Advertising letters down 50% from FY '01; FDA vows more actions in '03.

But ad staff increases at CDER, CBER 

Dear Reader,

The Center for Drugs and Center for Biologics issued only 34 warning and untitled letters in fiscal year 2002 (ended Sept. 30), down about 50% from 2001.

The decline has been expected ever since March when FDA Chief Counsel Daniel Troy started requiring all warning and untitled letters to be reviewed by his office. The policy was instituted by the Department of Health and Human Services in December 2001 to ensure consistency and to prevent warning letter inflation.

However, critics, notably Public Citizen Health Research Group and Democrats in Congress, have said Chief Counsel review has delayed FDA's ability to act quickly on misleading drug advertising and other enforcement issues.

Addressing a Drug Information Assn. conference in New York Feb. 24, Tom Abrams, director of CDER's Division of Drug Marketing, Advertising and Communications (DDMAC), said: "We sent out about 30 letters last year. I want to see more letters sent out, but even more than that, I want to see less violations."

According to 2001 data, DDMAC's untitled letters alone totaled 66 in fiscal 2001.

CBER, which has always had a smaller presence on the advertising scene, issued just four untitled letters in 2002, said Glenn Byrd, director of the Center's Advertising and Promotional Labeling Branch (APLB).

While the Center for Devices disbands its Promotion and Advertising Branch in the Office of Compliance, Byrd and Abrams said their respective divisions are getting new staff to oversee advertising, particularly direct-to-consumer (DTC) ads.

Abrams said DDMAC plans to increase staff as a result of extra money allocated by Congress. Instead of one DTC review group, for example, there will be two. Other organizational changes are also under way.

Looking back over 2002, Abrams said the most common violations cited by DDMAC were the minimization of risk information, overstatements of efficacy, broadening the approved indication or target population of a drug, and unsubstantiated comparative claims.

But Abrams said the new advertising "Code of Conduct" issued in July by the Pharmaceutical Research & Manufacturers of America (PhRMA) has had tangible changes in the nature and type of violations coming through his office.

"We've seen less giveaways and less 2253 violations," Abrams said, referring to Form 2253, which makers of new drugs submit for their initial ad campaigns.

"Obviously, we're looking at the content of a promotion, not the types of gifts given out." The Department of Justice will be looking at those, he said.

Going forward, Abrams defined the three main priorities of DDMAC to be: the monitoring of DTC advertising, issues related to the launch of new products, and regulatory violations.

"Our highest priority will be reserved for serious safety risks and violations," he said, adding that the division receives more than 200 complaints per year. Each one is reviewed, and officials try to acknowledge each one within 30 days of receipt, during which time it is decided if the complaint has merit.

"If a complaint is deemed to have merit, it is prioritized according to the seriousness of the violation," he said, "and our definition of seriousness may be different than a company's definition. If one complaint is a competitive issue and one is a safety issue, the safety issue will be addressed first."

Byrd said APLB staff increased from three people to six since Byrd's appointment in April 2002.

"If you're involved in drug approvals, I urge you to look at the letters posted on our site," Byrd said. "It's not enough to do just that, but it's a good starting point."

Byrd said a number of changes are underway at CBER, such as the establishment of the Office of Cell Therapy, Tissues and Gene Therapy. The group has also become increasingly involved with bioterrorism/counterterrorism products and activities.

He said APLB is still part of CBER's Office of Compliance and Biologics Quality, despite the pending reorganization of the two centers. FDA implemented on March 17 the third phase of the consolidation of CBER/CDER review functions by transferring more than 200 CBER staff to CDER.

"There is nothing definitive to date," Byrd said. "APLB is still part of the CBER Office of Compliance." He went on to say that "therapeutics is only a small portion of APLB's work," noting the staff also is responsible for vaccines, blood, gene/cell therapy and biologic devices.

"Do not change where you send your materials until you are formally notified by FDA," he advised.

Sincerely,

The Editors

The Byrd and Abrams handouts are available for $15 plus retrieval, Doc. 12283W.