Still some questions after White House's Plan B shift

The FDA says it will approve only the one-pill Plan B One-Step for sale off the shelf.
The FDA says it will approve only the one-pill Plan B One-Step for sale off the shelf. (Getty Images)
Posted: June 13, 2013

Don't rush to the drugstore quite yet if you are a female under 17, need emergency contraception, and have no prescription.

"I don't expect to see it at neighborhood pharmacies instantly," said Susannah Baruch of the Reproductive Health Technologies Project, which has been part of the decadelong legal fight to make such approved medicine available to females of any age, without a prescription, at the lowest possible cost.

While Baruch said Tuesday it was "fantastic" that the Obama administration indicated Monday night it would tentatively comply with parts of federal Judge Edward B. Korman's recent orders regarding access, Baruch and colleagues did not like important details in a Justice Department letter that spelled out the government's plan.

There are one- and two-pill versions of emergency contraception, often called morning-after pills. Plan B One-Step is a single-pill product at the heart of this controversy. The product is made by the drugmaker Teva Pharmaceutical Industries Ltd.

The government says in the letter it will approve only the Plan B One-Step for sale off the shelf. That opens access of a morning-after pill to anyone, of any age.

The two-pill versions will still require girls under 17 to provide a prescription and proof-of-age at a pharmacy counter. Pharmacies often close before other areas of stores that sell health-care products, thus limiting access to the two-pill contraceptives.

Many of the two-pill versions are also cheaper because they are generics, so higher costs could limit their use by some.

Also in doubt is how long generic companies will have to wait to sell one-pill versions without a prescription.

"This is not a minor issue," Baruch said, noting that Plan B One-Step might cost $50 and generics $10 to $20 less, potentially another restriction to access for some.

Teva is based in Israel but has its Americas headquarters in North Wales, Montgomery County. Teva spokeswoman Denise Bradley declined comment.

Oral emergency contraceptives containing levonorgestrel are meant to reduce the chances of pregnancy for a female who has sexual intercourse without other birth control. But the pills must be taken within three to five days of intercourse, depending on the particular pill.

Today, girls under 17 need a prescription for any of the three kinds of morning-after pills now available. One requires a prescription for any age.

On April 30, Teva received approval to sell Plan B One-Step over the counter to 15- and 16-year-olds, with proof of age. The company also got three years of exclusivity from the FDA, but products are not yet on shelves. FDA spokeswoman Erica Jefferson declined to comment on whether Teva would get exclusivity when it reapplies for sale to all ages.

The International Consortium on Emergency Contraception estimates that 60 countries have such drugs available over the counter. But in 2011, Health and Human Services Secretary Kathleen Sebelius overruled the FDA - with support from President Obama - and said the pills should not be available to younger teenagers without a prescription.

Like other parents, Baruch - who has daughters aged 10 and 12 - said she was "terrified" by the idea of teenage girls having sex too soon, with too little information and too little protection.

"We would all like to think they will talk to us," Baruch said of parental guidance. "But public policy can't be based on wishful thinking. Teenage pregnancy is an enormous public health issue."


Contact David Sell at 215-854-4506, dsell@phillynews.com, or @phillypharma. Read his blog at www.inquirer.com/phillypharma.

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