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Why is oral isotretinoin FDA approved for use in women of childbearing age, but not finasteride?

Obviously these are two different drugs with different indications, but both are known teratogens. I know there is an iPLEDGE campaign that goes along with the use of isotretinoin. Would it not be beneficial for Merck to push for finasteride approval in women of childbearing age so that women could use the drug "on-label" rather than the more difficult to get a prescription for "off-label" use?

Doctor Answers (1)

Why do some drugs get approval and others don't

+1
I wish there were a simple answer for this question. A lot of what it comes down to is money, testing, and necessity. Acne affects about 70% of all people some time during their lifetime; thus, acne meds are more abundant. The iPledge program is run through an arm of the government, but it is really cumbersome and difficult. And it took years before it worked decently. A program pushed for finasteride just wouldn't be as "needed" or as used, so it would be expensive and cumbersome, and maybe not all that prolific in use. I agree that there are many cases for finasteride to be used in women. And the drug is great for many things. But I don't see a program coming to fruition like iPledge for it.

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