

However, items that cannot be cashed in are allowable and still render the donation "voluntary."

Devices were among the untitled letters, Broadnax said. One company, for example, was slapped for promoting its "quality system," she said -- probably among the few cases where GMPs and advertising issues have crossed paths.

The Center for Devices provided no statistics on warning and untitled letters, but Deborah Wolf, an attorney with the Center's Promotion and Advertising Policy Staff, said "we probably issue more warning letters than DDMAC."

Like the Dey Labs' letter, Wolf defended a citations by her group for Prosurg's claim that a product could make ethanol to treat prostate cancer. "This is not what the device was approved for, and we felt it was a drug claim," Wolf said. "We feel this was consistent with the WLF decision."

Palmer defended the Dey Labs untitled letter on grounds that the firm was promoting Atrovent for having a special preservative. Palmer said the drug "has never contained this preservative, and the company knew the distinction, decided not to clarify this misleading message, and distributed this reprint without communicating this."

Palmer added: "I want to emphasize that we carefully evaluated the reprint and we believe the action we took is consistent with the judge's order and not in conflict with the WLF decision."

Sincerely,

The Editors The Palmer/Broadnax outlines, including sample warning and untitled letters and advertisements, is $20, Doc.

8016W. A presentation about animal drug promotion is $7, Doc. 8017W, and another concerning direct-to-consumer ads is $3, Doc. 8018W. Retrieval is extra and is added per order, not per document.