Morning After Pill Maker Will Lobby States for Plan B OTC Status

National   |   Steven Ertelt   |   Aug 30, 2005   |   9:00AM   |   WASHINGTON, DC

Morning After Pill Maker Will Lobby States for Plan B OTC Status Email this article
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by Steven Ertelt Editor
August 30, 2005

Washington, DC ( — Now that the Food and Drug Administration has indefinitely postponed a decision on whether or not to allow the morning after pills to be sold over the counter, the maker of the drug plans to take its case to state legislatures across the nation. Barr Laboratories says it will extensively lobby the forty-three states that do not allow the drugs to to be sold without a prescription.

So far seven states, including, California, Hawaii, Maine, New Hampshire, New Mexico and Washington, have allowed the drug, which can cause abortions, to be purchased over the counter without a doctor’s visit.

Without federal approval to expand into the rest of the states, Barr hopes to persuade state lawmakers elsewhere to use their state regulatory laws to join the other seven.

So far, the company has "focused our efforts at the federal level," Barr CEO Bruce Downey tells USA Today. "I think it’s fair to say we may be the initiator going forward in selected states."

FDA Commissioner Lester Crawford announced Friday that the agency would not approve the drug for sale because of various enforcement issues.

Barr wants to be able to see it directly to women over the age of 16 while requiring younger teens to still obtain a prescription from a doctor beforehand. However, Crawford said that would be difficult to implement.

"These are profound regulatory decisions that cut to the heart of our work," he explained. "The answers to these questions can establish very broad and far-reaching policies that could have a significant effect on the way FDA regulates many different drugs."

Downey said the FDA‘s action was "unexpected" and he called the difficulty of enforcing the age limit a "manageable problem."

Pro-life groups say the drugs expose teens to risky sex and add that studies show they don’t reduce pregnancy or abortion rates.

"I believe the FDA is being sensitive to the fact that this drug is not like others," Wendy Wright of Concerned Women for America said.

"How can you make it available (over-the-counter) for most women and not have it get into the bodies of girls for whom it has not been approved without prescription? This will allow more people into the process of making that assessment," she explained.

Crawford said his agency would allow for further public input and involvement in the decision-making process, but he lowered the length of time to 60 days from the usual 90 to 120 days.