viernes, 19 de enero de 2018

Clinical Pharmacology Corner: FDA Announces Availability of Draft Guidance, “Labeling for Combined Hormonal Contraceptives”

FDA Announces Availability of Draft Guidance, “Labeling for Combined Hormonal Contraceptives”

On January 2, 2018, the U.S. Food and Drug Administration (FDA) announced the availability of the draft guidance for industry entitled “Labeling for Combined Hormonal Contraceptives”. 

This draft guidance provides recommendations on information that should be included in the prescribing information for combined hormonal contraceptives (CHCs) that contain estrogen and progestin. CHCs include combined oral contraceptives (COCs), as well as non-oral products such as transdermal systems and vaginal rings. Many of the labeling recommendations in this draft guidance represent class labeling that should be included in all CHC prescribing information. The draft guidance reflects many of the modifications to prescribing information mandated by the physician labeling rule (PLR) and the pregnancy and lactation labeling rule (PLLR). General advice is provided where modifications to the prescribing information for specific products are needed.

FDA invites comments on the content of this draft guidance. In particular, FDA seeks comments on the proposed language under section 7.1 of labeling that identifies a drug interaction with all 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 seeks comments and data regarding specific enzyme inducers or classes of inducers (e.g., cytochrome P (CYP) 450 3A strong inducers) that interact with CHCs; in particular, comments are requested on whether the CHC labeling should include specific inducers or classes of inducers, or if it should remain broad and essentially cover all possible CYP enzyme inducers of any pathway and potency.

The “Labeling for Combined Hormonal Contraceptives” draft guidance is available at Please refer to the guidance for more details.

This draft guidance, when finalized, will represent the current thinking of FDA on this topic. In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.

FDA is publishing this draft guidance to collect public comments. You may submit your comments to this guidance by March 5, 2018 to the Docket No. FDA-2017-D-1846 available at Your comments do make a difference and can impact the outcomes of FDA regulatory policy. Share your knowledge and experience, and make your voice count.

No hay comentarios: