FDA Public Meeting Report on “Drug Interactions With Hormonal Contraceptives: Public Health and Drug Development Implications”

Mohammad Akbar, Erin Berry-Bibee, Diana L. Blithe, Ruth S. Day, Alison Edelman, Joachim Höchel, Roxanne Jamshidi, Myong Jin Kim, Li Li, Vivek S. Purohit, Jim A. Turpin, Pamela E. Scott, David G. Strauss, Haiying Sun, Naomi K. Tepper, Lei Zhang, Chongwoo Yu

Research output: Contribution to journalArticle

3 Scopus citations

Abstract

Potential drug interactions with hormonal contraceptives are an important public health concern. A public meeting on “Drug Interactions With Hormonal Contraceptives: Public Health and Drug Development Implication” was hosted by the United States Food and Drug Administration (FDA). The meeting endeavored to provide an opportunity for the FDA to seek input from experts on the public health concerns associated with the use of hormonal contraceptives and interacting drugs that might affect efficacy and safety, including pharmacokinetic/pharmacodynamic considerations, in the design of drug interaction studies of hormonal contraceptives for drug development and approaches to translating the results of drug interaction information into informative labeling and communication. The input received could be used to refine FDA's thinking on hormonal contraceptives drug interaction study design and interpretation and labeling communication of drug interaction risk. This meeting benefited from strong and diverse participation from the Center for Drug Evaluation and Research at the FDA, Centers for Disease Control and Prevention, National Institutes of Health, Swedish Medical Products Agency, pharmaceutical industry, and representatives of academia. This report provides a summary of the key discussion based on the presentations and panel discussion.

Original languageEnglish (US)
JournalJournal of Clinical Pharmacology
DOIs
StateAccepted/In press - Jan 1 2018

Keywords

  • drug development
  • drug interaction
  • hormonal contraceptive
  • labeling and communication

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

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    Akbar, M., Berry-Bibee, E., Blithe, D. L., Day, R. S., Edelman, A., Höchel, J., Jamshidi, R., Kim, M. J., Li, L., Purohit, V. S., Turpin, J. A., Scott, P. E., Strauss, D. G., Sun, H., Tepper, N. K., Zhang, L., & Yu, C. (Accepted/In press). FDA Public Meeting Report on “Drug Interactions With Hormonal Contraceptives: Public Health and Drug Development Implications”. Journal of Clinical Pharmacology. https://doi.org/10.1002/jcph.1285