US federal regulators are seeking public comment on whether the "morning-after" pill should be made available without prescription.
The Food and Drug Administration (FDA) is weighing a request to make the "Plan B" pill available over the counter only to women above a certain age threshold. The FDA has declined to make the pill available to all customers regardless of age, citing concerns that adolescent girls may not know how to use the pill safely.
Citizens have until November 1, 2005, to submit comments.
Afterabortion has been covering the issues here and here:
(...) Barr Labs, which bought Plan B from Women's Capital Corporation [remember this name...], has argued that making Plan B easily available would reduce pregnancies and abortions. They have run into a problem, though, in that studies show just the opposite. Where the drug is available without a prescription, pregnancies and abortions do not go down. In fact, several studies show that the number of abortions increase.Vital Signs Blog adds a quote from Susan Wood:(...) In Finland and Scotland, studies showed that abortion rates stayed the same despite increased "over-the-counter" Morning After Pill (MAP or "Emergency contraception") use (by girls aged 15 or more) of 25% in one year and 300% over eight years, respectively. And even worse, in Finland, 23% more girls under 15 had abortions that year. The Scottish Council on Human Bio-ethics' "Briefing Paper on the Morning-After-Pill," Jan. 2002, found that, despite a 300% increase in the use of MAPs in Glasgow from 1992-1999, the abortion rate didnt decline.
(...) Dr. David Paton [of the University of Nottinghams School of Economics] found that there was a significantly higher rate of diagnoses of STIs and that this was in particular worsened by the shift in policy towards greater provision of the morning-after pill
(...) Even the editor of the prestigious Journal of the American Medical Association and one of the FDA's own senior safety scientists recently publicly stated their grievous concerns about the FDA and its drug safety process.
Meanwhile, these same activist groups fail to mention the real facts about Plan B. They continue to state that the morning after pill is just contraception, that it doesn't cause an abortion even though they say that Plan B works by "inhibiting implantation."Also, see Susan Wills guest commentary on the National Review Online:Eggs don't implant. Sperm don't implant. But embryos do. The linguistic loophole they've created suggests that pregnancy doesn't begin until the embryo has implanted. Basic biology, on the other hand, confirms that a unique living human organism exists from the moment of conception. Abortion means ending a pregnancy with the specific intention of destroying an unborn life, no matter how young it may be.
Only if you redefine pregnancy as beginning when the six- to seven-day-old human embryo begins implanting in the uterine lining. But medical textbooks uniformly agree that pregnancy is "the gestational process, comprising the growth and development within a woman of a new individual from conception ... to birth" (Mosby's Medical, Nursing & Allied Health Dictionary, 2002). In fact, a hormone called early pregnancy factor, which is produced by the developing embryo, can be measured in the mother's blood at three days before implantation. Pretending pregnancy begins at implantation is simply a ploy to avoid admitting the abortifacient properties of hormonal "contraception."AfterAbortion suggests that those concerned about Plan B do the following:How does EC work? If taken pre-ovulation, EC may delay or inhibit ovulation, thereby preventing conception; but often it does not. If taken after the LH surge which triggers ovulation, EC will not disrupt ovulation in that cycle, but can inhibit implantation of the developing embryo (causing his death) due to changes in the uterine lining. (See, e.g., C. Kahlenborn, MD et al., "Postfertilization Effect of Hormonal Emergency Contraception," The Annals of Pharmacology, March 2002.)
1. All submissions must include the agency name (Food and Drug Administration) and either the Docket Number 2005N-0345 or Regulatory Information Number (RIN) 0910-AF72.Submit written comments in the following ways:
1. Fax: 301-827-6870.
2. Mail/hand delivery/courier (for paper, disk, or CD-ROM submissions):
Division of Dockets Management
5630 Fishers Lane, Rm. 1061
Rockville, Maryland 208523. E-mail: The FDA is no longer accepting comments submitted to the agency by random e-mails. However, electronic comments can be submitted using the Federal eRulemaking Portal http://www.regulations.gov or the agency Web site http://www.fda.gov/comments.html . (Keyword: 2005N-0345)
All comments received will be posted without change to http://www.fda.gov/ohrms/dockets/default.htm, including any personal information provided.
Docket: For access to the docket to read background documents or comments received, go to http://www.fda.gov/ohrms/dockets/default.htm. Insert the docket number into the "Search" box and follow the prompts, and/or go to:
Division of Dockets Management
5630 Fishers Lane, Rm. 1061
Rockville MD 20852.For further information, contact the FDA at 301-827-0002 or by e-mail at pcomments@fda.gov. This phone number and this e-mail account have been set up to address questions relating to this notice.
