Plan B’s Troubled History:
- Emergency contraception originated in the 1960s as treatment for rape victims to prevent unintended pregnancy. Doctors would prescribe a high dose of birth control pills after a rape.
- July 28, 1999: The FDA approved Plan B as the first progestin-only EC available in the US
- April 2003: Barr Laboratories (then manufacturer of Plan B) submits an application to switch Plan B from prescription to nonprescription status.
- December 2003: The application and data from more than 40 studies and was reviewed by 2 FDA advisory committees, the Reproductive Health Drugs committee and the Nonprescription Drugs committee, who all unanimously agreed that Plan B was safe and effective. The FDA panel votes 23-4 to recommend Plan B be sold OTC. The FDA's professional staff, including John Jenkins, head of the FDA's Office of New Drugs, also agreed with the recommendation.
- May 2004: The FDA issued a "not approvable" letter to Barr Laboratories, citing concerns about teen's health and sexual behavior, in spite of studies indicating that Plan B use did not increase promiscuity or alter women's use of other birth control methods.
This move by the FDA to ignore scientific data and expert opinions drew fire from the scientific community. The American College of Obstetricians and Gynecologists called the decision "morally repugnant" and "a dark stain on the reputation of an evidence-based agency like the FDA."
- July 2004: Barr Laboratories submitted a revised application conforming to the FDA's recommendation to seek OTC status only for women aged 16 and older.
- January 2005: The FDA had still not made a decision on the application. Pending the decision, Sens. Patty Murray and Hillary Clinton placed a hold on the nomination of Lester Crawford to serve as FDA Commissioner.
- July 2005: Clinton and Murray lift their hold on Crawford (who is later confirmed by the Senate) after a promise by Secretary of Health and Human Services Michael Leavitt that the FDA will make a decision by Sept. 1.
- September 2005: Instead of announcing a decision, the FDA indefinitely postponed its decision. Officials acknowledged that "the available scientific data are sufficient to support the safe use of Plan B as an over the counter product," but they still failed to allow OTC access, instead choosing to postpone the decision again.
- Commissioner Crawford passed the Plan B action, which said that "until unresolved regulatory and policy issues" could be reviewed, Plan B would not be available OTC and would remain a prescription drug.
The Plot Thickens:
- Then Assistant FDA Commissioner for Women's Health, Dr. Susan Wood resigned in protest, saying that "the scientific staff [at the FDA] were shut out of this decision." A month later, Dr. Frank Davidoff, a former member of the Nonprescription Drugs Advisory Committee, also resigned in protest. The New England Journal of Medicine issued its second editorial, charging the FDA with making "a mockery of the process of evaluating scientific evidence."
- Following the FDA announcement and Wood's resignation, several U.S. senators issued in a statement that "this turn of events leaves the strong impression that concerns about politics have overridden concerns about public health in this process." They also called on the Government Accounting Office (GAO), which had opened an inquiry into the FDA’s Plan B decision-making process, to release the results of their investigation to the public.
- A month after the announcement of its postponed decision, Crawford resigned.
- October 2005: The GAO calls the FDA's handing of Plan B "highly unusual," prompting Sen. Clinton to comment that the report "appears to confirm what we have suspected for some time: Science was compromised in the FDA's decision-making process on Plan B."
- March 2006: Tapped to replace Crawford and serve as Acting Commissioner was Andrew von Eschenbach, a friend and former physician of George W. Bush. Under his tenure, he published a fact sheet erroneously linking abortion and breast cancer. Clinton and Murray block Von Eschenbach's confirmation as FDA commissioner pending a Plan B decision.
- July 2006: The FDA says the new rules are not needed and invites Barr to amend its application to seek OTC sales to women 18 and older.
- August 24, 2006: The FDA announced its approval of the sale of Plan B OTC to those age 18 and older.
- November 2006: Barr began shipping nonprescription packages of Plan B to pharmacies across the US.
- December 23, 2008: Teva Pharmaceutical Industries announced it acquisition of Barr. Plan B is now marketed by Duramed Pharmaceuticals, a subsidiary of Teva.
- March 2009: A federal court ordered the FDA to allow 17-year-olds to buy Plan B OTC under the same conditions that it was already available to women 18 and older.
- April 22, 2009: Due to federal court order instructing the FDA to allow 17-year-olds to purchase Plan B, the FDA confuses everybody by announcing that 17-year-olds can buy Plan B OTC. But, all this announcement really consisted of was the FDA declaring that it has "notified the manufacturer of Plan B informing the company that it may, upon submission and approval of an appropriate application, market Plan B without a prescription to women 17 years of age and older."
- June 24, 2009: The FDA approves prescription use of the generic version of Plan B, Next Choice.
- July 13, 2009: Plan B One-Step gains FDA approval. Access is increased as the FDA allows women and men age 17 or older to purchase Plan B One-Step at the pharmacy counter without a prescription upon verification of age (those under 17 need a prescription).
- August 28, 2009: The FDA approves the OTC sale of Next Choice, the generic form of Plan B, to all those age 17 or older (girls 16 and younger need a prescription to obtain Next Choice).
- September 2009: Plan B One-Step becomes available at retail pharmacies nationwide.
- December 7, 2001: Secretary of HHS, Kathleen Sebelius, vetoes the FDA’s decision to approve full over-the-counter access (no age requirement) of Plan B One-Step and instructs the FDA to deny Teva's request for OTC status.
- July 13, 2012: The FDA approves the emergency contraceptive use of Next Choice One Dose as the generic equivalent of Plan B One-Step.
Where It StandsThough the concept of emergency contraception is not a new idea to society, it is still igniting many debates just as it did when it was first introduced to the United States. The controversy stems from people's beliefs about whether or not Plan B (or the morning-after pill) terminates a pregnancy.
Emergency contraception continues to be a highly emotional and controversial issue, both for advocates who believe Plan B will lower the number of unintended pregnancies and abortions, and for opponents who believe that using Plan B amounts to an abortion. The controversy fueling this debate centers on the ways that emergency contraception works. This debate is so heated that it even managed to cloud the FDA’s decisions about Plan B, leaving this agency to be accused of allowing politics to dictate their decisions rather than science.
Unfortunately, the misguided belief that emergency contraception causes abortion has created a barrier to the access and use of Plan B as many people continue to confuse Plan B with the abortion pill, RU486. Whereas the abortion pill results in a termination of a pregnancy and is only used after pregnancy is established (and no more than 49 days since a woman’s last menstrual period), Plan B One-Step is used to prevent pregnancy when taken within 3 to 5 days after unprotected sex. It will not harm an existing pregnancy.
In fact, medical experts consider a pregnancy to be established only once the implantation of a fertilized egg has occurred. Advocates of emergency contraception remain firm about informing people that Plan B One-Step is not an agent of abortion. Medical authorities define an abortion as the disruption of an implanted fertilized egg. This means that it is impossible for Plan B One-Step to terminate a pregnancy since, medically, a pregnancy doesn’t exist. Federal policy, in accordance with medical experts, defines medication, drugs and devices that act before implantation as preventions to pregnancy and not agents that terminate pregnancy.
Plan B One-Step is a safe and effective method for women to PREVENT a possible pregnancy after engaging in unprotected sexual intercourse and has proven to be a significantly influential option that has helped drastically reduce the number or unwanted pregnancies as well as the number of abortions that would have taken place if these pregnancies were not prevented through the use of emergency contraception.