Like I said below — Letter B/Let it Be.
Here’s the headline:
FDA Announces Framework for Moving Emergency Contraception Medication to Over-the-Counter Status
And here’s the statement:
FDA announced today 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 option. The Agency and the Sponsor will discuss the Sponsor’s proposed restricted distribution and risk management plan as part of the framework for potential approvability as a non-prescription product for women ages 18 and older. FDA and the Sponsor have agreed to meet immediately to discuss the approvability of the Sponsor’s amended application and the framework by which this medicine can be made available over-the-counter. The Agency hopes that as both sides are committed to working diligently through these issues, the process can be wrapped up in a matter of weeks.
This decision is the result of a thoughtful and comprehensive scientific and public policy process undertaken by the Agency to resolve the novel and significant issues presented by the Sponsor’s amended application. Foremost in the Agency’s concerns is to establish a framework that strikes a balance between providing access to medicines considered safe and effective and ensuring the right policies are in place to promote their safe use. The Acting Commissioner, Dr. Andrew von Eschenbach, believes resolving this public health issue is an important step in moving the Agency’s broad and critical agenda forward.
Any questions?
