U.S. drops age limits for Plan B One-Step

EXECUTIVE SUMMARY

The United States is dropping its appeal against a court order to lift age restrictions on emergency contraceptive pills (ECPs) so the best-known ECP, Plan B One-Step, may be sold over the counter to women of all ages.

• The Food and Drug Administration (FDA) has since approved Plan B One-Step’s new label, which allows it to be sold without restrictions.

• Manufacturers of generic versions of the ECP are asked to submit amendments to their FDA abbreviated new drug applications to be considered for over-the-counter sales. If marketing exclusivity is given to Plan B One-Step, however, such access for generics might be limited.

The United States is dropping its appeal against a court order to lift age restrictions on emergency contraceptive pills (ECPs) so the best-known ECP, Plan B One-Step, may be sold over the counter to women of all ages.

The Obama administration said June 10 it would comply with U.S. District Edward Korman’s April 2012 ruling to make Plan B One-Step available over the counter without age or point-of-sale restrictions. (Did you receive the Contraceptive Technology Update bulletins issued on June 6 and June 11 on the latest legal moves with emergency contraception? To receive breaking news as it occurs, provide your e-mail address to AHC Media customer service at (800) 688-2421 or customerservice@ahcmedia.com.)

The Food and Drug Administration (FDA) on June 20 approved the new label for Plan B One-Step, which allows it to be sold over the counter without age restrictions.

According to a June 10 letter submitted by the Department of Justice to District Judge Edward Korman, the department says it expects the sponsors of the generic versions of Plan B One-Step to submit appropriate amendments to their abbreviated new drug applications to the FDA. If FDA grants Teva marketing exclusivity, though, the scope of that exclusivity might affect the labeling that could be approved for generic equivalents of the drug, the letter notes. Plan B One-Step generated $82.6 million in sales in 2012, followed by generic version Next Choice (Actavis, Parsippany, NJ) with $56.3 million, according to data compiled by IMS Health, a Danbury, CT, healthcare technology and information company.

Additionally, the FDA will not take steps to change the approval status of the two-pill Plan B or its generic equivalents, states the Department of Justice letter. This move is a reversal of actions following the June 6 appeals court ruling that would have allowed all-age access to two-pill ECP versions. Stock of such product might be limited, however, due to the increased popularity of the one-dose version of the drug.

The FDA is finally taking a "significant step forward by making Plan B One-Step available over the counter for women of all ages, noted Nancy Northup, president and chief executive officer of the New York City-based Center for Reproductive Rights in a June 10 press statement. However, the Obama Administration continues to unjustifiably deny the same wide availability for generic, more affordable brands of emergency contraception, Northup says. The center will continue to advocate for fair treatment who want and need more affordable options than the branded single-dose ECP, she says.

Advocates hail halt to restrictions

Reproductive health advocates are cheering the removal of age restrictions for Plan B One-Step.

"We finally see light at the end of the tunnel in our decade-long fight to give all women access to a safe, reliable, back-up contraceptive option, said Susannah Baruch, interim president and chief executive officer of the Washington, DC-based Reproductive Health Technologies Project. "We will continue to hold the administration accountable in ensuring that all emergency contraception products, including generics, are available over the counter without age restrictions.

Cecile Richardson, president of New York City-based Planned Parenthood Federation of America, issued a press statement on behalf of the organization to encourage manufacturers of emergency contraception to quickly request new labeling, as well as for the FDA to issue immediate approvals, to make all levonorgestrel ECPs available to all women.

Will adolescents, as well as young women, be able to safely use Plan B One-Step now that it will be available over the counter? Data indicates that young and adult women find the label and instructions for levonorgestrel ECPs easy to understand.1,2 Research also shows that teens and young women who received multiple ECP supplies at one time did not use the pills repeatedly in place of routine contraceptive methods.3

The levonorgestrel-only regimen is simple to follow, and medical supervision is not necessary for correct use.4

According to the New York City-based International Consortium for Emergency Contraception, which tracks EC availability around the globe, six countries offer direct access to emergency contraception: Bangladesh, Canada, India, Netherlands, Norway, and Sweden. A total of 65 countries allow access to EC from a pharmacist without a prescription.

It is important for all women of all ages to have access to emergency contraceptive pills, but women who need them once might need them many more times in a year, states Robert Hatcher, MD, MPH, professor emeritus of gynecology and obstetrics at Emory University School of Medicine in Atlanta. Because of their cost, very few women use ECPs every time they have totally unprotected sex or make mistakes using combined pills as their regular contraceptive, says Hatcher.

"The global effect of ECPs is close to zero, asserts Hatcher. "The emphasis should shift immediately to the emergency insertion of Copper T 380A [ParaGard] intrauterine devices.

REFERENCES

1. Cremer M, Holland E, Adams B, et al. Adolescent comprehension of emergency contraception in New York City. Obstet Gynecol 2009; 113:840-844.

2. Raymond EG, L’Engle KL, Tolley EE, et al. Comprehension of a prototype emergency contraception package label by female adolescents. Contraception 2009; 79:199-205.

3. Harper CC, Cheong M, Rocca CH, et al. The effect of increased access to emergency contraception among young adolescents. Obstet Gynecol 2005; 106:481-491.

4. Bixby Center for Global Reproductive Health. Should teens be denied equal access to emergency contraception? Accessed at http://bit.ly/11UqcJH.