Plan B
In the United States, the emergency contraceptive pill Plan B is approved for sale through pharmacies without prescription to women and men 18 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 2, 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
- However:
- Plan B is on the World Health Organization's Essential Medicines List
- Plan B is on the United Nations High Commissioner for Refugees List of Essential Drugs
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
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