Judge rejects limits on morning-after pill
President Barack Obama once fretted about the prospect that girls as young as 10 or 11 could walk into a drugstore and buy emergency contraception pills as easily as “bubble gum or batteries.”
With his blessing, the Department of Health and Human Services set aside the advice of medical experts and blocked efforts to allow girls younger than 17 to get the so-called morning-after pill without a prescription.
That age limit is poised to disappear now that a federal judge has cleared the way Friday for girls – and boys – of any age to purchase the medication without having to notify their parents or a doctor.
In a sharply worded ruling that called government regulators “politically motivated and scientifically unjustified,” U.S. District Judge Edward Korman ruled that levonorgestrel- based contraceptives such as Plan B One-Step and Next Choice One Dose should be available over the counter to all customers within 30 days.
“There is no serious health risk associated with use of Plan B as prescribed and intended, much less one that would make restrictions on distribution necessary for its safe use,” Korman wrote.
Unless successfully appealed by the U.S. Department of Justice, the ruling would make contraceptives as readily available to minors as Tylenol or Benadryl. The biggest barrier to access would be the pill’s hefty $50 price tag.
Reproductive rights advocates hailed Korman’s ruling as a victory of science over politics, and said the ruling was a long time in coming for the politically sensitive drug.
“A federal judge has accomplished what two administrations failed to do: make a decision about access to a drug based on medical evidence,” said Michael Halpern, program manager at the Center for Science and Democracy at the Union of Concerned Scientists.
The lawsuit that prompted the order was brought by the Center for Reproductive Rights. On Friday, the center’s president, Nancy Northup, released a statement calling the decision a blow to deep-seated discrimination.
“Women all over the country will no longer face arbitrary delays and barriers just to get emergency contraception,” she said.
Although the ruling noted that both the George W. Bush and Obama administrations had a hand in restricting access, Korman’s action placed reproductive rights groups in the odd position of siding with a Republican- appointed federal judge who had harshly critical words for a Democratic administration.
“This case is not about the potential misuse of Plan B by 11-year-olds,” the judge wrote. “These emergency contraceptives would be among the safest drugs sold over-the-counter,” he noted, and “the number of 11-year-olds using these drugs is likely to be minuscule.”
Justice Department spokeswoman Allison Price said the government was “reviewing the appellate options and expects to act promptly.”
Plan B was the first emergency contraceptive drug approved in the United States and required a prescription when it came on the market in 1999.
The drug, a synthetic hormone, prevents pregnancy by blocking ovulation and impeding the mobility of sperm. It does not cause an abortion in women who are already pregnant; nor does it harm a developing fetus.
In 2006, the Food and Drug Administration allowed adults to buy the drug over the counter but still required prescriptions for those younger than 18.
In late 2011, the FDA was ready to permit the nonprescription sale of the drug to people of all ages, but Health and Human Services Secretary Kathleen Sebelius overruled the agency and continued to require prescriptions for those 16 and younger. She cited concern that the drug had not been tested in girls as young as 11, even though 10 percent of them are “physically capable of bearing children.”
It was the first time that a Health and Human Services secretary had overruled an FDA decision.
To critics, it seemed that presidential politics was the real reason for Sebelius’ action. The 2012 election was less than a year away.
The Center for Reproductive Rights went to court and argued that the age and prescription requirements limited access to the drug for all women by creating confusion among pharmacists and clerks. Also, because pharmacists kept the drug behind the counter, it was not available outside regular 9-to-5 pharmacy hours.
The pills are most effective when taken immediately after intercourse, and preferably within 24 hours, although they are sometimes effective even after 72 hours.
Teva Pharmaceutical Industries, which makes Plan B One-Step, said that when the drug is taken as recommended it is effective in seven of eight cases.
Nearly half of all pregnancies that occur in the U.S. each year are unintended, according to Planned Parenthood. Roughly 750,000 pregnancies will occur among 15- to 19-year-olds each year.
Much of the controversy surrounding Plan B centered on the uncomfortable prospect that girls barely into their teens were having sex.
Critics argued that easy access to the drug would encourage sexual activity and promote the spread of sexually transmitted infections.
“There is a real danger that Plan B may be given to young girls, under coercion or without their consent,” said Anna Higgins, director of the Center for Human Dignity at the Family Research Council. “The involvement of parents and medical professionals act as a safeguard for these young girls. However, today’s ruling removes these common- sense protections.”
Doctors’ groups emphasized that the drug was necessary to reduce unplanned pregnancies, especially among teens. Children born to teenage mothers are more likely to have health problems, drop out of high school, be incarcerated or become teen moms themselves, according to the Centers for Disease Control and Prevention. The net effect of all that on taxpayers is about $11 billion a year, according to the National Campaign to Prevent Teen and Unplanned Pregnancy.
“The focus is on trying to prevent unintended pregnancies,” said Dr. Diana Ramos of the American Congress of Obstetricians and Gynecologists.