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Byline: Judith Graham
Aug. 1--After almost a year's delay, the Food and Drug Administration said Monday that it would reconsider a highly controversial proposal to make the "morning-after" pill available over the counter. The agency said it would resume talks with the drug's manufacturer, Barr Pharmaceuticals Inc., in the next week and hoped to agree on an approval process "in a matter of weeks" if the talks went well. "The acting commissioner, Dr. Andrew von Eschenbach, believes resolving this public health issue is an important step," the FDA said. But the pills won't be available without prescriptions in drugstores anytime soon.
The government has asked Barr to file a revised application and meet unusually strict standards, including enforcing a provision that limits drugstore sales to women age 18 and up. Many experts question whether the company will be able to comply with the agency's demands.
"I hope the agency is sincere and genuinely plans to expand access to this medication," said Dr. Georges Benjamin, executive director of the American Public Health Association. "If…
Source: HighBeam Research, 'Morning-after' pill reconsidered: FDA says it will take new look at...