Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

GYNOPHARMA TO LAUNCH NORCEPT E 1/35 "NEXT MONTH"

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.

You may also be interested in...



Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth

UsernamePublicRestriction

Register

OM013164

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel