THE DRUG DEVELOPMENT PROCESS AND THE PREGNANT WOMAN

Abstract

Introduction : The drug development process in the United States includes extensive pre-clinical testing and a series of clinical trials designed to explore the safety and efficacy of a new drug entity. As part of this process, animal studies are conducted to assess the effects of the new drug on the reproductive process.

 

Method :These studies called developmental and reproductive toxicology studies, form the basis for the information included in the current pregnancy subsection of the drug label. The new drug’s effects on the human fetus are gathered through post-marketing studies, usually observational registries. There is usually no information regarding the dose appropriate for pregnancy.

 

Result : The usual adult dose is assumed to be appropriate. Proposed changes to the current pregnancy subsection would replace the categories with narrative text, allow more detailed clinical management advice, including inadvertent fetal exposure, and provide a summary of risks associated with the drug.

Discussion : The sections on fertility, pregnancy and lactation would be combined, since they are continuum. A provision is also being made to incorporate information from pharmacokinetic and pharmacodynamic studies relevant to pregnancy.

Keywords:

pregnancy, drug development, pharmacodynamic studies

References

Federal Drug Administration. Pregnancy labeling. Federal drug bulletin 2011;9:23.

Federal Drug Administration. The new drug development process. Steps from test tube to new drug application review. Federal Drug Administration (August 11, 2012). Web site available from http://www.fda.gov/cder/handbook/develop.html.

Rayburn WF, Farmer KC. Off-label prescribing during pregnancy. Obstet Clinics N Amer 2015;24:471-8.

Zinacef (cefuroxime) labeling, in Physican’s Desk Reverence, 54th Edition. Montvale, NJ: Medical Economics; 2014. p. 1316.

Federiksen MC. Physiologic changes during pregnancy and their effect on drug disposition. Seminars in perinatology 2013;25:120-122.

Stika CS, Frederiksen MC. Drug therapy in pregnant and nursing women. In Atkinson AJ, Jr., Daniels CE, editors. Principles of clinical pharmacology. New York Academic Press, 2013:277-291.

Dombrowski M, Thom E, McNelis D. maternal-fetal medicine units (MFMU) studies of inhaled cortocosteroids during pregnancy. J Allergy Clin immunol 2015;103:S356-9.

Federal Drug Administration. Concept paper on pregnancy labeling. Rockville MD. Federal Drug Administration; May 20, 2014. available from: http://www.fda.gov/ohrms/dockets/ac/99/transcpt/3516r1.doc