FDA Ad Division Adds Third Enforcement Branch Headed By Askine

FDA's Division of Drug Marketing, Advertising and Communications has added a third Enforcement & Review Branch headed by Branch Chief Mark Askine.

A former Giant pharmacy manager, Askine joined FDA about four years ago as a member of the Center for Drug Evaluation & Research's Drug Information Group.

The new branch was established in April after the number of primary reviewers had increased to 14, requiring the supervision and guidance of an additional branch chief, DDMAC explained.

Other recent ad division changes include the March appointment of Janet Norden to acting chief of Enforcement Branch II, replacing Tracy Acker.

Norden joined FDA in June 1997 as a reviewer in the Division of Cardio-Renal Drug Products. She is a pediatric nurse with some experience in industry as well. Leah Palmer is chief of Enforcement Branch I.

The enforcement branches are responsible for issuing warning and untitled letters as well as responding to sponsors' requests for comments.

The increasing pace of product approvals under the user fee system as well as the expansion in direct-to-consumer advertising efforts has expanded the division's workload.

DDMAC also includes an evidence review branch (which oversees FDA Modernization Act information dissemination rules and quality of life issues) and a research and review branch (which works on direct-to-consumer ads, patient information and labeling).

The chief of the evidence branch is Laurie Burke and the chief of the research branch is Nancy Ostrove.

Speaking at the May 11-12 Healthcare Marketing Coalition prescription drug marketing conference in Basking Ridge, N.J., former ad division Director Lucy Rose said that response times from FDA to sponsors seeking guidance on promotions have increased. Rose is now president of an independent consulting firm, Lucy Rose & Associates.

A combination of "significant turnover in DDMAC" and the increasing workload for the division "has served as a funnel effect to slow some of this down," Rose maintained.

The third review branch represents an effort "to try and help augment this training [of new reviewers], make it quicker and...reduce some of the funnel effect."

While establishing three branch chiefs may decrease the workload under each one, it also may create "consistency concerns" over the uniformity of ad division reviews, Rose pointed out.

"There is a lot that they are trying to deal with right now with trying to meet some of these needs with fairly fixed resources," Rose added.

DDMAC's goals are to review launch materials for new products within three weeks and broadcast ads within four weeks. While the division said it usually meets these goals, sponsors often argue with or are confused by aspects of the division's review.

"The reality is the first review may take place in 3-4 weeks, [but] in general, there are negotiations and it seems to be taking 10-12 weeks," Rose said.

DDMAC acknowledges that the negotiation process could be improved, suggesting that teleconferences could serve as a potential vehicle to a more productive exchange.

In an effort to reduce the number of steps in the review process, DDMAC has recently focused on making letters to sponsors clearer and more understandable. The division has also urged sponsors to be more specific in responding to DDMAC reviews.

The division is also hoping to eliminate unnecessary steps in the review process by developing a draft guidance for industry on how to submit promotions for review electronically.

As part of a pilot program, sponsors have started to present materials electronically, allowing DDMAC to simultaneously review the submission on paper and in electronic form.