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news.The FDA has announced that it is proceeding to work with Duramed, a subsidiary of Barr Pharmaceuticals, to resolve the remaining policy issues associated with the marketing of Plan B as an over-the-counter drug.
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The agency and Duramed will discuss the company’s proposed restricted distribution and risk management plan as part of the framework for potential approvability of the emergency contraceptive as a non-prescription product for women ages 18 and older.
The FDA said it will meet with Duramed immediately, and hopes that the process can be wrapped up in a matter of weeks.
While this appears to be good news for Duramed, it has provoked pro-life groups, which disagree with the notion of making the drug available without a prescription. Indeed, Deirdre McQuade, pro-life spokeswoman for the US Conference of Catholic Bishops, expressed her disapproval in a statement in which she claimed “over-the-counter availability would allow these drugs to be used routinely, despite the fact that they are not approved for such use.”