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news.The FDA has informed Barr Pharmaceuticals that it will postpone its decision on whether or not to grant the company's morning after pill, Plan B, approval to be sold in the US without a doctor's prescription.
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In a letter to the company the FDA said that although the application is supported by scientific data “sufficient to support the safe use of Plan B as an OTC product … for women who are 17 years of age and older,” the agency intends to seek public comment on issues related to the approval of the product.
According to the company, the FDA did not commit to any timetable for initiating or concluding this process.
The issue of contraception, particularly of the morning after variety, is a contentious one in America where it meets with considerable resistance from conservative elements of the population.
“We are disappointed that the FDA did not approve our application. In our submission to the FDA we provided a detailed legal analysis supporting approval of a dual label product and continue to believe that a dual label status can and should be approved for Plan B,” said Bruce Downey, Barr’s chairman and CEO. “While we believe that a delay is not justified, we will use the opportunity presented by the FDA proceedings to continue to press for approval of Plan B as an OTC/Rx Product.”
Plan B emergency contraceptive will remain on the market as a prescription drug product during these proceedings.