The History of Emergency Contraception

NY Federal Judge Overrules FDA Over-The-Counter Ban On Emergency Contraception Pill
History of Emergency Contraception. Justin Sullivan / Getty Images

In the United States, the history of emergency contraception has sparked controversy, ignited political debates and generated lawsuits. The heated nature of emergency contraception is due, in part, to whether or not people believe that the morning-after pill acts to prevent a pregnancy from occurring or whether it terminates a pregnancy that has already been established. Plan B One-Step (i.e., the morning-after pill) is often confused with RU486 (i.e., the abortion pill).

These two medications are not the same and each works entirely differently when it comes to the process of reproduction.

No matter what your personal beliefs are, the history of emergency contraception and its FDA-approval in the US has been quite a volatile journey. The roots of modern emergency contraception can actually be traced back to animal studies in the 1920’s, yet human use started in the 1960’s. So buckle up, this may be a bumpy ride...

Timeline: History of Emergency Contraception

  • Mid-1960’s: Emergency contraception was used as a treatment for rape victims to prevent unintended pregnancy. Doctors would prescribe a high dose of estrogen after a rape. Though this was found to be effective, there were also a lot of harsh side effects.
  • Early 1970’s: The Yuzpe regimen was introduced, which consisted of a combination hormone formula and replaced the high-dose estrogen emergency contraception methods of the 1960's.
  • Late 1970’s: Doctors began to offer the copper IUD as the only non-hormonal method of emergency contraception.

Fast Forward Two Decades...

  • February 25, 1997: With the intent to encourage manufacturers to make emergency contraceptives available, the FDA posted in the Federal Register that the Commissioner has, “concluded that certain combined oral contraceptives containing ethinyl estradiol and norgestrel or levonorgestrel are safe and effective for use as postcoital emergency contraception” and that the FDA is requesting “submission of new drug applications for this use.”

    The agency added that it agrees with a June 28, 1996 FDA Advisory Committee that unanimously concluded that the use of four hormonal regimens can be safely and effectively used as emergency contraception -- giving its approval of the “off-label” emergency contraceptive use of birth control pills containing .05 mg of ethinyl estradiol and .50 mg of norgestrel (2 pills now/2 pills in 12 hours); .03 mg of ethinyl estradiol and .30 mg of norgestrel (4 pills now/4 in 12 hours);.03 mg of ethinyl estradiol and.15 of levonorgestrel (4 pills now/4 in 12 hours); and .03 mg of ethinyl estradiol and .125 mg of levonorgestrel (4 pills now/4 in 12 hours). At that time, the FDA gave instructions on how the following pills could be used as emergency contraceptives: Ovral, Lo/Ovral, Nordette, Levlen, Triphasil, and Tri-Levlen.

    However, the FDA also noted, in the Federal Register statement, that it was denying a November 1994 citizen petition asking the agency to allow manufacturers of certain combination birth control pills to change their labeling to include instructions on how to use those pills as emergency contraceptives.
  • September 2, 1998: The Preven Emergency Contraception Kit became the first FDA-approved product specifically for emergency contraception. Modeled after the Yuzpe regimen, the Preven Emergency Contraception Kit contained a urine pregnancy test, a step-by-step "Patient Information Book” and four pills (each containing 0.25 mg of levonorgestrel and 0.05 mg of ethinyl estradiol) -- 2 to be taken immediately and 2 to be taken 12 hours later. {*Note: this kit is no longer available.}
  • July 28, 1999: The FDA approved Plan B as the first progestin-only method of emergency contraception available in the US.

  • February 14, 2001: The Center for Reproductive Rights files a Citizen Petition with the FDA on behalf of over 70 medical and public health organizations to make Plan B available over-the-counter.
  • April 21, 2003: Barr Laboratories (then manufacturer of Plan B) submits an application with the FDA to switch Plan B from prescription to nonprescription status.

  • December 2003: The application and data from more than 40 studies were reviewed by two 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 that Plan B be sold over-the-counter. The FDA's professional staff, including John Jenkins, head of the FDA's Office of New Drugs, also agreed with the recommendation.

    About 6 Months Later...

    • May 2004: The FDA issued a letter to Barr Laboratories, denying the company’s OTC sales request and citing concerns about teen health and sexual behavior. This decision was made in spite of studies that indicated 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."

    • June 15, 2004: Senators Patty Murray and Hillary Clinton request that the General Accountability Office (GAO) initiate an audit into the FDA’s May 2004 rejection of Barr Laboratories’ application to make Plan B available without a prescription.
    • July 2004: Barr Laboratories submitted a revised application conforming to the FDA's recommendation to only seek OTC status for women aged 16 and older. The FDA schedules for a decision to be made by January.
    • August 2004: An emergency contraception review article in the journal, American Family Physician explains that the “FDA has cleared 13 brands of oral contraceptives for safety and efficacy when used for emergency contraception” and added Alesse, Levlite, Levora, Trivora, Ogestrel, Low Ogestrel, and Ovrette to the original February 1997 FDA list of pills that could be used as off-label emergency contraceptives.

    The Plot Thickens in 2005...

    • January 2005: The FDA had still not made a decision on Barr Laboratories’ revised application. Pending the decision, Senators Patty Murray, and Hillary Clinton placed a hold on the nomination of Lester Crawford to serve as FDA Commissioner. The Center for Reproductive Rights also files a lawsuit against the FDA for failure to meet its January deadlines and for ignoring science and holding Plan B to a different standard than other drugs.
    • July 2005: Senators Clinton and Murray lift their hold on Crawford (who is later confirmed by the Senate) after Secretary of Health and Human Services Michael Leavitt promises them that the FDA will make a decision by September 1, 2005. 

    • August 26, 2005: Instead of announcing a decision on the revised application, the FDA indefinitely postponed its decision, wanting to allow for public input. Commissioner Crawford acknowledged that "the available scientific data are sufficient to support the safe use of Plan B as an over-the-counter product," but the FDA still failed to allow OTC access, instead choosing to postpone the decision again. Crawford stated that the agency could not reach a decision on the approvability of the application until "unresolved regulatory and policy issues" could be further reviewed. Even though the FDA’s own expert panel had approved OTC status for Plan B on a 23 to 4 vote, Crawford still chose to override his own panel and keep Plan B as a prescription drug.
    • September 1, 2005: Assistant FDA Commissioner for Women's Health, Dr. Susan Wood resigned in protest of Crawford’s decision to delay decision-making once again. Dr. Wood claimed that "the scientific staff [at the FDA] were shut out of this decision" and that Crawford’s announcement, “amounted to unwarranted interference in agency decision-making.” In a subsequent interview, Dr. Woods explained how many of her colleagues are “deeply concerned about the direction of the agency,” and in an email to FDA coworkers and staff, she justified her resignation by saying that she, “can no longer serve as staff when scientific and clinical evidence, fully evaluated and recommended for approval by the professional staff here, has been overruled."
    • September 9, 2005: Senators Murray and Clinton, now joined by 11 of their colleagues in the United States Senate, called on the United States GOA to release the findings of its investigation examining the FDA rejection of the Plan B application. In their letter to the GAO, the senators express concern that it has been more than two years, and the FDA continues to delay the Plan B decision. This concern is heightened given that over 70 major medical organizations support the OTC use of Plan B, the available scientific data support the safe use of Plan B as an OTC product, and the FDA's own scientific advisory committee voted overwhelmingly in favor of the product being available OTC. The senators write, “This turn of events leaves the strong impression that concerns about politics have overridden concerns about public health in this process.”
    • September 24, 2005: Just two months after being confirmed, Commissioner Crawford resigns.
    • October 2005: 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."
 The GAO calls the FDA's handling 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."

    Whew... 2005 was pretty rough in the history of emergency contraception. What does the year 2006 have in store for the morning-after pill?

    2006 through 2013

    • March 2006: Andrew von Eschenbach, a friend and former physician of George W. Bush, is tapped to replace Crawford and is appointed to serve as Acting Commissioner. Under his tenure, he published a fact sheet erroneously linking abortion and breast cancer. Senators Clinton and Murray block Von Eschenbach's confirmation as FDA commissioner pending a Plan B decision.

    • June 9, 2006: The FDA denies the 2001 Citizen Petition for the first time.
    • July 2006: The FDA says the new rules are not needed, and the day before his confirmation hearing, acting FDA Commissioner Andrew von Eschenbach publicly invites Barr Labs to amend and resubmit its application by changing the OTC age restriction for Plan B to 18 and older.
    • August 24, 2006: The FDA announced its approval of the sale of Plan B OTC to those age 18 and older whereas those younger than 18 would still need a prescription to obtain this method of emergency contraception.
    • November 2006: Barr began shipping nonprescription packages of Plan B to pharmacies across the US.

    Fast Forward 2 Years...

    • December 23, 2008: Teva Pharmaceutical Industries announces it acquisition of Barr. Plan B is now marketed by Duramed Pharmaceuticals, a subsidiary of Teva.

    And the Saga Heats Up Again 3 Months Later...

March 23, 2009: In Tummino v. Torti, Federal Court Judge Edward Korman 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. The plaintiffs in this case maintained that the FDA’s rejection of the 2001 Citizen Petition was "arbitrary and capricious because it was not the result of reasoned and good faith agency decision-making." Judge Korman agreed and stated that the FDA’s reasoning lacks credibility and that the agency put politics before women's health. He also asked the FDA to reconsider its denial of the Citizen Petition.
    • 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 that the company may, upon submission and approval of an appropriate application, market Plan B without a prescription to women 17 years of age and older.
 This announcement causes emergency contraception to find its way back into the spotlight.
    • June 24, 2009: The FDA approves prescription-only use of Next Choice, the generic version of Plan B.
    • July 13, 2009: The FDA announced the approval of Plan B One-Step (a single dose pill and new version of Plan B). At this time, the FDA also has officially extended OTC access, allowing 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, and production of the old Plan B stops.

    2009 seemed to be a big year in emergency contraception history. Let's move on ahead about one year later...

    • August 16, 2010: The FDA gives final approval to the new emergency contraceptive, Ella. Ella is only available by prescription and became available on pharmacy shelves around December 2010. It works completely differently than Plan B One-Step.

      Now, Get Ready for 2011 (Sparks Ignite, Once Again)...

      • February 7, 2011: Teva Pharmaceuticals filed a supplemental new drug application with the FDA asking that Plan B One-Step be sold over-the-counter, with no age restrictions (and included additional data confirming its safety for all age use).
      • December 7, 2011: The FDA decided to grant Teva Pharmaceutical’s request to lift all age restrictions and allow Plan B One-Step to be sold over-the-counter, without a prescription. However, in a move that has never been done before, Department of Health and Human Services Secretary Kathleen Sebelius overrules the FDA’s approval and orders the agency to deny Teva’s request. Sebelius cites insufficient data to support allowing Plan B One-Step to be sold over-the-counter for all girls of reproductive age. She also explained that girls as young as 11 are physically capable of having children and did not feel that Teva proved that younger girls could properly understand how to use this product without adult guidance. This decision upheld the current requirements that Plan B One-Step (as well as Next Choice) must still be sold behind pharmacy counters after the pharmacist can verify that the purchaser is 17 years old or older. December 12, 2011: The FDA denies the Citizen Petition again, prompting the case of Tummino v. Hamburg to be reopened on February 8, 2012.

      So, the year 2012 starts off with this court case where the plaintiffs file a motion for a preliminary ban that would allow OTC access for all levonorgestrel-based emergency contraceptives (both one and two pill versions) without any age or point of sale restrictions...

      • February 16, 2012: Judge Korman issues an "Order to Show Cause" wanting to know “why the FDA should not be directed to make Plan B available to those persons whom the studies submitted to the FDA demonstrate are capable of understanding when the use of Plan B is appropriate and the instructions for its use.”
      • March 9, 2012: Teva files an amended application to make Plan B One-Step available without prescription to consumers aged 15 and over and to allow it to be available in the family planning section of a pharmacy (along with condoms, the Today Sponge, spermicide, female condoms, and lubricants) rather than behind the pharmacy counter, but proof of age would still be required at checkout.
      • July 12, 2012: The FDA approves the emergency contraceptive use of Next Choice One Dose, a generic one tablet equivalent of Plan B One-Step, and grants OTC/behind pharmacy counter status for those 17 years of age or older without a prescription.

      And with this, I lead you into the year 2013, and the conclusion of the history of emergency contraception, and its long and bumpy journey to get to where it is today...

      • February 22, 2013: The FDA approves the emergency contraceptive use of My Way, a generic one tablet equivalent of Plan B One-Step, and grants OTC/behind pharmacy counter status for those 17 years of age or older without a prescription.
      • April 5, 2013: U.S. District Judge Edward R. Korman reversed the FDA’s decision of denying the Citizen Petition and orders that the agency has 30 days to allow for over-the-counter sales of levonorgestrel-based emergency contraceptives with no age restriction. He characterized Secretary Sebelius’ decisions as being "politically motivated, scientifically unjustified, and contrary to agency precedent." Judge Korman also scolded the FDA for its inexcusable delays, emphasizing that it had been over 12 years since the Citizen Petition was filed.
      • April 30, 2013: A day or two before the agency would be required to comply with the April 5, 2013, court order, the FDA "conveniently" approves Teva’s amended application, allowing the sale of Plan B One-Step on the shelf without prescription for women aged 15 and older. Strongly maintaining that it's approval of Teva's application is "independent of that litigation" and their "decision is not intended to address the judge's ruling." Coincidence that the FDA granted Teva's request at this time? Hmm?
      • May 1, 2013: Just days before the FDA would have to comply with Judge Korman's April 5 ruling, the U.S. Department of Justice appeals and asks for a stay of his order, so the FDA would not be found in contempt of court.
      • May 10, 2013: Judge Korman denies the DOJ's request for a stay, calling this action "frivolous” and just another attempt by the FDA to delay the decision-making process.
      • May 13, 2013: The Justice Department files its appeal with the 2nd U.S. Circuit Court of Appeals in Manhattan. The court extends the deadline of Judge Korman’s ruling until May 28, 2013.
      • June 5, 2013: The 3-judge appeals court denies the DOJ's motion for a stay and orders to lift all age restrictions and allow full over-the-counter status for two-pill versions of emergency contraception, but not for one-pill emergency contraception -- Judge Korman’s order on one-pill emergency contraception has been temporarily banned pending the outcome of the DOJ’s appeal.
      • June 10, 2013: The DOJ drops its appeal and agrees to comply with the unrestricted OTC sale of Plan B One-Step as long as the generics remain age-restricted and behind the counter. The FDA also asks Teva to file a supplemental application asking for no age or sales restrictions.

      Drum roll please... the moment in emergency contraception history that we have been leading up to - YES, it's FINALLY here...

      • June 20, 2013: The FDA approves Plan B One-Step for over-the-counter sales with no age restrictions. The agency also granted three years of exclusivity for Teva to retail Plan B One-Step OTC. Manufacturers for 1-pill generic equivalents can submit supplemental FDA applications for over-the-counter sales after Teva’s patent expires in April 2016.
      • February 25, 2014: In an effort to allow for the OTC status of Next Choice One Dose and My Way (generic 1-pill alternatives to Plan B One-Step), the FDA sends a letter to the manufacturers of these products stating that the Teva's proposal for exclusivity is "too restrictive" and "too broad." The agency approved these generic alternatives to be sold with no point of sale or age restrictions under the condition that the manufacturers indicate on the product label that the use of these emergency contraceptives is intended for women ages 17 and older. The inclusion of this intended use on the package upholds Teva's exclusivity deal while also allowing for these generic alternatives to be sold over-the-counter, with no prescription or age requirements.

      The history of emergency contraception includes significant victories and some defeats. In the end, the availability of this important contraceptive serves as one more tool in the prevention of unplanned pregnancies and abortions. 


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      Tummino v. Hamburg (No. 12-CV-763) Case: 13-1690 (U.S. Court of Appeals for the Second Circuit June 5 2013). Accessed 6/6/13.

      Tummino v. Hamburg, No. 12-CV-763 (ERK)(VVP) (E.D.N.Y. Apr. 4, 2013). Accessed 10/11/13.

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