Questions about effect of over-the-counter Plan B for all ages

June 29, 2013

When it comes to the morning-after pill, one thing is clear: Girls of any age who have unprotected sex or a birth-control mishap will soon be able to walk into a local pharmacy or big-box store and get emergency contraception without a doctor’s prescription.

But many questions remain. For example, the placement and cost of the product — Plan B One-Step — might vary, depending on the store and other factors. And larger societal questions about the repercussions of easier access to emergency contraception, including its effect on behavior or unplanned pregnancies, won’t be settled for years.

Before the Food and Drug Administration approved Plan B One-Step without restrictions this month, ending a decade-long battle, girls 16 and younger needed a prescription to obtain the pill. Girls 17 and older had to present proof of age to a pharmacist for the product, which was kept behind the counter.

Now, Plan B One-Step, which is made by Teva Pharmaceutical Industries, will be on shelves in many stores, perhaps as early as August. CVS, for example, said the pill would be displayed in the family-planning aisle, in special security packaging. But some independent pharmacists have said they will keep the medicine behind the counter.

David Toth, owner of Tschiffely Pharmacy in Dupont Circle, said he intends to keep Plan B, which he sells for $42.50, behind the counter, along with other expensive items, to prevent shoplifting. “Anything over $20 is not going to be out front,” Toth said.

And despite the FDA’s decision to drop age restrictions, “if someone can’t see over the counter” — as in, looks too young — he will refuse to sell it, he said.

Toth’s plans complicate the easy access pushed by advocates of emergency contraception and others, who say some girls might be too inhibited to ask for a product kept behind the counter.

“Some people are too scared to buy condoms, so people might be too scared to buy Plan B as well,” said Isabella Albamonte, 17, a student at the District’s Woodrow Wilson High School.

Another potential barrier is the price. Teva said the cost to retail and wholesale outlets will remain unchanged, but it remains to be seen whether retailers alter what they charge consumers.

In general, Plan B has been selling for about $40 to $50, which could be out of reach for younger girls. But there is a way to get it free: Under the 2010 health-care law, insurance plans covered by the statute are required to provide all ­FDA-approved contraceptives at no cost — but only if the purchaser presents a prescription. Consumers buying it off the shelf will have to pay full price.

There may be another way to lower the cost without a prescription. Women’s health advocates have urged that generic versions be made available on store shelves without age restrictions, along with Plan B. Among those products is Actavis’s Next Choice One Dose, which sells for about $10 less than the Teva product.

But if the FDA grants Teva market exclusivity, which runs for three years, generics will remain age- and point-of-sale-restricted. Often the FDA will reward innovation — such as developing a new drug — by granting a manufacturer limited protection from competition. Teva is hopeful that it will receive such exclusivity from the FDA, but FDA says it has not made a decision.

Women can also pick up the pill at Planned Parenthood, whose more than 750 health centers carry some form of emergency contraception, and more will probably carry Plan B One Step now that it is approved, a representative said.

While the nuts-and-bolts consumer issues are worked out, a larger, long-term debate is swirling. Those who supported getting rid of the restrictions on the morning-after pill say increased availability can reduce the number of unintended pregnancies. Opponents argue that easier access to the one-dose pill will encourage girls to have unprotected sex, and they express concern about side effects.

Neither side’s arguments hold much weight, says James Trussell, a Princeton University economist and an authority on emergency contraception.

On the question of safety, Trussell said: “It’s definitely safer than aspirin, far safer. Nobody ever died from taking Plan B.”

Although used to prevent pregnancy, Plan B does no harm to the fetus if a woman becomes pregnant despite taking it, studies have shown. There are side effects similar to those caused by regular birth-control pills, such as changes in menstrual cycle, nausea, fatigue and cramping.

To be effective, Plan B should be taken within 72 hours after unprotected sex; the sooner it is taken, the better it works. This was cited as one reason for having the drug on the shelf and readily accessible. Also, research has shown that readily available emergency contraceptives do not increase sexual recklessness.

At the same time, contrary to the view of many Plan B supporters, it won’t solve the unintended pregnancy problem, Trussell said.

He said the relatively few women and girls who would even think of using emergency contraception are like a “cork on the great sea of unprotected sex out there.” Over-the-counter Plan B will not have a public-health impact, he said, citing “many, many studies” that do not show lowered pregnancy or abortion rates.

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