FDA Delays Emergency Contraception Decision

FDA Commissioner Lester Crawford released a statement today indicating that the agency would delay a decision on Barr Laboratories' application to make Plan B emergency contraceptive availalble over the counter to women 16 years of age or older. The rationale for the decision is that "What we are saying today is that the Agency is unable at this time to reach a decision on the approvability of the application because of these unresolved regulatory and policy issues that relate to the application we were asked to evaluate," the regulatory issues being whether a drug can have both prescription and over the counter status at the same time, whether the two could be "marketed in a single package," and how the limitation would be enforced.

I'm not sure why these are such big issues - we enforce age limits on other products through carding, and the same-package-for-different-status problem seems somewhat trivial. As for being both OTC and prescription, the release doesn't really explain the rationale for that being a problem, except that "If it needed a prescription for one group of people, then it needed a prescription for all people. That was FDA’s practice for a very long time." Barr submitted the new application to exclude younger women because their initial application was rejected due to the FDA's concern over a lack of safety data for the drug in younger women. Barr released their own response to the latest decision here. CNN also covers the story with varying reactions.

The FDA states that there will be at least a 60-day delay in order to receive public comments: "We are beginning a process that will address the regulatory questions today, but we believe we can only decide these issues in an open, public process. Through this process, all interested parties can weigh in on the questions of whether a drug may be both prescription and over the counter based on uses by different subpopulations and whether the prescription and over the counter versions of the drug may be marketed in a single package." Information on submitting comments is available as a PDF at http://www.fda.gov/bbs/topics/news/2005/cd0584.pdf FDA does have an online commenting feature, but todays docket isn't loaded yet. I'll update this post with the link when commenting is available on this issue.
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