FDA Draft Guidance Addresses Trial Design for Clinical Lactation Studies

Drugmakers seeking approval of a product intended for use in women of reproductive age should conduct lactation studies on the drug, even in cases when the product would rarely be used in lactating women, according to a new FDA draft guidance.

The guidance provides recommendations for how and when to conduct clinical lactation studies and how to assess the influence of drugs or biologic products on lactation.

Regarding trial design, the agency said the makeup of the study would depend on the clinical question at hand. One of the most effective strategies, the agency said, is using a mother-infant pair design, which allows researchers to assess all of the above objectives. Other trial designs include the study of breast milk only and the study of breast milk and the mother.

In trials not involving children, the FDA stated that sponsors can avoid having to perform lactation studies on the breast-fed child by providing any available data on the drug's effect on pediatric patients.

Regardless of the design chosen, for drugs that are used chronically, the FDA recommended that subjects be studied at steady state. However, for drugs that do not accumulate with chronic dosing, a single-dose study might be sufficient, the guidance states. For drugs that are used to treat acute medical conditions, a single-dose study might be sufficient.

The draft guidance is open for public comment until April 11. To view the document, go to http://www.fda.gov/OHRMS/DOCKETS/98fr/2005d-0030-gdl0001.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/2005d-0030-gdl0001.pdf).