Barr and FDA meet today to discuss Plan B

Barr Pharmaceuticals and the FDA are scheduled to meet today to discuss the company’s bid to sell its emergency contraceptive Plan B without a prescription. In a letter sent to Barr last week, the FDA said it would re-examine Barr’s proposed sales of Plan B without a prescription. The agency said Plan B pills would be kept behind pharmacy counters and women would need to ask for them. Women younger than 18 still would need a prescription. The FDA said it hoped to wrap up Barr's application, which has lingered at the agency since 2003, within weeks. Last week, the FDA announced a framework to resolve policy issues associated with Plan B as an over-the-counter option, just one day prior to acting agency commissioner Andrew von Eschenbach’s scheduled testimony at a Senate hearing on his nomination to become permanent agency chief. The committee did not vote on von Eschenbach’s nomination. Sens. Hillary Clinton, D-NY and Patty Murray, D-Wash., have placed a hold on the nomination until the FDA makes a final decision on Plan B.
You must be a registered member of MMM to post a comment.

Did you miss January's Top 40 Healthcare Transformers issue? Read how these inventors, strategists, entrepreneurs and wonks are challenging, disrupting and otherwise transforming the healthcare business. And join us April 30 to honor them at the Transforming Healthcare Dinner. Click here.