Lauran Neergaard of the AP is reporting that an audit of the FDA by the Government Accounting Office (GAO) raises some troubling questions about just how they came to decide that “Plan B” (levonorgestrel .75mg) was unsafe for OTC deployment.
A congressional audit released Monday cited “unusual” steps in the FDA’s initial rejection of over-the-counter emergency contraception, including conflicting accounts of whether top officials made the decision even before scientists finished reviewing the evidence.
The FDA is reconsidering the decision on the pill, sold under the brand Plan B. While the report by the Government Accountability Office, Congress’ investigative arm, doesn’t say that FDA made the wrong decision, it does raise the most serious questions to date about agency credibility – and increases pressure to settle the issue.
In May 2004, FDA leaders rejected the nonprescription switch, saying there was no data proving anyone under 16 could safely use the pills without a doctor’s guidance.
Maker Barr Laboratories reapplied, seeking to sell Plan B with age limits similar to those required for cigarettes: Females 16 or older could buy it without a prescription but younger teens would continue to need a doctor’s note. In August, FDA leaders postponed a decision indefinitely, saying it wasn’t clear how to enforce an age limit.
The result was unprecedented public discord from the normally secretive agency: Top-ranking FDA officials have acknowledged they overruled their own scientists’ decision that nonprescription sales would be safe, and the women’s health chief resigned in protest.