Emergency Contraception (EC) in the U.S.
Part 2: 2011-APR until now: Making
Plan B One-Step available to younger teens
This topic is a continuation from Part 1
2013-APR-30: FDA activity:
The FDA approved the Plan B One-Step EC for purchase without a prescription to women and to girls 15 years-of-age and older. This is a single-dose pill that is most effective if taken within three days (72 hours) after unprotected sexual intercourse. It will not stop a pregnancy that has started. There is no evidence that they will harm a developing embryo if the pregnancy has started. They will be labeled:
"Not for sale to those under 15 years of age. Proof of age required. Not for sale where age cannot be verified."
The pill will have a product code which alerts the pharmacy cashier to verify the age of the customer. To prevent shoplifting, the pill carton will include a security tag.
The FDA stated in their news release:
"Research has shown that access to emergency contraceptive products has the potential to further decrease the rate of unintended pregnancies in the United States.
The data reviewed by the agency demonstrated that women 15 years of age and older were able to understand how Plan B One-Step works, how to use it properly, and that it does not prevent the transmission of a sexually transmitted disease. These data also established that Plan B One-Step could be used properly within this age group without the intervention of a healthcare provider." 1
The FDA also referred to the federal District Court ruling in early April, saying that their ruling is:
"... independent of that litigation and this decision is not intended to address the judge's ruling.
The Department of Justice is considering next steps in the litigation. In the meantime, the FDA took independent action to approve the pending application on Plan B One-Step for use without a prescription by women 15 years of age or older." 1
2013-JUN-10: Federal Department of Justice withdrew appeal:
During the week of JUN-02, the appeals court issued a temporary ruling that permitted unrestricted sales of the two-pill version of EC pending their final ruling. This move appears to have triggered the Department of Justice to withdraw its appeal of Judge Edward Korman's earlier ruling in April. Plan B One-Step EC will thus become available over the counter without prescription to persons of all ages. A major factor in his ruling appears to be the simplicity of this particular product. Earlier types of EC medication involve two pills. The woman identifies and takes the first pill, waits a defined number of hours, and then takes the second pill. As the name implies, the One-Step product involves only one pill. The woman needs to know only how to open the package and swallow the single pill.
Huffington Post reported that:
"... the Food and Drug Administration has told the maker of the pills to submit a new drug application with proposed labeling that would permit it to be sold 'without a prescription and without age or point-of-sale prescriptions.' The FDA said that once it receives the application it 'intends to approve it promptly'." 7
White House press secretary Jay Carney said:
"We have been through a legal process and the court has ruled against the administration ... It was the decision, given the court ruling, to proceed with making the simpler version of Plan B available," 6
Annie Tummino, coordinator of the National Women's Liberation, issued a statement saying that women and girls should have:
"... the absolute right to control our bodies without having to ask a doctor or a pharmacist for permission. It's about time that the administration stopped opposing women having access to safe and effective birth control." 7
Cecile Richards of Planned Parenthood referred to the Obama Administrations decision to allow free access to Plan B One-Step as:
"... a huge breakthrough for access to birth control and a historic moment for women's health and equity." 5
Nancy Northup, president of the Center for Reproductive Rights said in a press release:
"Now that the appeals court has forced the federal government’s hand, the FDA is finally taking a significant step forward by making Plan B One-Step available over the counter for women of all ages.
But the Obama Administration continues to unjustifiably deny the same wide availability for generic, more affordable brands of emergency contraception.
We are pleased that women should soon be able to buy Plan B One-Step without the arbitrary restrictions that kept it locked behind the pharmacy counter when they needed it most urgently. But we will continue to fight for fair treatment for women who want and need more affordable options." 8
Plan B One-Step EC is currently a more expensive form of EC than the more complex two-pill EC.
Anna Higgins is the director of the Center for Human Dignity at Family Research Council (FRC). The FRC is a fundamentalist Christian group that the Southern Poverty Law Center (SPLC) has said qualifies as a hate group because of their frequent misrepresentation of topics related to homosexual orientation. 2 [The SPLC is the main national organization that monitors hate organizations in the U.S.]
Higgins' article contains some confusing statements:
She identifies the emergency contraception and discusses the label that its carton is required to show:
"The drug at the center of this controversy is levonorgestrel, commonly known as 'Plan B,' which, according to the FDA-approved label, may work by preventing ovulation or fertilization or by inhibiting implantation."
This is a true statement about the current content of the label. However, it is important to recall that the FDA required the manufacturer of "Plan B to include this label years ago when researchers could only speculate about the method(s) by which Plan B operated. Initially, it was believed that the pill could delay ovulation, and could prevent fertilization of the ovum if ovulation had already taken place, and that it might possibly inhibit implantation in the wall of the uterus. Further research has shown that Plan B only works with the first two mechanisms. All evidence confirms that Plan B and Plan B One-Step does not inhibit implantation. The manufacturer has been trying for years to obtain permission from the FDA to delete the label, without success. In the meantime, many conservative Christian information sources state incorrectly that EC does inhibit implantation. Since most religious conservatives define pregnancy as beginning with implantation, EC therefore meets their definition of an abortifacient.
She may be confusing the Plan B with the Plan B One-Step versions of EC. "Plan B" was the original form of EC sold by Women's Capital Corp. It required that two pills be taken in the correct order, separated by a specific time interval. Some have argued that it may well be beyond the ability of very young girls to handle these pills properly, particularly if they have had unprotected sex and are very frightened that they may become pregnant. When Health and Human Services Secretary Kathleen Sebelius vetoed the recommendations of the FDS panel and Commissioner, she based her objection on her doubts that very young post-pubertal girls could follow the instructions. But this concern can hardly apply to the "one step" version. It is a single pill. Any post-pubertal girl should be capable of opening the box, releasing the pill, and swallowing it.
Ms. Higgins wrote:
The administration's decision to drop its appeal of the judge's mandate demonstrates that it's willing to put aside common-sense safety concerns in the face of political pressure.
However, the statements by FDA panel and the two main national associations of physicians working in this field during 2012-NOV base their recommendations on Plan B One-Step EC being both safe and beneficial.
"Allowing Plan B to be sold over the counter to girls of all ages represents a foolhardy concession to a modern conception of sexual autonomy that jeopardizes their well-being in numerous ways. Congress needs to review Food and Drug Administration policy on over-the-counter drug approval and introduce legislation to protect parental rights on this matter." 3
CitizenLink, which is an affiliate of the fundamentalist Christian group Focus on the Family commented on the Department of Justice's decision to conform to Judge Korman's decision. They also seem to have confused Plan B with Plan B One-Step ECs. Bethany Monk writes for CitizenLink:
"The Justice Department (DOJ) decided Monday to comply with a judge’s ruling that allows anyone to buy a drug that may cause early abortions. The ruling says no one needs a prescription and minors do not require parental notification or consent to purchase the drug.
The drug, marketed as Plan B and also referred to as the 'morning after pill,' contains high levels of hormones, which have not been tested on pre-teens and teenage girls. The Obama administration previously argued that age limits were 'common sense' for those wanting to buy Plan B without prescriptions. Plan B activist groups claim, however, that unrestricted access to the drug is a form of 'reproductive justice.' ..."
Catherine Glenn Foster, Litigation Counsel for Alliance Defending Freedom, a conservative Christian legal defense agency, said:
"President Obama has yet again sided with Planned Parenthood, his favorite political ally and the single largest distributor of Plan B drugs — drugs that can destroy a life. Whatever guides this administration in its decisions, it is apparently not the health and well-being of our daughters and granddaughters. The administration’s decision is nothing short of shameful."
Janice Shaw Crouse, director and senior fellow of Concerned Women for America’s Beverly LaHaye Institute, said:
"It is irresponsible to advocate over-the-counter use of these high-potency drugs, which would make them available to anyone — including those predators who exploit young girls. Mark my words, it will not be long before we see girls and women forced to purchase Plan B for their abuser to keep them and others enslaved. This is a pimp, predator and pedophile’s dream — unlimited access to Plan B."
The following information sources were used to prepare and update the above
essay. The hyperlinks are not necessarily still active today.
Megan Brooks, "FDA Approves 'Morning-After Pill' for Girls 15 And Older," Medscape, 2013-APR-30, at: http://www.medscape.com/
David Demirbilek, "Southern Poverty Law Center repeats 'hate group' claim about Family Research Council," Daily Caller, 2012-SEP-13, at: http://dailycaller.com/
Anna Higgins, "Surrendering to politics on the morning-after pill," Family Research Council, 2013-JUN-12, Washington Times, at: http://www.frc.org/
JoNel Aleccia, "Judge OKs fed's Plan B One-Step offer, cautions against exclusivity deals," NBC News, 2012-JUN-12, at: http://vitals.nbcnews.com/
Alex Wagner, "Obama administration ends resistance to Plan B availability," MSN, 2013-JUN-11, at: http://video.msnbc.msn.com/
Ben Wolfgang & Tom Howell Jr., "Obama administration drops its appeal of Plan B ruling, will widen access to drug," Washington Times, 2013-JUN-11, at: http://www.washingtontimes.com/
Tom Hays, "Obama Plan B Decision: Feds To Comply With NY Judge's Ruling," Huffington Post, 2013-JUN-10, at: http://www.huffingtonpost.com/
"Obama Administration Announces Plans to Make Plan B One-Step Available Without Age Restriction," Center for Reproductive Rights, 2013-JUN-10, at: http://reproductiverights.org/
Copyright © 1999 to 2013, by Ontario Consultants on
Originally published on 1999-JAN-13
Latest update: 2013-JUN-13
Author: B.A. Robinson