- The Washington Times - Sunday, July 28, 2013

A morning-after birth control pill that set off a bruising court battle and forged an unusual alliance between President Obama and social conservatives has hit store shelves and increasingly will become available without any restrictions.

Teva Pharmaceuticals worked this month to repackage its “Plan B One-Step” pill so it could be sold to all ages without a prescription, the result of a federal court order in April that bluntly criticized the Obama administration for thwarting attempts to make the emergency contraceptive available to girls younger than 17 without a prescription.

Teva spokeswoman Denise Bradley said Friday the company has “already seen the product on sale” in store aisles.

“We believe we’ll see more widespread availability in the coming weeks and continue to work with our retail customers to help with the transition,” she said.

Labeling plans submitted to the FDA feature the words, “New! Now Available Over the Counter” in the upper-left corner of the package.

Pro-choice advocates said they’ve seen the product in metropolitan areas such as Washington and New York City, and Teva has said it plans to make the repackaged product widely available by August. In the meantime, the Center for Reproductive Rights is culling photos of the product on shelves and posting them on Facebook.

The Justice Department initially appealed the ruling that mandated the pill’s broad accessibility, and Mr. Obama reiterated long-standing concerns about the drug’s effect on young teen girls.

Social conservatives also cried foul, saying contraceptive decisions should be made between teens and their parents and that unfettered access to emergency contraception was a bad idea.

But after an adverse ruling in the appellate courts, the Justice Department decided to drop its appeal and make the drug as easy to purchase as aspirin.

In June, the Food and Drug Administration approved Teva’s request to sell Plan B One-Step without restrictions.

The Family Research Council, a conservative nonprofit that’s tracking the issue, said it remains worried.

“We are concerned that over-the-counter availability will further isolate a girl from parents and medical professionals who care most about her and can offer the wisest solutions and advice,” FRC spokeswoman Jessica Prol said. “Easy access to Plan B also leaves girls more vulnerable to exploitation. The Obama administration’s decision to allow Plan B to be sold over-the-counter — no questions asked — is the wrong move.”

Advocates for broader access to contraception, meanwhile, say more needs to be done to make the morning-after pill affordable.

The American Society for Emergency Contraception this month said its survey of 400 pharmacies found that Plan B One-Step costs, on average, nearly $48, or slightly more than the average generic price of $42.

“Even the lowest retail prices for [emergency contraception] are beyond the reach of many women,” the society said. “In order for EC to be truly accessible to all who need it, the generic products must be made available without restrictions on the shelf along with the branded products, and all prices must be lowered to a more affordable level.”

The Reproductive Health Technologies Project criticized the FDA’s decision last week to grant exclusive marketing rights to Teva for three years. As a result, other drug makers cannot sell a generic version of the pill to customers younger than 17 without a prescription until the exclusivity period ends.

“It’s just another symptom of all of the problems we’ve seen with bringing emergency contraception over-the-counter,” RHTP President and CEO Jessica Arons said.

Teva declined to comment on the FDA’s decision.

Ms. Arons and other advocates for birth-control access said a hodgepodge of rules for Plan B One-Step versus other morning-after pills could cause confusion.

“Obviously, this regime continues to perpetuate confusion and the age restriction was never supported by the scientific evidence and only enacted for political reasons,” said Andrea Costello, an attorney for the Partnership for Civil Justice Fund, which helped to litigate the Plan B case.



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