US: Morning-after pill OK for ages 15 and up (Update)

April 30, 2013 by Lauran Neergaard
This undated image made available by Teva Women's Health shows the packaging for their Plan B One-Step (levonorgestrel) tablet, one of the brands known as the "morning-after pill." The Plan B morning-after pill is moving over-the-counter, a decision announced by the Food and Drug Administration just days before a court-imposed deadline. On April 30, 2013, the FDA lowered to 15 the age at which girls and women can buy the emergency contraceptive without a prescription—and said it no longer has to be kept behind pharmacy counters. Instead, the pill can sit on drugstore shelves just like condoms, but that buyers would have to prove their age at the cash register. (AP Photo/Teva Women's Health)

The U.S. government on Tuesday lowered to 15 the age at which girls can buy the morning-after pill without a prescription and said the emergency contraception no longer has to be kept behind pharmacy counters.

The decision by the Food and Drug Administration is an attempt to find middle ground just days before a court-imposed deadline to lift all age restrictions on the drug.

Today, Plan B One-Step is sold behind pharmacy counters, and buyers must prove they're 17 or older to buy it without a prescription. Tuesday's decision lowers the age limit to 15—and will allow the pill to sit on drugstore shelves next to condoms and spermicides or other women's health products. But customers must prove their age at the cash register.

Teva Women's Health, which makes Plan B, said it would begin over-the-counter sales in a few months.

The question is whether Tuesday's action settles a larger court fight. Earlier this month, U.S. District Judge Edward Korman of New York blasted the Obama administration for imposing the age-17 limit, saying it had let election-year politics trump science and was making it hard for women of any age to obtain the emergency contraception in time. He ordered an end to all age restrictions by Monday, for Plan B and its generic versions.

The FDA said Tuesday's decision was independent of the court case and wasn't intended to address it. Technically, the FDA approved Teva's application to sell Plan B in this manner.

The Justice Department remained mum on whether it planned to appeal Korman's decision, and the White House had no immediate comment.

The women's group that sued over the age limits said Tuesday's action is not enough, and it will continue the court fight if necessary.

Lowering the age limit "may reduce delays for some young women but it does nothing to address the significant barriers that far too many women of all ages will still find if they arrive at the drugstore without identification," said Nancy Northup, president of the Center for Reproductive Rights.

The FDA said the Plan B One-Step will be packaged with a product code that prompts the cashier to verify a customer's age. Anyone who can't provide such proof as a driver's license, birth certificate or passport wouldn't be allowed to complete the purchase. In most states, driver's licenses, the most common form of identification, are issued at age 16.

Other contraceptive contraception advocates called the move promising.

Social conservatives had opposed any efforts to loosen restrictions on sale of the morning-after pill, arguing that it was important for parents and medical professionals to be involved in such decisions involving young girls.

The group Concerned Women for America charged that health officials were putting politics and so-called progress ahead of the health of children as well as women.

Half of U.S. pregnancies every year are unintended, and doctors' groups say more access to morning-after pills could cut those numbers. The pills contain higher doses of regular contraceptives, and if taken within 72 hours of unprotected sex, can cut the chances of pregnancy by up to 89 percent. But it works best if taken in the first 24 hours.

The FDA had been poised to lift all age limits and let Plan B sell over-the-counter in late 2011, when Health and Human Services Secretary Kathleen Sebelius, in an unprecedented move, overruled her own scientists. Sebelius said some girls as young as 11 are physically capable of bearing children but shouldn't be able to buy the pregnancy-preventing pill on their own.

President Barack Obama supported Sebelius' move and a spokesman said earlier this month that the president's position hadn't changed.

The Justice Department could appeal Korman's ruling and seek a stay. If granted, the appeals process would move through the courts, while Plan B is sold over the counter whenever Teva has the product repackaged to meet FDA's requirements.

Absent a stay, "we will want to go back to court as quickly as possible and ask the judge to hold them in contempt," said Janet Crepps, a senior counsel for the Center for Reproductive Rights.

The FDA said Tuesday that Teva had provided data proving that girls as young as 15 could understand how Plan B works and use it properly, without the involvement of a health care provider. Teva plans to conduct a consumer-education program, and indicated it is willing to audit whether stores are following the age requirement, the agency said.

FDA said its ruling applies only to Plan B One-Step, and not to generic versions of the pill which would remain behind pharmacy counters with the age-17 restriction.

Explore further: US court battle escalates over morning-after pill

Related Stories

US court battle escalates over morning-after pill

December 13, 2011
Women's health advocates said Tuesday they will sue the US government for allegedly violating the constitutional rights of young teens by denying them over-the-counter access to emergency contraception.

US court orders wider access for morning-after pill (Update 2)

April 5, 2013
After a decade-long battle over access to emergency contraception, a federal judge ordered US regulators Friday to make the morning-after pill available over the counter without age limits.

US denies bid to expand morning-after pill sales

December 7, 2011
US regulators on Wednesday rejected a drug company's request to make emergency contraception available over the counter to consumers of all ages instead of by prescription to those under 17.

US mulls easier access to emergency contraception

December 6, 2011
US regulators are considering whether to grant a drug company's request to make emergency contraception available over the counter to people of all ages instead of by prescription.

Block of OTC morning-after pill sparks debate

December 8, 2011
It's the morning after and the controversy over how to sell emergency contraception still looms.

Recommended for you

Study suggests ending opioid epidemic will take years

July 20, 2017
The question of how to stem the nation's opioid epidemic now has a major detailed response. A new study chaired by University of Virginia School of Law Professor Richard Bonnie provides extensive recommendations for curbing ...

Team-based model reduces prescription opioid use among patients with chronic pain by 40 percent

July 17, 2017
A new, team-based, primary care model is decreasing prescription opioid use among patients with chronic pain by 40 percent, according to a new study out of Boston Medical Center's Grayken Center for Addiction Medicine, which ...

Private clinics' peddling of unproven stem cell treatments is unsafe and unethical

July 7, 2017
Stem cell science is an area of medical research that continues to offer great promise. But as this week's paper in Science Translational Medicine highlights, a growing number of clinics around the globe, including in Australia, ...

Popular heartburn drugs linked to higher death risk

July 4, 2017
Popular heartburn drugs called proton pump inhibitors (PPIs) have been linked to a variety of health problems, including serious kidney damage, bone fractures and dementia. Now, a new study from Washington University School ...

Most reproductive-age women using opioids also use another substance

June 30, 2017
The majority of reproductive-age and pregnant women who use opioids for non-medical purposes also use at least one other substance, ranging from nicotine or alcohol to cocaine, according to a University of Pittsburgh Graduate ...

At-risk chronic pain patients taper opioids successfully with psychological tools

June 28, 2017
Psychological support and new coping skills are helping patients at high risk of developing chronic pain and long-term, high-dose opioid use taper their opioids and rebuild their lives with activities that are meaningful ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.