"Citizens have until November 1, 2005, to submit comments."
FDA Seeks Your Input on Morning-After Pill"
by Wendy Wright, Concerned Women for America
The Food and Drug Administration (FDA) has announced it needs guidance on whether the controversial morning-after pill should be available without a prescription but with age restrictions. Since the FDA has never approved over-the-counter status for a drug based on the buyer’s age, it has asked for advice on whether the agency has the authority to do it, and if an age restriction could be enforced.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 didn’t decline.
Citizens have until November 1, 2005, to submit comments.
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.
Another point often touted as a "benefit" of Emergency Contraception is that it will not increase sexual activity among teens, especially unprotected sex. In an April 1, 2004 article, the Associated Press said in its headline: "Study: Morning-after pill won’t boost unprotected teen sex." However, AP’s reporters displayed revisionist reporting at a new "high" (or should I say, low), when its article stated that "26 teens [girls aged 15-20] who were given the pills [in advance at home] reported using them 38 times…[while] in the group that…had to go out and get them, 20 teens reported using them 24 times." Six more teens with easy access used MAPs to end possible pregnancies after unprotected sex, and, as a group, used them on fourteen more occasions of unprotected sex in six months. That sure sounds like "boosting unprotected teen sex" to me.
The study in that AP article was detailed on Medscape, reporting that "The Compton Foundation, the Open Society Institute, the Walter [sic] Alexander Gerbode Foundation, and the William and Flora Hewlett Foundation supported this study [financially]. The Women's Capital Corporation [WCC], distributor of Plan B, donated EC for use in the trial."
The Women's Capital Corporation is partly owned by the largest seller of EC, Planned Parenthood, which sold 633,756 packs of it in FY2003 and makes between 63.3% and 71% of their clinic revenue from abortions (that's from their annual report). And two of these foundations (Compton, Gerbode) financed Plan B’s development, while the other two donate millions to Planned Parenthood and other abortion advocates:
"WCC is a privately held company…to develop and market Plan B…[WCC is] a public/private sector partnership…Financing…has come, in large part, from…the David and Lucile Packard Foundation, the Wallace Alexander Gerbode Foundation, and the Compton Foundation…Five Planned Parenthood affiliates also made equity investments in Plan B…"The William and Flora Hewlett Foundation gave International Planned Parenthood Federation (IPPF) and various PP chapters a total of $5.88 million between 1997 and 2000. Open Society gave $31 million between 1998 and 2003 to abortion providers and advocates, including Planned Parenthood ($1 M), National Abortion and Reproductive Rights Action League (NARAL) ($700,000), and the Center for Reproductive Law and Policy ($1.5 M).
So this "study" reported (but didn't really find) "results" favoring increased use of the risky, health-harming, abortifacient drug MAP/EC in girls as young as 15 years old, to be sold over-the-counter like aspirin without parents' knowledge. The study was financed and sponsored by large financial backers of the largest seller of MAPs/EC, who in turn partly finances the development and distribution of MAP/EC.
Who's politicized whom?
The CWFA's FDA invitation information notice continues:
And, since the drug does not prevent or treat sexually transmitted diseases (STDs), the STD rates skyrocket.These could be the same study (one has to be a paying member to access this first website's conference journal), but a study finding this was published in The Royal Economic Society's 2004 Annual Conference Report, Swansea, 5-7 April 2004:
"[T]he shift towards greater promotion of emergency birth control appears to have worsened the impact on STI [sexually transmitted infection] rates since 2000," when the morning-after pill became available without prescription. The study concluded: "[I]t appears that some measures aimed at reducing adolescent pregnancy rates induced changes in teenage behavior that were large enough not only to negate the intended impact on pregnancy rates but to have an adverse impact on another important area of adolescent sexual health - sexually transmitted infections."The (possible) second study is discussed by SPUC Scotland (The Society for the Protection of Unborn Children):
Dr. David Paton [of the University of Nottingham’s School of Economics] also recently studied the results from policies in England implemented from 1998 to 2001 to provide sexual health services for young people and found that increases in the numbers of clinics and clinic sessions attended by young people had little impact on teenage pregnancies and did not lead to any reduction in teenage pregnancy rates. He also 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, [emphasis mine] a very logical conclusion. He concludes that although policies may be aimed at a particular outcome, consideration has to be given to the impact such policies will have on behaviour. He states "… it appears that some measures aimed at reducing adolescent pregnancy rates induced changes in teenage behaviour that were large enough not only to negate the intended impact on pregnancy rates but to have an adverse impact on … sexually transmitted infections". (32)CWFA's FDA invitation information notice continues:
(32) Paton D, "Random Behaviour or Rational Choice? Family Planning, Teenage Pregnancy and STIs." Nottingham University Business School, November 2003, p.29.
The FDA originally declined to make Plan B available to anyone without a prescription, citing concerns that Barr had not proven that adolescents can safely use it.Even the editor of the prestigious Journal of the Americal 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.
The FDA has provided a unique opportunity that will affect families throughout America.
Should the FDA ignore the above studies? Should any drug company make boodles of dollars by selling something dangerous (and proven so) to our 13-year-old girls? Will we be able to quickly roll back such a decision when pedophiles and other molesters force this over-the-counter drug on their victims? Should Planned Parenthood make $20-per-pillpack profit selling this to every girl no matter how young? What rights do parents have if this is allowed?
Here's how to take action, if you feel strongly about this:
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 20852
3. 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 email@example.com. This phone number and this e-mail account have been set up to address questions relating to this notice.