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Executive Summary

CONTRACEPTIVE POSTMARKETING SURVEILLENCE SYSTEM should be set up to track both positive and negative health effects of drugs and devices, FDA's Obstetrics-Gynecology Devices Panel and Fertility & Maternal Health Drugs Advisory Committee recommended at a joint meeting June 14. "This is an area that has been allowed to deteriorate to a state of inadequacy for too long a period of time and it needs to be changed," said drugs committee member James Schlesselman, PhD, Uniformed Services' University of the Health Sciences, declared. The two panels agreed that FDA's current system of adverse reporting for all contraceptives is inadequate. The existing approach has "nothing specific for contraceptives," Bruce Stadel, MD, branch chief of FDA's Epidemiology and Surveillance Division, remarked. FDA's postmarketing set-up has a "very general scope," and "has neither the breadth nor depth to specific issues involving contraceptives," Stadel added. Setting up a new, tougher product tracking system, however, goes "beyond FDA with regard to its ability to solve" the problems, Schlesselman maintained. "I think the FDA needs support from outside of the agency in dealing with this matter." The committees suggested that one method of support would be "to develop an outside exemplary review group, like IoM, that would review postmarketing surveillance for FDA." Fertility & Maternal Health Drugs Advisory Committee Chairman Barbara Hulka, MD, University of North Carolina, applauded the concept of gathering positive postmarketing effects of contraceptive devices or drugs, Hulka said that "positive" is a "word we don't see in relation to postmarketing surveillance. That's a new concept when you think of adverse reports, which is sort of a minimal kind of postmarket surveillence." The two advisory bodies met in joint session to discuss six recommendations, including establishment of a comprehensive postmarketing surveillance system, floated by the Institute of Medicine in a recent report entitled, "Developing New Contraceptives: Obstacles and Opportunities" ("The Pink Sheet" Feb. 19, p. 4). The panels voted in support of five of the six IoM recommendations (see recommendations below). The one recommendation that was not embraced states: "The FDA should also be prepared to approve, in some circumstances, a new contraceptive drug or device that presents a risk if it is shown that the new contraceptive offers a safety advantage for an identifiable group of users when compared with that group's current actual contraceptive practice (including nonuse)." The panels were unable to arrive at a consensus regarding the recommendation, stumbling over IoM's use of the word "risk." Device panel chairperson Elizabeth Connell, MD, Emory University, added, "I find this [statement] rather cumbersome in a way. I can't see from a regulatory point of view how it would be feasible to introduce any procedure or drug or device that has substantial risk for a lot of people for the benefit of a small group, mainly because we know that labeling is not necessarily followed." CONTRACEPTIVE DEVELOPMENT RECOMMENDATIONS Increase the weight FDA assigns to contraceptive effectiveness and convenience of use. Establish a comprehensive postmarketing surveillance system to provide systematic and timely feedback about positive and negative health effects of contraceptive products. Hold an international conference of drug regulatory officials to increase the priority given to contraceptive development, to harmonize regulatory requirements of different countries to such extent possible, to discuss need for greater postmarketing surveillance of new contraceptives, and to clarify basis for regulatory decisions in individual countries. Complete review by FDA of its toxicological requirements for the evaluation of contraceptive products; especially in studies using the beagle dog. Prepare a report by an independent body three to five years hence to assess FDA requirements with respect to contraceptives.

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