FDA Clears Path For Teens to Buy Cheaper 'Morning After' Pill

Monday, 03 Mar 2014 02:09 PM

By Sandy Fitzgerald

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Teen girls, no matter their age or health status, are now able to purchase cheaper, generic versions of Plan B One-Step and other popular emergency contraceptive pills over the counter and without their parents' permission.

The Food and Drug Administration has lifted a ban on generic versions of the pills, NPR reported, adding access to less expensive versions of the controversial drug.

The FDA last July, following a court order, removed age restrictions on sales of Plan B One-Step, which prevents most pregnancies in women weighing less than 165 pounds if it is taken within 72 hours of unprotected sex.

But at that time, while approving the drug to be sold without a prescription, the FDA had allowed the Plan B maker, Teva Pharmaceuticals, to be protected from competing with generic drugmakers in exchange for conducting a market study on teen use of the emergency contraceptives.

Teva had also contended the generic version of the drug should not be sold over the counter to people of any age, but in an 11-page letter to generic competitors last week, Kathleen Uhl, acting director of the FDA's Office of Generic Drugs, said that Teva's claim in age restrictions was too broad.

Women's groups had campaigned hard to make the product more accessible, since the generic version is at least $10 less expensive than the name brand. Plan B One-Step costs about $50, and the generic versions, Next Choice One Dose and My Way, range from $20 to $35.

However, One Step's label says the product is recommended for girls 15 and older, while the generic versions say they should be used by people 17 and older. But no matter what the label, teenagers will still be able to buy the drug directly without showing proof of age.

"This is a significant leap forward in obtaining full, over-the-counter status for emergency contraception, and we commend the FDA for this decision," said Jessica Arons, president and CEO of the Reproductive Health Technologies Project. "Everyone deserves a second chance to get it right."

Erica Jefferson, FDA acting assistant commissioner for media affairs, told The Boston Globe that once companies submit their revised labeling, "the agency will work to approve it as soon as possible."

Older emergency contraceptives, which require that a person take two pills 12 hours apart, will remain behind the pharmacy counter, where it does not require a prescription but can only be sold to people age 17 and older and with a valid form of identification.

"This week’s decision means lower cost emergency contraception will be available to women of all ages," Martha Walz, president of the Planned Parenthood League of Massachusetts told The Globe. "As a result, more women will gain access to emergency contraception, and this should reduce the number of unintended pregnancies."

But Walz said she's puzzled over the labeling issue.

"I don’t know why the FDA would have any differences in labels for a generic," since it’s an identical product to the brand name, she said. "Young teenagers reading these labels might be compelled to spend double the amount without realizing that both products are equally safe and effective."

Not all health professionals are convinced the drug is safe for teenagers.

Donna J. Harrison, executive director of the American Association of Pro-Life Obstetricians and Gynecologists, wrote in an op-ed in The New York Times about CVS' decision to stop selling tobacco products that the chain will still be selling a dangerous drug without the need of a prescription by selling emergency contraceptives over the counter to teenagers.

"The unfettered availability of emergency contraception raises serious concerns, not least because access to Plan B does not reduce the number of unintended pregnancies or abortions," Harrison wrote.

"Aside from being ineffective, over-the-counter access to emergency contraceptives is harmful to women’s health," she continued. "It isolates the most at-risk women, teenagers, and those in unstable relationships from getting the medical care they need to diagnose sexually transmitted diseases and access appropriate contraceptive counseling ... This is not a product to be sold over the counter with no more consultation than buying M&Ms."

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