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FDA CAN REVIEW "QUALITY" NDAs IN 180 DAYS, FDA’s PECK TELLS LASAGNA COMMITTEE; FDA AND NCI RELATIONS HAVE IMPROVED, FDA/NIAID COOPERATION IS NEXT

Executive Summary

FDA is emphasizing "quality" NDAs and will refuse to file those that do not meet the agency's standards, FDA Center for Drug Evaluation and Research Director Carl Peck, MD, told the April 10 meeting of the National Committee to Review Current Procedures for Approval of New Drugs for Cancer and AIDS (the "Lasagna Committee"). "Increasingly we're turning back NDAs that don't meet [our quality] standard and I'm going to insist that my staff do that because it is basically a waste of our time to be dealing with sick NDAs," Peck told the committee. He described the "sick NDAs" as applications that are "poorly organized, poorly presented, [or] incomplete in terms of clinical trials not having been either implemented or analyzed" properly. Poor quality NDAs are "one of the more common reasons for so-called delays at the agency," Peck declared, telling the committee that he thinks FDA can meet its 180-day statutory deadline for NDA review "if we receive reviewable and complete NDAs." The FDAer made his remarks at the 10th and final meeting of the Lasagna Committee. In its previous meetings, the committee has generally focused on ways FDA can improve the review/approval process for AIDS and cancer therapies. This final meeting was requested by FDA to discuss areas for improvement on the sponsor side of drug development. The committee is expected to issue a final report from its meetings in May or June. In addition to disorganized and/or incomplete NDAs, Peck pointed to a number of other problems in drug development: Not all sponsors inform the agency of their drug development plan, depriving sponsors of the agency's advice. The persons responsible for the drug development plan are not always clear in situations where government, industry and academia are collaborating in the development of a therapy, "and when things fall through the cracks it's difficult to identify a responsible person." Sponsors "routinely" move "to the next clinical trial without completely analyzing the results of the most recent clinical trial." Peck noted that he "can't cite a model sponsor yet who is committing the necessary resources and energy to analyzing the results of their trials in an effort to maximize the information gain that would yield the most efficient drug development process and that would give us the kind of information that would be necessary to evaluate it in a timely fashion." Sponsors sometimes engage in a "de minimis" approach to drug development, "doing as little as possible from our point of view to get a drug approved." Resources are being wasted on studies that do not contribute to the knowledge base or the review process. Peck also cited industry "game playing" as a problem in drug development. "We know that sponsors practice their presentations before they get to see us and deliberately try not to present certain kinds of data to us in a foolish attempt to think that we do not have the penetrating scientific inquiry that will uncover that. It promotes a very serious inefficiency in our dialogue with them," he said. The "most egregious tack a sponsor can take," Peck continued, "is to send their regulatory affairs [people] with only a legal background in to talk to us, because without the scientist dialogue we really can't come to grips with the scientific issues." * While many of Peck's remarks appeared equally applicable to areas outside of cancer and AIDS, he specifically commented that it has been much easier to work with the cancer community than with the AIDS community. Noting that there is greater experience in the cancer field and that FDA's "advice is accepted more often," Peck said that "in the AIDS area we're amazed at times at how we have to wrangle with all parties on simple things like getting the dose regimen, using body weight to determine a dosage, and working on the kinetic and dynamic concepts." Elaborating on drug development problems in the AIDS area, FDA Anti-Viral Drug Products Division Director Ellen Cooper, MD, reported that one of the difficulties is a lack of communication between FDA and the National Institute of Allergy and Infectious Diseases. "The AIDS program leadership at the NIAID appears to be pursuing a course of distancing themselves and the ACTG [AIDS Clinical Trial Group] investigators from the FDA, which unfortunately has resulted in less interaction and information exchange rather than working to build consensus and define more clearly the separate but complimentary roles of the NIH and the private sector group sponsors," Cooper said. The apparent lack of communication between FDA and NIAID concerned the committee members, who had focused a number of their early meetings on improving the relationship between FDA and the National Cancer Institute. Both FDA and NCI report that relations have improved in the last year, partly as the result of a series of informal meetings between the two agencies. FDA and NIAID Division of AIDS Director Daniel Hoth, MD, agreed at the April 10 meeting that similar informal discussions should be held between FDA and NIAID to rectify a schism between those groups. Hoth suggested that one of the first topics for discussion should be the roles and responsibilities of NIAID, drug sponsors and FDA in the development of AIDS therapies. Cooper had cited role definition as one of the key problems in the development of AIDS drugs. She noted that at times NIAID "appears to want to substitute for the drug company sponsors, hold the INDs and be the primary decisionmaker, obtaining only the drug itself and occasional advice from the pharmaceutical company." At other times, she added, "NIAID seems to desire a more collaborative role, allowing the drug companies to hold the IND." Cooper maintained that the "fundamental responsibility for new drug development in this country remains with the commercial sponsors and therefore they should maintain their traditional role of being the primary decisionmakers despite the increased complexity of this task in the AIDS environment." * Several industry representatives were also invited to the Lasagna committee meeting to give their views on the drug development process. Among those presenting were Adria Labs Senior Director of Medical Research Richard Gams, MD, Lederle VP Robert Desjardins, MD, James Molt, PhD, from Merck, and Otsuka Pharmaceutical VP-Clinical Development (and ex-FDAer) Barrett Scoville, MD. Representatives from Besselaar Associates and Clinical Research Center also discussed their views on improving clinical testing programs. At several points during the meeting the committee discussed industry's perception that it will be punished for appealing a decision made by FDA and the apparent difficulty sponsors have in distinguishing FDA advice from mandatory requirements. In response to the suggestion that sponsors view FDA advice as a mandatory course of action, Peck maintained that many sponsors do not follow FDA's advice. "It's impressive how often our advice is just ignored," he said. FDA Office of Drug Evaluation I Director Robert Temple, MD, called the perception that FDA punishes sponsors for appealing a decision "a fiction." It "just takes a rather modest amount of courage," Temple said. "Anybody who leaves a meeting obliged to do something he thinks is stupid, and he's never even said so, is a wimp," he quipped.
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