[personal profile] moominmuppet
Not a done deal yet, but fabulous news nonetheless! (I'm frustrated that news reports are still using the old "72-hour" guideline instead of the newer 120 hour guideline, though)

The title on the first article is a bit misleading, in my opinion. This means they're recommending it for OTC approval, not that it's set in stone. It has to be approved by the FDA commissioner, first.

Feminist Daily News Wire
December 16, 2003


***BREAKING NEWS*** FDA Panel Approves Emergency Contraception Over-the-Counter

In a resounding win for reproductive and women's rights advocates, the Food and Drug Administration's Reproductive Health Drugs Advisory and Nonprescription Drugs Panels voted 23-4 to recommend over-the-counter status for Plan B, a brand of emergency contraception.

Testifying on behalf of the Feminist Majority Foundation, Dr. Beth Jordan told the FDA panels that "the scientific evidence and public health imperative propelling this request for EC is strong and undeniable. Access delayed is access denied. For the sake of women whose lives and futures are at stake, please make this decision on scientific merit, not politics."

Using the drug within three days of unprotected sex can significantly reduce the chance of getting pregnant, and the sooner the drug is taken, the more effective it is. In addition, advocates for over-the-counter accessibility of EC argue that it is often difficult to find a doctor to write a prescription in time, especially on holidays and weekends.

Over-the-counter access to emergency contraception could prevent more than a million unplanned pregnancies and hundreds of thousands of abortions every year. The Feminist Majority Foundation leads a national drive on college campuses to increase the availability of EC. At today's hearing, FMF presented more than 30,000 student signatures gathered in support of EC and the results of a survey that highlights the lack of availability and inaccessibility of EC on our nation's campuses.

Original article with embedded links


Contraception & Family Planning | FDA Advisory Panels To Meet Jointly, Make Recommendation on Selling EC Without Prescription
[Dec 16, 2003]
The FDA advisory committees on nonprescription drugs and reproductive health drugs on Tuesday will meet jointly to decide whether to recommend that the emergency contraceptive Plan B be sold without a prescription, the Boston Globe reports (Dembner, Boston Globe, 12/16). In April, Washington, D.C.-based Women's Capital Corporation, which originally brought Plan B to the market in 1999, applied to the FDA to sell the drug without a prescription. In October, Pomona, N.Y.-based generic drug maker Barr Laboratories acquired the drug from WCC. EC, which can significantly reduce the risk of pregnancy if taken within 72 hours of unprotected sexual intercourse, is thought to work by interrupting ovulation, preventing fertilization of an egg or inhibiting a fertilized egg from implanting in the uterus (Kaiser Daily Reproductive Health Report, 12/15).

FDA Briefing
In a briefing posted Monday on the FDA Web site, FDA staffers supported the move, saying that there is little potential for misuse and that women would benefit from expanded access to the drug, the Globe reports (Boston Globe, 12/16). "Because emergency contraception is more effective in preventing pregnancy the earlier it is taken after unprotected sexual intercourse, over-the-counter status should enhance [the drug's] benefit by providing more timely access to the product than through prescription," according to the briefing. The panels will hear presentations from FDA staff, Barr Laboratories and the public before making a recommendation (Richwine, Reuters, 12/15). Although decisions on drugs usually follow advisory panel recommendations, the agency is not required to do so; the FDA commissioner will make the final decision, which may take months to reach (Boston Globe, 12/16). If the FDA supports making EC available without prescription, the agency would then have to decide whether the drug would be available on store shelves or be requested from a pharmacist, an option that would allow women to receive advice about the drug (Neergaard, AP/St. Louis Post-Dispatch, 12/16).

Arguments
Dozens of medical and public health groups, including the American Medical Association and the American Public Health Association, support offering EC without a prescription. The Alan Guttmacher Institute in 2002 released a report saying that widespread EC availability could prevent 1.7 million unintended pregnancies and cut the number of abortions by 800,000 each year (Wetzstein, Washington Times, 12/16). In addition, a group of more than 70 health and advocacy groups have signed a petition supporting nonprescription EC. However, several groups, including Concerned Women for America, oppose the move, saying that broader access to the drug could increase sexual activity and the incidence of sexually transmitted diseases (AP/St. Louis Post-Dispatch, 12/16). The U.S. Conference of Catholic Bishops, which "adamantly oppose[s]" the move, said that the United Kingdom and New Zealand have issued warnings that EC can increase the risk of developing an ectopic pregnancy, a potentially fatal condition in which an embryo implants in the fallopian tube instead of the uterus, according to the Globe. However, FDA staff said that the problem occurs in about 2% of pregnancies in the United States and in about 1.5% of cases in which women used Plan B, meaning that women who used Plan B were not at a greater risk of the condition. An FDA medical officer who reviewed safety data on the drug said that it had "an acceptable margin of safety with a low misuse and abuse potential" (Boston Globe, 12/16). However, the FDA staffers in the briefing did recommend warning labels telling women not to take Plan B if allergic to the hormone contained in the drug and asking women to see a doctor if severe stomach pain is experienced, a possible sign of ectopic pregnancy (Reuters, 12/15).

NPR's "Morning Edition" Tuesday reported on the debate. The segment includes comments from Dr. Paul Blumenthal, associate professor of obstetrics and gynecology at Johns Hopkins University Medical School; Planned Parenthood Federation of America President Gloria Feldt and Concerned Women for America Policy Director Dr. Wendy Wright (Neighmond, "Morning Edition," NPR, 12/16). The complete segment is available online in RealPlayer.

NPR's "Talk of the Nation" on Tuesday is scheduled to discuss the FDA panels' debate and the science of contraception (Conan, "Talk of the Nation," NPR, 12/16). The complete segment will be available online in RealPlayer after 6 p.m. ET.

Several resources on EC are available online from the Kaiser Family Foundation. The resources include a fact sheet on EC methods, safety and side effects and access issues; a survey that includes information on prescribing practices and counseling for EC and views on increasing access to EC; and listing of states with policies on EC dispensation, including states that allow direct pharmacy access without a prescription and states with emergency room dispensation mandates for sexual assault survivors.

Date: 2003-12-17 11:41 am (UTC)
From: [identity profile] heron61.livejournal.com
I saw that and was very pleased. I think the fact that an election is coming up may help keep the forces of evil from pushing to hard to stop this too.

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