On June 12, 2013, Judge Edward Korman of the U.S. District Court for the Eastern District of New York lifted the age restriction on Plan B One-Step contraception as was necessary to fulfill his April order (pdf) to make the emergency pill widely available to women of all ages. Plan B One-Step is a drug made by Teva Pharmaceutical Industries that provides women with emergency contraception in a one-pill version, also known as the morning-after pill.
On April 5, 2013, Judge Korman had ordered the FDA to make emergency contraception available to all women without point-of-sale limitations after the FDA rejected a citizen’s petition to do so. Judge Korman considered the FDA’s rejection “arbitrary, capricious and unreasonable.” The lawsuit was brought in part by Nancy Northup, president of the Center for Reproductive Rights. Northup commended the judge’s decision as a move that will bring the drug out from behind the pharmacy counters and to the women who need it the most. On the other hand, opposing parties argue that the decision will cause a rise in price that will limit the drug’s availability to women living in poverty.
A federal judge eventually ruled in 2009 that the FDA must make Plan B available over the counter to all consumers ages seventeen and older.
Plan B was approved as a prescription drug in May of 1999. The George W. Bush Administration proved to be very restrictive in making Plan B available without a prescription. As a result, the FDA delayed in classifying Plan B as an over the counter drug for over a decade, making Plan B available without a prescription only to women above the age of eighteen. A federal judge eventually ruled in 2009 that the FDA must make Plan B available over the counter to all consumers ages seventeen and older within thirty days and advised the FDA to consider lifting all age restrictions.
Teva Pharmaceutical Industries submitted studies on females under the age of seventeen in February 2011 to the FDA, and, in December of that year, the FDA was set to approve the drug’s over-the-counter availability without an age restriction, which was initially blocked by Secretary of Health and Human Services Kathleen Sebelius. After Judge Korman ordered to FDA to allow over -the-counter sales without an age restriction in April 2013, the FDA approved the sale of Plan B One-Step on the shelf to females ages fifteen and older.
According to proponents of the order, the issue in this case is the statutory and regulatory scheme rather than the conduct of adolescents.
Laura Ingraham of Fox & Friends argued that the Obama administration’s plan to lift the restrictions on Plan B was a “good deal for pedophiles and statutory rapists.” She further stated that selling Plan B without restrictions sends the message that daughters and boyfriends can go out to a pharmacy and get a bunch of hormone pills for little girls. However, the legal issues surrounding lifting the restrictions on Plan B in the court order do not involve adolescents engaging in illegal conduct resulting in the need for Plan B.
Instead, the decision involves the interpretation of a “general statutory and regulatory scheme relating to the approval of drugs for over-the-counter sale” with the same standards as aspirin as for contraceptives. While adolescents may lack the knowledge to make reasoned decisions, the standard for drugs to be sold over-the-counter is whether the consumer can understand how to safely and effectively use that particular drug. Although adolescent behavior that would lead to the use of this drug is considered controversial, those actions are not considered in the standard used by the court.
Judge Korman determined that the age restriction of 16 and over was “unjustified and burdensome.”
Judge Korman referenced the FDA’s history of restricting access to Plan B for political reasons as support for making the drug widely accessible and as unrestricted as possible. In 2005, Judge Korman ruled in favor of expanded access to the emergency contraceptive when a suit was filed by organizations concerned with women’s health. However, the Secretary of the Department of Health and Human Services, Kathleen Sebelius, decided that the ruling did not extend to minors because of possible health risks.
Judge Korman overruled Sebelius’s decision as being unprecedented, holding that the evidence Sebelius used to support her claim of adverse health effects was insufficient. In his decision, Judge Korman stated that it was not a case about the misuse of the drug by eleven-year olds, and that the emergency contraceptives would be “among the safest drugs sold over-the counter, [and] the number of 11-year-olds using these drugs is likely to be miniscule…”
Judge Korman also determined that the age restriction of 16 and over was “unjustified and burdensome.” Subsequently, the United States Department of Justice appealed the decision, citing that Judge Korman exceeded his authority. However, the Department has since dropped the appeal.
The government’s plan “obfuscates the true effect of the FDA’s grant of marketing exclusivity to Teva,” and confers “a near-monopoly that will only result in making a one-pill emergency contraceptive more expensive and thus less accessible to many poor women.”
While Nancy Northup considers the lawsuit a historic victory to bring contraception to women of all ages, she questions whether women will actually receive the full range of available emergency contraception if the restrictions are only lifted for the Teva’s One Step brand; a brand which may be too expensive for impoverished women. In response, Northup says that the Center for Reproductive rights will continue to advocate emergency contraception as affordable birth control. The goal is that there will be greater availability to all women in the United States from the eventual lifting of restrictions on other generic, more affordable brands. Recognizing the issue, Judge Korman posited in his decision that the plan “obfuscates the true effect of the FDA’s grant of marketing exclusivity to Teva,” and confers “a near-monopoly that will only result in making a one-pill emergency contraceptive more expensive and thus less accessible to many poor women.”