New Commissioner Vows to Restore Integrity to FDA

The new commissioner of the Food and Drug Administration told members of Congress on Wednesday that his first priority will be to restore the integrity of his beleaguered agency.

“The FDA is on the move,” said Dr. David A. Kessler, outlining his agenda during his first public appearance on Capitol Hill. “We have vigorously begun our work. . . . We are building the momentum that will sustain us in the months and years ahead.”

Kessler, a pediatrician and an attorney, said he intends to protect against future abuses by revamping the ways in which the FDA reviews the data upon which it bases its approval of various products.

“The lesson the last several years have taught us is that it is imperative that we audit the data . . .,” he told the Senate Labor and Human Resources Committee. “We have found fraud and misleading data, and it is possible that these practices are more widespread than we thought likely.”

Kessler said he also plans to strengthen the FDA’s enforcement and surveillance programs to safeguard against the type of scandal that shook its generic drugs division last year. A federal investigation found that several FDA regulators had taken bribes from officials of generic drug companies in exchange for hastening the approval of their products. Five FDA employees have been found guilty, and four firms and eight drug company executives have pleaded guilty to making the payoffs. Others are still under investigation.

“I believe the generic drug situation occurred because people . . . thought they could get away with it,” Kessler said. “We are enhancing our efforts in this area by hiring additional criminal investigators, providing more training for all investigators, streamlining our enforcement procedures, and having FDA headquarters pay more attention to field activities,” he added.

The new FDA chief was sworn in last week and was confirmed by the Senate before it adjourned last year, but he did not have a confirmation hearing. At the time, he promised to appear before lawmakers to discuss his objectives for the agency.

Before coming to the FDA, Kessler was director of medicine at Albert Einstein College of Medicine in the Bronx.

In outlining his objectives Wednesday, Kessler said he also hopes to bolster the agency’s surveillance activities in such areas as medical devices; inspections of imported products, which have tripled since 1970 and which “tend to have more violations;” and in food products where there can be problems with disease-causing organisms, such as salmonella.

He added that he wants to find ways to manage the growing volume of applications for such items as new drugs, food additives, and blood bank licensing. Currently, he said, the agency “is not adequately prepared to meet the anticipated demand of new applications.”

He said he was also concerned about violations of FDA regulations that govern prescription drug advertising, saying “it is clear to me that some in the prescription drug industry have gone over the line.” Consumers are being “misled” by some promotions, he said, and “unless we act swiftly . . . they will almost certainly result in the kind of chaos that we saw recently with health claims on the food label.”

Kessler acknowledged that his program was ambitious, saying: “We have a lot to do here. It will take my entire tenure, and it will go beyond one commissioner.”