In the United States, Plan B has largely been replaced by Plan B One-Step and Next Choice One-Dose. These pills are approved for sale through pharmacies without prescription to women and men 17 and older. Click here for more info.
Plan B and the Bush Administration
Plan B has a sad history with the Bush Administration and the FDA:
- The FDA delayed for 2.5 years in making Plan B available without a prescription; when it did so, it kept Plan B as a prescription product for females younger than 18
- Plan B was added to the Department of Defence Basic Core Formulary on April 3, 2002, but was removed the next month
- No mention of EC, including Plan B, was made in the first National Protocol for Sexual Assault issued in September 2004 by the Department of Justice
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.