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Barr Pharmaceuticals will mount an education campaign aimed at raising awareness of emergency contraception among healthcare professionals, now that Plan B has been granted OTC status.
“The education campaign will clearly communicate the prescription age requirement and the appropriate use of emergency contraception,” Barr spokeswoman Carol Cox told MM&M.
Barr will also provide continuing education and distribute educational materials through its 250-person women’s healthcare sales force, which also details Barr’s Seasonique extended-cycle oral contraceptive and Enuvia hormone therapy.
Further information about the education campaign was not disclosed.
Meanwhile, Barr will continue to target its Plan B consumer advertising efforts at women's magazines such as Glamour, Jane, Cosmopolitan and Marie Claire, in the “age appropriate group over 18 years of age,” as well as pursue targeted web advertising, Cox said.
Pace, a unit of Interpublic Group based in Parsippany, NJ, handles both professional and consumer advertising for Plan B and will take on any additional duties called for by the over-the-counter (OTC) switch, agency CEO Mary Cobb said.
The FDA on Thursday approved Plan B as an OTC option for women age 18 and older.
The drug will remain available as a prescription-only product for women under 18.
Last week’s approval ends years of contentious debate over the OTC status of the drug.
An application for the OTC approval of Plan B was first submitted three years ago. An FDA advisory committee in December 2003 voted overwhelmingly to approve it for all ages but the application was rejected six months later by the agency due to concerns the pill would be available to young teens.
Last year, after the senate confirmed former FDA Commissioner Lester Crawford, Health and Human Services secretary Michael Leavitt said the agency would act on the Plan B application by September 2005.
But before issuing a ruling, the FDA decided to hold off on a decision indefinitely and continue to seek comments from the public on the matter.
For reasons that still remain unclear, Crawford resigned his post as commissioner after only two months on the job.
Last month, the FDA announced a framework to resolve policy issues associated with Plan B as an over-the-counter option, just prior to acting agency commissioner Andrew von Eschenbach’s scheduled testimony at a Senate hearing on his nomination to become permanent agency chief.
The Senate confirmation committee did not vote on von Eschenbach’s nomination as Sens. Hillary Clinton, D-NY and Patty Murray, D-Wash., said they would place a hold on the nomination until the FDA reached a final decision on Plan B.
The senators lifted the ban this week but von Eschenbach still faces a major roadblock before his nomination is given the green light.
CNN.com reported that Sen. David Vitter's, R-LA, would maintain his hold on von Eschenbach's nomination to pressure the FDA to approve the import of prescription drugs from Canada.
It is a long-standing Senate tradition that a senator may place a hold on, or block, a nomination for federal office for almost any reason, the report said.
When senators return to Washington in September, however, the GOP leadership may pressure Vitter to release the hold and allow the full Senate to vote on the long-delayed nomination.