EC Over-the-Counter (OTC) Status

FDA Approves Plan B for OTC Sales for Consumers 17+; Women Under 17 Still Need Prescription

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On April 22, 2009, the FDA announced that it would allow 17-year olds to purchase Plan B OTC. The announcement followed a U.S. District Court decision in March 2009 finding that the FDA had bowed to political pressure from the Bush Administration in its 2006 decision to limit EC access with age restrictions.

Teva Pharmaceuticals, Inc. issued a new EC product: Plan B® One-Step. Plan B® One-Step replaces the previous Plan B product that came as two pills, now with the same medication in one pill. This product is available OTC for consumers 17 and older and with a prescription for women younger than 17. Watson Pharmaceuticals, Inc. has also released a generic version of EC – Plan B Next Choice™ – which is available by prescription-only to women ages 17 and younger.

Compare different ways to access EC
Comprehensive list of approved Plan B contraceptive products
EC Pharmacy Access in an OTC Environment
Brief History of the Plan B OTC Application
EC Pharmacy Access in an OTC Environment

The FDA decision to make Plan B an OTC product for consumers 17+ will not change the current availability of EC through a pharmacist-initiated prescription in the nine states that allow it. Currently, Washington, California, Alaska, New Mexico, Hawaii, Maine, New Hampshire, Massachusetts and Vermont allow pharmacists to directly dispense emergency contraception to a woman without her having to first get a prescription from a provider. The pharmacy access model is now more critical than ever for younger women, undocumented women or women without proof of age to obtain fast, convenient access to EC.

Brief History of the Plan B OTC Application

Many medical groups support OTC access to EC, such as the American Medical Association and the American College of Obstetricians and Gynecologists who have formal resolutions stating EC is so safe it should be OTC.

The application for making EC OTC was first submitted in April 2003, by Women’s Capital Corporation, the initial marketer of Plan B. Containing strong safety, actual use, and label comprehension data, the application was officially filed June 20, 2003. In February 2004, Barr Laboratories acquired Plan B and continued to support the OTC application.

Although the FDA Reproductive Health Drugs and Non-Prescription Drugs Advisory Committees overwhelmingly recommended switching EC to OTC, the FDA delayed its decision from the initial February 20, 2004 deadline to May 21, 2004, requesting more time to review data on adolescent use.

On May 6, 2004, the US Food and Drug Administration (FDA) rejected an application to switch Plan B (a dedicated EC product) to OTC status. The FDA offered Barr Laboratories two alternatives for future submissions: 1) to provide additional data on use by adolescents and 2) to outline and support marketing plans for dual access: nonprescription for women 16 and older, and prescription for women younger than 16.

On July 22, 2004, Barr Laboratories submitted information to support marketing for dual access to Plan B: non-prescription for women 16 years and older and prescription-only for women under 16. On January 21, 2005, the FDA informed Barr that it was unable to complete its review of the application. On August 26, 2005, then acting FDA Commissioner Crawford indefinitely delayed action on Barr’s revised application, stating a need for public input on legal issues surrounding regulation of a dual-label status drug. Within days, Susan Wood, FDA Assistant Commissioner for women’s health resigned in protest of the agency’s failure to approve OTC sales of Plan B. The next month, Crawford resigned from the FDA.

On July 31, 2006, in a letter to Barr one day ahead of his Senate confirmation hearing, acting FDA Commissioner von Eschenbach said he was willing to consider nonprescription sales for those 18 and older as long as the drug is kept behind the pharmacy counter, On August 24, 2006, the FDA approved sales of Plan B from behind pharmacy counters to consumers ages 18 and older without a prescription. Women 17 and younger are still required to have a prescription for Plan B.

By June 2007, eight states (HI, IL, MA, NJ, NJ, OK, OR, WA) confirm Medicaid coverage for Plan B OTC. Medicaid continues to cover Plan B obtained via prescription. (In July 2009, NM is added to this list.). In a hearing with the House Committee on Oversight and Government Reform on July 10 2007, Former Surgeon General Richard Carmona said the Bush administration routinely blocked him from speaking about or issuing reports on certain issues – including emergency contraception and other sensitive public health topics.

On March 23, 2009, the U.S. District Court for the Eastern District of New York ruled that the FDA allowed politics to interfere with its usual decision-making process in reviewing Plan B. In siding with the Center for Reproductive Rights, it ordered the FDA to allow nonprescription sales of Plan B to 17-year-olds and reconsider its previous decision. Within a month, on April 22, 2009 the FDA announced that 17-year olds could also purchase Plan B OTC.

On June 24th, 2009, the FDA approved Watson Pharmaceutical, Inc.’s generic version of Plan B Next Choice™ EC. This generic drug was approved for prescription-only use in women ages 17 and younger.

On July 13, 2009, Teva Pharmaceutical, Inc. announced that the FDA approved Plan B® One-Step EC – containing the same medication as the former two-dose Plan B, with just one tablet. This product is available OTC to consumers age 17 or older; women younger than age 17 require a prescription.

EC is currently available behind the counter in the UK, Australia, and New Zealand. On April 20, 2005, the Canadian Health Minister announced Plan B availability behind-the-counter in Canada. The amendment was published in the Canada Gazette on May 4, 2005. For coverage on opposition, history, reports from the committee hearing, letters of support, and press coverage, as well as specific information about EC pharmacy access activity in other states, Canada, and Australia, please visit