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FDA MOVING TWO DRUG DIVISIONS -- ANTI-INFECTIVES AND METABOLISM & ENDOCRINE -- FROM BIOLOGICS BACK TO CENTER FOR DRUG EVALUATION AND RESEARCH

Executive Summary

FDA's Anti-Infective Drug Products Division and the Metabolism and Endocrine Drug Products Division will be broken off from the Office of Biologics and incorporated into the new Center for Drug Evaluation and Research under the agency's split up of the Center for Drugs and Biologics, Commissioner Young indicated during an Oct. 20 press briefing. Young disclosed the return of the two review divisions to the drug review division in response to a question on the responsibility for AIDS drug reviews under the reorganization. Young said that some of the AIDS products currently in Biologics "are moving over to the Center for Drug Evaluation and Research." Young mentioned the two divisions being transferred by their directors, Solomon Sobel [Metabolism & Endocrine Drug Products], and Edward Tabor [Anti-Infective Drug Products]. "What we felt," Young explained, "was that the anti-infectives were more alike as a group of drugs then they were as a group of biologics." He emphasized that the movement of the two divisions "does not change the composition of personnel nor anything that we would do in regards to the support thereof." While the Center for Drugs ad Biologics is being divided into two separate entities, Young stressed that the two centers would be cooperating on key, overlap issues such as AIDS and biotechnology product review and regulation, including "biological drug" approvals. In the AIDS area, the two centers will be collaborating on the review of AIDS products through a formal AIDS program installed in the Center for Biologics Evaluation and Research under center director Paul Parkman, MD. Since the departure of Harry Meyer in late 1986, Parkman has served as acting director for the Center of Drugs and Biologics. Defining the AIDS product review responsibilities of the two center directors, Young noted that while new Center for Drugs Evaluation & Research Director Carl Peck, MD, assumes the "line responsibility" for AIDS drugs in the Anti-Infective and Metabolism & Endocrine divisions, "coordination of the entire AIDS program whether it be in devices, in drugs, in biologics, the representation of all this at HHS is Dr. Parkman." The press briefing and an FDA staff meeting were scheduled on Oct. 20 to formally introduce Peck in his new role. The director for the drugs center offically began his duties Oct. 19. Another area of shared responsibility between the two centers will be the evaluation of biotechnology-derived products, Young noted. In anticipation of more therapeutic product applications from recombinant technology, Young said he has asked Parkman and Peck to work together to develop a plan on how such "biological drugs" should be handled in the future. "What we will focus on as we deal with biological drugs is what falls into the category of biologics and what falls into the category of drugs," Young explained. "I cannot see how to do it correctly, so I have asked the two of them to bring me a plan and then I'm going to react to it." The commissioner noted that "there may be a need to develop biological drugs in both" centers or to "put them all in one organization." Young said the agency must "be prepared for what I think will be the largest growth area that has occurred since the advent of antibiotics -- namely, these variety of new biotechnology products primarily coming through gene cloning. I think [that] there will be a substantial number of monoclonal antibodies [and] that many of these are going to be derivative of proteins that are cloned. We have to be prepared for that and I am not prepared from a commissioner's level to divide this baby." Commenting on the most public example of a coordinated review between Biologics and Drugs, Young said he was generally satisfied with the review process FDA has followed with Genentech's Activase (tissue plasminogen activator). However, he stressed that TPA is "clearly a biologic" and, therefore, falls under the purview of the center for biologics. Biologics has had the final say on the application for TPA, Young explained, but two years ago they chose to seek a consultation with the the Cardio-Renal division in the office of drugs. "Once they got the consultation [from the drug division], the information went back to Biologics to be dealt with. I'm satisfied with that process in the sense of the generic issue of consultation from one division to another." Asked when a decision on TPA would be made, Young stated: "It's imminent." However, he pointed out, that technically the decision currently being considered is "whether we need more information or whether we can act." Young remarked that the TPA issue was "probably one of the more misunderstood legends." He says that he will continue to pursue the public debate on the issue and plans to write an article on it. In his address to FDA staffers, Peck stated how important he thinks research is for reviewers. Reviewers, Peck said, "must have a background in research at a minimum, for clinical matters, and at best they ought to have some current touch with these domains so they can relate to the current state-of-the-art competently." Serving directly under Peck will be Gerry Meyer, former associate commissioner for management and operations. Top management at the Office of Drug Research & Review was not affected by the reorganization with Robert Temple, MD, remaining as director and Paula Botstein, MD, as deputy director. Elaine Esber, MD, former director of the Office of Biologics Research & Review will serve as the assistant director under Parkman at the new Center for Biologics. Taking over for Esber will be James Bilstad, MD, former deputy director for medical affairs at the Office of Biologics Research & Review. Bilstad's deputy will be Gerald Quinnan, MD, the former director of FDA's division of virology. The Office of Management will be cut into separate offices under each center. The management office for the center for drugs will be headed by Robert Bell, former director of the division of Management Systems and Policy. Russell Abbott, Center for Drugs and Biologics Office of Management director, heads the office of management at the biologics center. FDA is understood to be considering a similar split for the Office of Compliance. Chart omitted.
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