Hormonal Contraceptive Labeling: FDA Issues Draft Guidance

Posted 03 January 2018 | By Michael Mezher 

Hormonal Contraceptive Labeling: FDA Issues Draft Guidance

The US Food and Drug Administration (FDA) on Tuesday issued new draft guidance providing labeling recommendations for hormonal contraceptives in line with requirements from the agency's 2006 physician labeling rule (PLR) and 2014 pregnancy and lactation labeling rule (PLLR).

FDA had previously issued draft guidance on combined oral contraceptive (COC) labeling in 2004, but withdrew the guidance in 2015. However, FDA says it took comments submitted to the 2004 draft guidance into consideration when drafting the current guidance.

FDA also says it has broadened the new draft guidance to cover combined hormonal contraceptives (CHCs) as a class, which includes COCs and non-oral hormonal contraceptives, such as transdermal patches or vaginal rings, as many of the labeling considerations are relevant to various routes of administration.

"Because all CHCs contain an estrogen and a progestin, FDA believes that class labeling based on the information known about estrogens/progestins generally is appropriate for many sections of CHC labeling," FDA writes.

The guidance itself provides specific recommendations for the information that should be contained in the labeling for all CHC drugs, and notes specific parts of the labeling that will need to be completed with product specific information.

While FDA is seeking comments on the draft guidance, the agency says it is particularly interested in comments and data on section 7.1 concerning drug interactions with metabolic enzyme inducers.

"A variety of metabolic enzyme inducers have been reported to decrease the plasma concentration of the estrogen and/or progestin components of CHCs," FDA writes, noting that it is looking for input and data on both specific enzyme inducers and classes of inducers that interact with CHCs.

Federal Register Notice, Draft Guidance

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