Relaxing the rules for Accutane

An FDA panel of experts recommended yesterday that restrictions on Accutane, the acne drug known to cause birth defects, be relaxed a bit to improve patient accessibility. This news also comes just days after preliminary results indicate that the FDA’s required program, iPledge, did not reduce the number of pregnancies despite lots of optimism to the contrary.

None of the recommendations are radical – one involves allowing those who don’t fill their prescription right away to take another pregnancy test and then have it filled (previously they had to wait 23 days), while the second allows the prescription to be filled within seven days of the pregnancy test instead of being tied (time-wise) to the doctors’ visit. Additionally, they are only recommendations, meaning the FDA may choose not to adopt these measures (Plan B anyone?)…though this sees unlikely given how benign the proposals appear.

Restrictions that are still in place include the mandatory 2 forms of birth control, although an exception is made if the woman pledges abstinence (or obviously if she is not of child-bearing age). 122 women became pregnant last year while taking the drug, which is practically a drop in the bucket when one considers the 90,000+ women who received at least one prescription in that time. Of those 122 pregnancies, 72% were on the required birth control, and 18% had been relying on abstinence. To me this proves two points: birth control is never 100% effective, and pledging abstinence does not prevent some people from engaging in sexual activity.


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