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Executive Summary

GYNOPHARMA TO LAUNCH NORCEPT E 1/35 "NEXT MONTH" with patient informed consent forms, company founder and Chairman Broderick MacKenzie said at the Third Annual Women Taking Charge Conference April 17. "Next month we are launching an oral contraceptive," he said, which "will have with it an informed choice brochure . . . In fact all of our drugs will have that type of information available to women." GynoPharma says it will be the first company to include informed consent literature with an oral contraceptive product. Last spring, the company launched its ParaGard copper IUD, which also included a patient information and informed consent package insert. The Norcept packaging will be "copied on the same model as the IUD model," MacKenzie noted. For the IUD, the company requires doctors to furnish the patient with an information booklet, and asks that women wishing to use the device sign the informed consent form. The Norcept labeling will strongly urge, but not require, physicians to have the patient read and sign the information insert. MacKenzie credited Alza for initially developing the innovative patient information and consent approach for its Progestasert IUD. "We looked at what Alza did and what the Planned Parenthood group of clinics did and we also created an . . . informed consent program for our interuterine device," MacKenzie said. Alza Group Product Manager for Progestasert Carol Christopher explained that in developing the program, "Alza felt that we could provide the communication between the physician and patient, and provide the patient the information she needed to make an appropriate decision." Christopher explained that the benefits of the informed consent program include "better informed patients, a greater mutual trust between patients and physicians, and I think from a manufacturer's perspective, between patents and physicians and manufacturers." Misuse of the product, she maintained, will be less likely. When the patient "understands a product more completely, she has more realistic expectations of both the risks and the benefits of the product," resulting in "better compliance and also less use by inappropriate patients," Christopher said. In response to industry concerns that product liability risks are a disincentive for companies to work on contraceptive research and development, Consumers Union Legislative Counsel Linda Lipsen pointed out that "drug cases and cases involving medical devices are about the hardest cases to win in our product liability system." She noted that the current standard of liability "is strict liability" which "the courts have actually stretched out to . . . really mean negligence. We're not talking about a litigation 'free for all.'" However, American Home Products General Counsel Charles Hagan said he considers product liability risks to be "a very, very substantial factor" in limiting the development of new contraceptives today. However, he mentioned that Wyeth-Ayerst has two new contraceptive products near the end of the pipeline -- Norplant and gestodene, a low dose progestational drug. The NDA for long-acting Norplant, submitted by the Population Council, was reviewed by FDA's Fertility and Maternal Health Drugs Advisory Committee April 27 (see related story, p. 8). The NDA for gestodene, Hagan noted, was filed last year.

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