Application to Take Plan B Emergency Contraception Over-the-Counter Submitted in Canada.

Health/Medical Writers, Women's Issues

WASHINGTON--(BW HealthWire)--March 8, 2002

Women's Capital Corporation (WCC) has formally submitted, with its Canadian distributor Paladin Labs, an application to the Canadian regulatory authorities to switch its morning-after pill, Plan B(R), from prescription-only to non-prescription status.

The applicants have asked for priority review that would allow for approval in less than a year.

This action would mean that Canadian women could obtain Plan B directly from their pharmacist, without a physician's prescription. Canadian pharmacists in British Columbia and Quebec, as well as U.S. pharmacists in Washington State and California can already sell Plan B without a physician's prescription through collaborative practice agreements between pharmacists and physicians.

"Plan B meets all the essential criteria expected of an over-the-counter product," said Dr. Elizabeth Raymond, MD, MPH, of Family Health International. "It's literally safer than aspirin - simple to use with relatively few, usually mild side effects."

The Canadian application includes results from a WCC Label Comprehension Study involving nearly 600 American women, as well as post-marketing safety data from Europe. WCC will complete a second study this spring that mimics actual over-the-counter distribution at research sites in six U.S. cities. The second study is required before WCC can submit an application to the FDA for over-the-counter status in the United States. That submission is planned for summer 2002.

"Approval of the application will be a major breakthrough for Canadian women," said Sharon Camp, president, WCC. "Allowing women more timely access to emergency contraception is vital since they only have 72 hours to act after unprotected sex."

The Canadian application is officially co-sponsored by WCC of Washington, DC; Plan B's Canadian distributor, Paladin Labs of Montreal; the Society of Obstetricians and Gynecologists of Canada; and the Canadian Pharmacists Association.

Every night in the United States about 10 million couples at risk of unintended pregnancy have intercourse; among these about 27,000 experience a condom break or slip, and over 700,000 are not protected against pregnancy at all.(1) Experts estimate that emergency contraceptives, like Plan B, could potentially prevent as many as half of the three million unintended pregnancies that occur every year in the United States.(2)

The FDA approved Plan B in 1999, and Health Canadian approved the product in 2000 - both under an expedited priority review. Products identical to Plan B are available from pharmacists in Great Britain, France, Israel, and several other European countries. They are sold over-the-counter in Norway and Sweden. In February 2001, nearly 70 medical and advocacy organizations petitioned the FDA to make emergency contraception available over-the-counter. The FDA responded last month that it needed more time to study the request.

Plan B is the first progestin-only pill developed specifically to prevent pregnancy after a contraceptive accident or unprotected sex. It is highly effective and produces much less nausea and vomiting than older "morning-after pills". Plan B is not the same as an abortion pill. It does not work if a woman is already pregnant. Plan B should be taken within 72 hours of unprotected sex.

WCC is unique in the pharmaceutical industry: a for-profit company financed almost entirely by foundations and nonprofit organizations. The company works directly with the public health and women's rights communities to promote new reproductive health care options critical to women.

Plan B is WCC's first commercial product to advance women's reproductive health. The company plans to develop and market a pipeline of high priority products to address important gaps in reproductive health technology, such as additional postcoital methods, women-controlled methods to prevent sexually transmitted diseases including HIV/AIDS, and drugs to treat important gynecological disorders.

For more information about Plan B: http://www.go2planb.com.

(1) Contraceptive Technology Update, 17th edition

(2) Emergency Contraception Fact Sheet, Henry J. Kaiser Family

Foundation, November 2000.