SWHR Praises FDA Draft Guidance on Lactation Study Design

Policy Engagement

Published 7/8/19

SWHR sent comments to the Food and Drug Administration (FDA) regarding the agency’s new draft guidance on pre- or post-market clinical lactation study design. SWHR praised the FDA for issuing unique guidance on this issue, given that more than 80% of new mothers attempt to breastfeed following delivery of their child. Despite this, there is a lack of human data on drug safety and efficacy within lactating women.

In its comments, SWHR supported HHS interagency collaboration to advance research within this population. SWHR also encouraged the use of lactation studies whenever such a study is deemed appropriate, and not only when the FDA requires such a study. This should be determined on a case-by-case basis, including:

  • When a drug under review is expected to be used by women of reproductive age
  • After approval, should use of the drug by lactating women become evident
  • If a new indication is sought for an approved drug and there is anticipation of the drug’s use in lactating women
  • For already-marketed medications commonly used by women of reproductive age

Read SWHR’s Comments