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SEN. HATCH, REP. DINGELL ASK FDA FOR SIX-MONTH GENERIC DRUG REVIEW "MANAGEMENT PLAN"; FDA SHOULD BE ABLE TO REVIEW 20-25 ANDAs PER MONTH, CONSULTANT SAYS

Executive Summary

FDA should draw up a six-month "management plan" as a blueprint for its measures to correct the agency's generic drug regulatory procedures, Sen. Hatch (R-Utah) told a June 5 House Oversight Subcommittee hearing. The ranking minority member of the Senate Labor & Human Resources Committee asked the Oversight Subcommittee to "join me" in pressing FDA for "a management plan which is to be implemented in six months." Hatch said FDA should be pushed into a reform of its generic drug regulatory activities by the threat of further congressional action. If FDA cannot correct its deficiencies itself, Hatch said, then Congress should do it for the agency. If the agency can develop a plan, then Congress should monitor it closely, Hatch said. "If it doesn't work, we in Congress must take draconian steps to improve the way the generic drug [office] does its business." Hatch did not elaborate on the "draconian steps." However, as an author of the Waxman/Hatch Act, which authorized the current system of generic drug reviews, Hatch may be indicating a willingness to reopen and revise that law. Maintaining that he would prefer not to have to seek a Capitol Hill solution to FDA's generic review problems, Hatch declared: "I'd like FDA to clean up its own act." Oversight Subcommittee Chairman Dingell (D-Mich.) replied that he will request his staff to work with Hatch's "to draft that necessary letter to FDA." Hatch's strong statement at the Dingell hearing appears to buy FDA a period until at least the end of this year to straighten out its generic review process. Hatch's language sounded threatening to FDA, but it appears designed to give the agency a little more time to clean its own house. With the imminent departure from Dingell's subcommittee staff of David Nelson, FDA may actually get a little more breathing room to make its own changes to the generic program. Nelson has been the key legislative investigator into the generic drug industry (see related item, T&G-2). The generic drug problems, Hatch maintained, can be blamed primarily on FDA's failure to enforce the existing laws. "The Waxman-Hatch legislation is a strong statute and the congressional mandate is remarkably clear," he said in prepared remarks. "Had the FDA acted prudently, responsibly and with authority granted to it by Waxman-Hatch, there would have been a set of regulations promulgated that would have established standards from which it would have been virtually impossible to deviate. Instead, because of the inaction by FDA, we have the corruption and scandal that has led us to this hearing today," Hatch charged. Hatch has introduced a Senate companion bill (S 1164) to the generic drug debarment bill sponsored in the House (HR 2454) by Dingell and Rep. Bliley (R-Va.), the subcommittee's ranking minority member ("The Pink Sheet" May 27, p. 3). The senator illustrated the dearth of generic drug approvals with a chart indicating that in 1986, 1987 and 1988, FDA approved 720, 713 and 684 generic drugs, respectively. In 1989 and 1990, however, the number of generic approvals fell to 265 and then 60. American Pharmaceutical Association Scientific Director Arthur Kibbe, PhD, testified that an efficient agency with current staffing should be able to approve an average of 20-25 generic drugs per month. "This productivity level, although far below the record of 600 per year in the days prior to the scandal, would ensure the American public a steady supply of quality generic drugs." Kibbe added that the current average time required for FDA to review generic drugs is more than "30 months, which is longer than the average time it takes an NDA review." Kibbe was one of three members of a panel of consultants hired by FDA to determine whether FDA had retaliated against certain generic companies. The three consultants testified at the June 5 hearing. Hatch asserted that "10 major" pharmaceuticals "will be coming off patent this year" and represent "billions of dollars." Consequently, "if we've got to wait 30 months to get those approved, we lose about $ 2 bil.," he said. "It's pathetic, and this is the senator talking who authored the FDA revitalization bill, and all of us agree that [the agency] needs to be revitalized." However, Hatch continued, "I agree with" Rep. Wyden (D-Ore.), who commented that additional personnel, facilities and funding will not correct "this mess" without strong and fair leadership. In an opening statement, Wyden pointed out that "virtually everyone" agrees that FDA "needs more resources, more money and more staff." But, he commented, "I think it's time to face reality, and that is that the FDA isn't even spending efficiently the dollars that it's getting right now." Wyden maintained that "a big source of the problems" at FDA "was the deregulation frenzy" of the mid-1980s. "It's important to note that a number of the problems that we have seen had nothing to do with that statute," he maintained. The "legislation did not mandate, for example, that there be a 10% reduction in enforcement at FDA, which is what we had in the mid-1980s," he said. Neither did the act mandate "that the FDA not follow up on tips of questionable behavior." Another member of the FDA "retaliation" panel, HHS Inspector General Office Special Agent James Kopf, contended that Center for Drug Evaluation and Research Director Carl Peck, MD, and Deputy Director Gerald Meyer exhibited an "attitude" toward the generic drug industry. The IG agent maintained that the senior managers created an atmosphere that is counterproductive to fair and timely reviews of marketing applications. Asked by Wyden if anyone in the FDA hierarchy exhibited "inconsistent" regulation of the industry, Kopf testified that "Dr. Peck and Mr. Meyer would fall into this category." Kopf said the FDAers exhibited an "attitude" that companies "have to do it our way and the hell with the industry, and if a company is going to be inspected, it's going to be inspected." Another retaliation panel member, pharmaceutical chemistry consultant John Zarembo, PhD, agreed: "It appears to me that there were cases where these two people could have moved to expedite [reviews] and to treat people fairly, but I don't think that those steps were being taken." For example, Peck and Meyer established "no programs that would have moved toward improving the whole drug process," Zarembo said. "There was no indication that they were going to do that." Peck, Meyer and Generic Drugs Office Director Roger Williams, MD, attended the Dingell hearing but were not called to testify because the hearing was cut short so that subcommittee members could participate in debate and voting on the House floor. Peck's written testimony asserts that the agency is considering or implementing many of the recommendations of the three consultants. Dingell told Peck, Meyer and Williams that the subcommittee will submit questions for the FDA officials to answer in writing. Reportedly, the subcommittee plans to give them the option to return and answer the questions orally with Commissioner Kessler who has been invited to a hearing scheduled for July 11. Despite their criticisms, Kibbe, Kopf and Zarembo agreed that they did not find evidence of FDA retaliation against Mylan and Barr, two "whistleblower" companies. Kopf asserted: "I think there is [discrimination] against the entire industry, as opposed to any one company." Kibbe said the consultants found "a lot of instances where companies were disadvantaged one way or another, but" not only the whistleblowers were adversely affected, "those kinds of problems impacted the top 20 or 30 companies." Rep. Eckart (D-Ohio) asked how a "company with the most deficiencies was inspected the least amount of times," if there was no bias. Kopf replied, "There's really no explanation that we received." However, he said, the root problem is that "their inspection policy, the reasons for going out [to inspect firms] are a little bit vague and varied. A lot of times they claimed the fact that they're low on staff or that a particular region is inundated with generic houses and another region is not. It goes back to the basic inspection policy, which should be totally reviewed." Zarembo testified that FDA officials must bar "podium policymaking," in which agency policy is announced by agency staffers in speeches during industry meetings. The practice "is very widespread," the consultant said, and it is "very damaging because [a speech by] an FDA official at a meeting is regarded as law." When policy has been announced outside of statutory or regulatory authority and separate from guidelines, "it appeared to be arbitrary rulemaking by the individual," Zarembo said. "Every policy that is given at meetings should be reviewed and released by the appropriate FDA official," he contended, adding that "I don't think" corrective steps have been taken. In written testimony prepared for the hearing, FDA's Peck announced that the agency is "developing a new post-approval program that will combine a good manufacturing practices [GMP] review with heightened focus on reliability of company records." The program is designed to collect and analyze generic products in the marketplace "to ascertain compliance with compendial specifications and ANDA commitments, as well as to identify unapproved changes in formulations that could affect product performance." Many of the suggestions from Kibbe, Kopf and Zarembo "reflect initiatives already under way," Peck maintained. He added that "Dr. Williams and members of his staff met with Dr. Kibbe and Dr. Zarembo last week to exhange information and perceptions about how best to resolve ongoing management issues in our Office of Generic Drugs." An example of recommendations FDA is "considering" is "a pilot bar coding system to monitor the flow and location of applications used in the review process," Peck said. Dingell noted that there seems to be "a growing internal philosophical disagreement regarding standards and protocols in the Division of Bioequivalence." He asked the consultants to explain reasons for the slowdown of approvals and the role of bioequivalence review. Kopf replied that "there were two lines of thought that were going on. In the bioequivalence area, they have more of a pro- approval approach, whereas in the scientific area, it's more of a conservative approach." For example, he said, "Dr. Peck's re- review of already approved data didn't make any sense and really slowed down the process with duplicate work at that point." Kibbe also testified that FDA offers "no formal training program" for its review chemists. "They get on-the-job training, [and] the Office of Generic Drugs has seminars on particular areas of concern [found in actual reviews], and they have just recently established a training branch" to design formal training programs, he said. "But right now no formal training programs with measurable outcomes.
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