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TPA DECISION BY FDA IS CLOSE, FDA COM. YOUNG INDICATES IN "TODAY SHOW" INTERVIEW: YOUNG's ATTENTION TO TPA HIGHLIGHTS MANGEMENT PROBLEM AND STYLE

Executive Summary

Genentech may have submitted enough data on TPA in the six weeks since the May 29 Cardio-Renal Advisory Committee review to permit a final FDA decision on the product license application (PLA). FDA Commissioner Young indicated FDA is near a decision during an interview on NBC's "Today Show" on July 15. "We've been able to, in the last month, gather most of the data that's enabling us to come to a decision as to whether we can recommend approval or not with the next few weeks," Young told the NBC morning news show. Genentech has been submitting additional TPA data to the agency since the advisory committee's recommendation against approval. The firm said that by June 30, it had submitted specific data requested by FDA, and that it is continuing to submit additional information. The submission presumably includes closer analysis of data from a Johns Hopkins study detailing TPA's effect on left ventricular function. The advisory committee identified that endpoint as a basis for an approval decision. The NBC interview, in which Young was paired off against TPA-patient and talk show host Larry King, highlights two aspects of Young's role at FDA as he starts into his fourth year at the top of the agency. The public attention to TPA reinforces the importance of that decision to FDA public stature and internal morale. Young's willingness to go into a potentially hostile or unfriendly public forum to explain and defend FDA's actions is indicative of one of the prime characteristic of his tenure at FDA. TPA is the most visible, if not the most pressing, issue facing FDA. The agency's public detractors, including the editorial page of The Wall Street Journal, are making the agency's handling of the advisory committee review a rallying point for attacking FDA's approach to new drug reviews. However, that external criticism may also indirectly by pointing at one of the more significant management decisions facing Young this summer -- the choice of a new permanent director of the Office of Drugs & Biologics and an approach to maintaining the uneasy union between the two groups (drugs and biologics). The critics of the TPA advisory committee review portray it as an example of the overly rigid approach to efficacy by the old bureau of drugs NDA review group. They maintain that the old bureau of biologics group (with its cultural ties to NIH and drug development) would have been more inclined to approve the product if left alone to make the decision. The Wall Street Journal attempted to carry that theme by printing a transcript on July 13 of the end of the May 29 TPA advisory committee meeting. The meeting ended with a brief repartee between Office of Drug Research & Review Director Robert Temple and his counterpart in biologics, Elaine Esber. Temple noted that the biologics group is not obligated "to take the committee's advice." Esber replied, "That is right." A common hallway topic at FDA recently has been a re-division of the two groups back to the separate and unrelated status prior to the 1982 merger into the Center for Drugs & Biolgics. Top FDAers, however, indicate that it is unlikely that the agency will try to recreate the past. FDA Deputy Com. Norris has reportedly made recommendations to Young for the restructuring of the center. In his decision for a permanent director and the structure of the combined drug and biologics units, Young is faced with a opportunity to try to deal with any imagined or real culture clashes between the groups. While the move to blend the two groups may not have worked smoothly in the short-term on the TPA review, the agency will continue to face more types of reviews which will depend on the specific skills of both groups. The concept of blending the emphasis on efficacy review procedures of the bureau of drugs will the knowledge of purity and production issues for biologics appears to continue to make sense in the long-run. Center for Drugs and Biologics Deputy Director Paul Parkman, MD, took over the position as director of the Center on an acting basis after Meyer left the agency in October to head American Cyanamid's medical research division. Parkman is one of the lead candidates being considered to head the Center. The agency is reportedly down to a short list of four potential center directors: Parkman; FDA Blood and Blood Products Division Director John Petricciani, MD; National Cancer Institute Division of Cancer Treatment Director Bruce Chabner, MD; and Uniformed Services University of Health Sciences Clinical Pharmacology Division Director Carl Peck, MD. The internal management decision may be a tough call for Young; the effort to represent the agency to the outside world appears much easier to him. In his three years as Commissioner, Young has shown a distinctive style and skill at representing the agency publicly. For example, on the "Today Show," Young genially but forthrightly explained the agency's position on TPA when King attributed his own quick recovery from a recent heart attack to TPA. The commisioner has also defended the agency in less visible ways. He has reportedly continued to talk to his critics of The Wall Street Journal to try to tone down the paper's critical editorial series. He similarly has tried to maintain personal contact with Congressional critics of FDA and has shown an ability to roll with the punches on Capitol Hill, not letting criticism of the agency get to him personally. Capitol Hill sources indicate he is enjoying the job so much that he is beginning to let it be known that he would like to stay on after the 1988 elections no matter the outcome.
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