FDA COM. YOUNG IS FIGHTING PUBLIC PERCEPTION OF "WEAK" AGENCY, INEFFECTIVE MANAGEMENT; DINGELL SAYS ON McNEIL/LEHRER HE WANTS "PHILOSOPHICAL CHANGE"

Executive Summary

Rep. Dingell (D-Mich.) is looking for a "philosophical change" at FDA to make the agency a more vigorous and adversarial enforcer of its regulatory authority. Behind the lax generic approval procedures at the center of the current investigations, Dingell sees an agency management committed to voluntary regulation. "Quite honestly," the Michigan Democrat declared in an Aug. 23 appearance on the PBS TV McNeil/Lehrer Newshour, "this all occurred against a background in an administration which sought to deregulate -- which believed in the kind of regulation that Dr. Young would like to see." Dingell's condemnation of the agency management and philosophy is important as a key determinant in the ultimate effect of the generic drug investigation on the FDA and Commissioner Young's tenure at the agency. The public image conveyed by Dingell's subcommittee through the media will play a large role in whether HHS and the White House will be forced to seek changes at FDA. As the story of the generics investigation has peaked in prominence in the national media, it is being portrayed frequently as an inefficient management story -- the type of story that, in Washington, frequently leads to an agency scapegoat. The generics investigation first moved to the front pages of the national print media in The Washington Post and The New York Times during the week of Aug. 13-19 and spread to TV and radio during the Aug. 20-26 period, culminating in an Aug. 25 front page headline in USA Today -- "'Weak' FDA Caused Drug Scandal." Health Research Group attorney William Schultz made the charge against Commissioner Young explicit in an Aug. 23 talk show on a National Public Radio affiliate station in Washington. On WAMU's "Mike Cuthbert Show," Schultz attributed a pattern of lax agency regulatory actions directly to the commissioner. "I could go through a lot of areas where the FDA has been very lax; it's really a philosophy that the agency has adopted under Frank Young of what he calls voluntary regulation." Calling for a management change at FDA, Schultz said: "I think the only answer is going to be for some change of leadership at the FDA, somebody who could convince the general public that FDA is actually doing its job and that generic drugs are safe." However, Schultz acknowledged Young's longevity in Washington. "If he doesn't keep his job," Schultz commented, "and I suspect he may lose it, it won't be for lack of trying." During his five years in Washington, Young has shown unusual skills as an energetic and resourceful defender of FDA and deflector of criticism aimed at himself. Young is continuing to fight gamely in the current PR stuggle. Appearing with Dingell on the McNeil/Lehrer Newshour, Young praised Dingell's investigation several times and gave the committee credit for pointing out the irregularities in the generic division to the agency management. Young maintained that FDA was kept out of the investigations and learned of many of the specifics through Dingell's subcommittee. "We were asked to stay out of this and not to interfere and we really got the information when Mr. Dingell brought it to our attention through the hearing process," Young told PBS correspondent Judy Woodruff. "I want to compliment [Rep. Dingell] very strongly for a good bipartisan work," Young said. "And as we got the information on this we have gone vigorously into action." In response to a question from Woodruff on when he first thought the generic process was in trouble, Young said: "I knew we had a serious problem when Mr. Dingell's investigation started and there was a real move to investigate one particular person." Young noted that the agency had tried to carry out its own investigation at the start, "regretfully without having quite the tips that Mr. Dingell had and the Inspector General had." Dingell began his response by returning a short compliment to Young. "Before I start in," Dingell said, "I would like to say that I have a great deal of respect for Dr. Young." That acknowledgement out of the way, Dingell quickly went on: "Having said that, I have to say that there are great problems here and they take many forms." To staunch the bad headlines and get the agency's story across, Young faced a group of about two dozen Washington health reporters at a breakfast meeting on Aug. 24. Young noted to the reporters that the agency was limited to a paper review of generic applications by the Waxman-Hatch Act. The post-1962 ANDA review process "is a system that was brought forward at the recommendation of those who wrote the law that it be a paper review. We do not have the authority to do in-house the check of these kinds of things" regarding bioequivalency evidence, the commissioner explained. He also illustrated the agency's resource problems by relating an anecdote about a trip he took the day before to the agency's busy Brooklyn District Office. "When I went to Brooklyn," Young said, "there were a number of TV cameras there," and "I made a Faustian bargain with them. I said, 'Please, just do me one favor . . . take a picture of the outside of the building." Young implied that the building is a visual metaphor for the resource stress on the agency. "Around the building is a four-foot, heavy net -- a wire mesh," he said. The net is there "because [the building] is an old warehouse, a converted warehouse, and the building is falling down. The net is there so that when you walk in the building, you don't get hit by concrete . . . when you look up on the net, there are large chunks of concrete." The FDA commissioner also used the meeting with reporters as a chance to heap praise on one of the agency's recent press critics, a new health reporter for The Washington Post, Malcolm Gladwell. Referring to a background piece in the August 21 edition of that publication on bioequivalence, Young said "that was the best article I've ever read in a lay paper describing the very complex science" involved in bioequivalence testing. "That was a truly excellent article." The commissioner went as far as to ask Gladwell to autograph a copy of the article for him. At another point during the breakfast meeting with reporters, Young told Gladwell: "As you said very strongly in your article, it is not just important to get the active ingredient, but [also] the inactive ingredients are going to be of marked importance as to whether the drug gets into the bloodstream in the right concentration." Young singled out the Post reporter one day after that paper commented on the FDA situation on the editorial page. Young did not fare well in that treatment. "Congressional investigators have contended that FDA Commissioner Frank E. Young did not react aggressively enough when they originally raised this issue," the Post editorial intoned. "Until recently," the Post continued, "Dr. Young had been saying that the improprieties seemed to be confined to a few isolated cases. It isn't merely that this rankles Capital Hill investigators; failure to act can seriously erode consumer confidence in the FDA -- and with reason." The editorial concludes with a jab at current FDA management, stating that whatever the results of the current effort to test the top 30 generic drugs, "they won't prove that all is well within the FDA. Too many questions have been raised." During the current headline crisis, Young is a bit short in experienced staff support at FDA. The agency, for example, has a new Associate Commissioner for Public Affairs, Jeffrey Nesbit, who is having to learn about agency operations during an intense period of outside scrutiny. Nesbit joined the agency this spring after two years of work with Vice President Quayle in the Senate and during the presidential campaign. He has seven years of experience as a reporter for a series of newspapers, including Knight-Ridder and a stint with syndicated columnist Jack Anderson, prior to working for Quayle. Nesbit's journalism background may be helpful in relating to the lay media. However, he apparently embroiled the agency in an unnecessary expansion of media attention with comments to a USA Today reporter on Aug. 22. That mass circulation paper headlined the next day that the generic investigation was extending to a major brandname company. The FDA public affairs official reportedly commented incautiously that a brandname company was being inspected for alleged quality control problems and not application fraud. His comments are said to coincide with an FDA inspection of Lilly in relation to a recall of thyroid products and 11 vitamin and mineral products by that firm in June (see related T&G). FDA investigators have said that the inspection has nothing to do with the generics investigation.