The FDA’s Unfortunate About Face

In 2004, the Food and Drug Administration (FDA) stood up to outside pressures and rejected a petition by Barr Pharmaceuticals to allow the morning-after pill to be sold over-the-counter.  At the time, the FDA cited concerns about the lack of research on the potential effects of the drug on the health of adolescent girls.

The fact that those concerns remain unanswered makes it hard to understand the agency’s about face yesterday.  Instead of answering the questions raised by the 2004 petition, the FDA decided to disregard them completely and create a dual-marketing scheme that puts Barr’s profits above the safety of our children. The plan approved by the FDA creates a two-tier system that allows adults to purchase the drug over-the-counter, but requires minors to have a doctor’s prescription.  This is an entirely new type of approval that has not been authorized by Congress and has not undergone a formal rule-making process.

This scheme puts the health of adolescent girls at risk. Despite claims by the FDA and Barr laboratories that this policy protects children, under this approval the drug can be easily obtained and redistributed to kids while research about its dangers remains inconclusive.

Yesterday's decision by the FDA is misguided to say the least. Approving the sale of a controversial drug under this strange arrangement, without Congressional input, and without clear guidelines for enforcement sets a dangerous precedent.  In essence, the FDA has fashioned new complicated and unclear standards for prescription drug approval based on one individual drug application.