FDA Gives Final Approval for Morning After Pill Sold Over the Counter

National   |   Steven Ertelt   |   Aug 24, 2006   |   9:00AM   |   WASHINGTON, DC

FDA Gives Final Approval for Morning After Pill Sold Over the Counter Email this article
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by Steven Ertelt
LifeNews.com Editor
August 24, 2006

Washington, DC (LifeNews.com) — The Food and Drug Administration has given the final approval for the morning after pill to be sold over the counter to women over the age of 18. The decision means teenagers must still visit a physician for a prescription for the drug, which some pro-life groups oppose because may cause an abortion in some instances.

The decision ends a three year battle between FDA officials and abortion advocates, who roundly criticized the agency for taking so long to make a final decision.

Barr Pharmaceuticals, the maker of the Plan B drug, said it hopes to begin nonprescription sales of the drug in pharmacies by the end of the year. The drug company plans to conduct an extensive marketing campaign to promote sales of the morning after pill.

The pills will not be on shelves but sold from behind the pharmacy counter in order for pharmacists to check a photo identification and ensure the buyer is over 18 years-old.

Dr. Andrew von Eschenbach, the FDA’s acting commissioner, said in a memo that the agency did not approve the drug for sales to teenagers because Barr had not provided enough information about how the morning after pill affects them.

He indicated that Barr provided sufficient data to show the morning after pill is safe for older teenagers and adults and he indicated pharmacies are used to checking to make sure a buyer is over 18 with tobacco and some other products.

Barr agreed to track how well pharmacists are enforcing the 18 and up rule as a condition of approving the drug for sales and it will do that, AP reported, by sending anonymous shoppers to buy it along with other methods. The company must track sales twice a year in the first year and annually thereafter.

Pharmacies that break the rules must be reported to state officials.

"This approach should help ensure safe and effective use of the product," von Eschenbach concluded, according to an AP report.

Bruce Downey, Barr’s chairman, said he was pleased with the decision but wished the FDA had approved the drug for sales to all women, including younger teens.

Barr initially applied to sell the drug over the counter three years ago and the FDA asked it to submit a new application and said Barr did not provide enough information about how the drug affected teens.

The FDA asked Barr to submit a revised proposal to sell the drugs over the counter only to women above the age of 16 but, when it did so, the FDA stalled on approving the application. Agency officials said they were reviewing enforcement issues related to selling the drug to older women.

Nine states, including Washington, California, New Mexico, Alaska, Hawaii, Maine, New Hampshire, Massachusetts and Vermont had already passed regulations allow sales of the morning after pill over the counter before the FDA acted. They will still be the only states allowing women of any age — including younger teens — to buy the Plan B drug.