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The Emergency Contraception Website - Your website for the "Morning After"

Plan B

 

In the U.S., Plan B One-Step is available without age restrictions to women and men (check the family planning aisle). One-pill generics (My Way and Next Choice One Dose) will soon be available on the shelf for consumers aged 17 and older, but this change has not taken effect yet; women aged 16 and younger still need a prescription. Two-pill generics (Levonorgestrel Tablets) are still available only behind the counter without prescription if you are 17 or older; younger women need a prescription.

History of Plan B OTC:

  • May 1999: Plan B approved as Rx drug by the FDA
  • April 2003: Application submitted to switch Plan B from Rx to OTC; FDA decision due February 2004
  • December 2003: FDA convenes advisory committee, which votes 23-4 in favor of taking Plan B OTC
  • February 2004: FDA announces that it will delay decision on Plan B up to 90 days
  • May 2004: FDA rejects application to switch Plan B from Rx to OTC, citing lack on data on females younger than 16
  • June 2004: Congress requests report on FDA decision not to switch Plan B from Rx to OTC (report released in October 2005). Report concludes that decision on Plan B was "highly unusual", and may well have been made months before it was formally announced
  • July 2004: Barr Laboratories submits amended application to make Plan B Rx for females older than 16 and OTC otherwise
  • January 2005: Deadline for FDA to respond to Barr's application
  • July 2005: HHS Secretary Leavitt promises that FDA will act on Barr's application by September 1, 2005, to ensure a vote on Senate confirmation of Lester Crawford as FDA Commissioner
  • August 2005: FDA announces that Plan B is safe for OTC use by women 17 and older, but announces an indefinite delay, citing three concerns (and allowing a 60-day public comment period on the first two questions):
    • Can Plan B be both Rx and OTC depending on age?
    • Can Rx and OTC versions of Pan B be marketed in the same package?
    • Can an age restriction for Plan B be enforced?
  • July 2006: The day before his confirmation hearing, acting FDA Commissioner Andrew von Eschenbach publicly invites Barr Labs to resubmit its application by changing the OTC age restriction for Plan B to 18 and older
  • August 18, 2006: Barr labs resubmits its application to make Plan B available OTC to consumers 18 and older, and Rx to women aged 17 and younger
  • August 24, 2006: FDA approves making Plan B available OTC to consumers 18 and older and Rx to women aged 17 and younger
  • November 2006: Barr Labs begins shipping Plan B in new packaging to pharmacies
  • March 23, 2009: Federal judge rules that the FDA must make Plan B available OTC to consumers 17 and older within 30 days and urges the agency to consider removing all age restrictions. Read the full text of the decision here
  • April 22, 2009: The FDA announces that Plan B may be sold OTC to women and men aged 17 and older
  • February 7, 2011: Teva submits actual-use study data and label-comprehension study data on females <18 to the FDA

  • December 7, 2011: the FDA is set to approve OTC status for Plan B with no age restriction based on the studies submitted by Teva. However, this action was overruled by the Secretary of Health and Human Services Kathleen Sebelius

  • 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 rather than behind the pharmacy counter; proof of age would still be required at checkout.

  • April 5, 2013: U.S. District Judge Edward R. Korman orders the FDA to allow over-the-counter sales of LNg ECPs with no age restriction. Read the decision here.

  • April 30, 2013: the FDA approves Teva’s amended application, allowing sale of Plan B One-Step on the shelf without prescription for women aged 15 and older. Read the FDA press release here.

  • May 1, 2013: U.S. Department of Justice appeals Judge Korman's April 5 ruling, seeks a stay of this order to remove age and point-of-sale requirements.
  • May 10, 2013: Judge Korman denies DOJ's request for a stay, reprimands Administration.
  • June 5, 2013: A 3-judge appeals court denies the DOJ's motion for a stay, demands that 2-pill generic ECPs be made available without restrictions.
  • June 10, 2013: DOJ drops its appeal, agrees to support unrestricted approval of Plan B One-Step if generics remain age-restricted and behind the counter.
  • June 20, 2013: FDA approves Plan B One-Step for unrestricted sale on the shelf.

 

 

 

 

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