FDA DRUG AND DIVISION's NEW ACTING DIRECTOR IS ANN WITT, ON TEMPORARY ASSIGNMENT FROM GENERAL COUNSEL OFFICE, COMMISSIONER KESSLER TELLS KENNEDY HEARING

Executive Summary

FDA is temporarily reassigning Associate General Counsel Ann Witt to serve as the acting director of the agency's Drug Advertising and Labeling Division, Commissioner David Kessler announced at a March 6 oversight hearing before the Senate Labor & Human Resources Committee. Noting FDA's concern with "violations of the FDA regulations governing prescription drug advertising and promotion," Kessler said Witt "has agreed" to "come in and help turn this situation around." FDA must "act swiftly to stop the escalation" of promotions intended to mislead the public before they "result in the kind of chaos that we saw recently with health claims on the food label," Kessler declared. He acknowledged that "most firms in the industry want to adhere to our regulations, but they are waiting for us to take the appropriate actions" against companies that "have gone over the line." Without taking firm punitive action against violators, "there is not a level playing field out there," Kessler declared. Cheryl Graham, MD, will join Witt in the division as interim deputy director, Kessler said. Graham is "a medical officer with regulatory and scientific experience in FDA," he noted. Most recently she was deputy director for the Cardio-Renal Division. The Drug Advertising and Labeling Division has not been headed by a physician since its director was Peter Rheinstein, who also is a lawyer. Witt and Graham, "with their strong legal and scientific background, together will provide a combination of expertise that has not previously been available within this division," Kessler said. The commissioner also reiterated recently announced plans to double the division staff "with the addition of 10 new people." FDA also is reviewing the FD&C Act to determine whether the advertising provisions should be strengthened, Kessler continued. "We need to look hard, collectively, to see whether the agency requires new authority, and we have already begun this process internally," he said. "The statute is broad in this area and gives us the ability to deal with the most egregious cases. However, the law was written at a time when no one could anticipate the types of promotional activities we are now seeing." Asked by Ranking Minority Member Hatch (Utah) about user fees, Kessler asserted that there is "no other way" for FDA to receive adequate funding. "The magnitude of the resources the FDA will need . . . over the years will be significant, and I know of no other way to do it than user fees," the commissioner said. In phrasing the question, Hatch noted that he had previously "strongly opposed user fees -- especially if [the resulting revenues] are not dedicated to the FDA or if they supplant funds that are currently appropriated for FDA." Answering his erstwhile boss, Kessler said he has "thought long and hard about that question." After considering "the resources the agency has" and "all the tasks before us," the commissioner concluded that user fees are necessary. "I come from a hospital that had a budget about the same as the FDA's and . . . [the hospital] only had to worry about a portion of the problems." The new commissioner also declared that strong enforcement requires apportioning the lion's share of enforcement resources to the field. Freshman Sen. Wellstone (D-Minn.) asked what FDA can do "to reverse the trend" in enforcement. Kessler replied that the "most important thing that we can do to reverse that trend is to pay attention to our field resources." Therefore, the commissioner said, in "our 1991 budget, our 1992 request to the Congress, over 50% of the money that's being requested is going to be dedicated to the field." Kessler noted that he has "met with all the regional directors as of two nights ago" and has visited three of the regional offices and will travel to a fourth "soon." He said he "told them in no uncertain terms that I want them to have access to me." Kessler added that "there's nothing worse than recommendations coming into the headquarters that don't get acted on expeditiously." Rep. Dingell (D-Mich.) held a hearing the following day on FDA's failure to act on field investigators' recommendations for regulatory actions against generic drug firms (see stories on pp. 9-11).