WOODCLIFF LAKE, NJ: Barr Laboratories said the FDA's decision to delay granting over-the-counter (OTC) status to Plan B, an emergency contraceptive, would not significantly change any marketing activities planned for the drug.
"We believe Plan B meets the criteria" necessary for being sold OTC, said Carol Cox, VP of investor relations and corporate communications for Barr. "Our job is to work with the FDA to provide the additional information they requested." In the meantime, Cox said, Plan B would remain available by prescription.
Last October, Barr signed a letter of intent to acquire Plan B from Women's Capital Corporation (WCC). Under WCC's ownership, Plan B had unimpressive sales, which is thought to be due largely to the company's limited marketing budget. Cox said the acquisition is expected to be completed in "the next few weeks."
On February 13, the FDA extended the original 10-month deadline for completion of its review of Plan B, part of a drug category more commonly referred to as morning-after pills. The extension grants the agency a maximum of 90 days to continue reviewing Barr's application to sell Plan B without a prescription.
The decision to delay OTC status came as a surprise to Plan B's marketers because less than two months before, two FDA advisory committees recommended that the agency approve the request to change the status from prescription to OTC. It is unusual for the FDA to go against the recommendations of its committees.
Morris & Partners, a Princeton, NJ-based firm, worked with Barr last year to help present its case to the FDA advisory committees. Currently, no agency has been retained to work on Plan B.
Cox said the company is in the process of choosing external counsel. She explained, "We have been interviewing on the OTC front, but if that does not happen, we would pursue a different avenue."