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Pregnancy and Lactation Labeling
In May 2008, the U.S. Food and Drug Administration (FDA) proposed major revisions to prescription drug labeling to more completely inform the use of medicines during pregnancy and breastfeeding. The proposed changes to physician labeling would give healthcare providers better information for making prescribing decisions and for counseling women who are pregnant, breastfeeding, or of child-bearing age.
FDA proposed that both the pregnancy and lactation subsections of labeling include a risk summary, clinical considerations to support patient care decisions and counseling, and a data section that includes more detailed information. The proposed regulations eliminate the current pregnancy categories A, B, C, D, and X due to limitations in their ability to accurately and consistently convey risk and benefit. Information about the use of medicines during labor and delivery would become a part of the "Pregnancy" subsection.
Following publication of the Proposed Rule, there was a 90 day open comment period. FDA received more than 70 comments from private citizens, healthcare practitioners, the academic and scientific communities (including teratology experts), professional organizations, the pharmaceutical industry, and other stakeholders. Many of these comments provided detailed feedback and suggestions on how to further improve the proposed regulations.
As of February 2011, the Final Rule is in the writing and clearance process. This process requires identification and consideration of all issues raised in the public comments. A working group was convened in 2008 to work on these issues and determine whether the proposed regulation should be revised (and if so, how) based on this feedback, the current state of the science, and FDA's current regulatory authority. The rulemaking process has many necessary and important steps. The Pregnancy and Lactation Labeling Rule is an Agency priority and is moving through this process as efficiently as possible. When the Final Rule publishes, there will be a draft Guidance for Industry and information for healthcare practitioners about these important changes.
Proposed Rule - This link goes to Regulations.gov; to see the proposed rule, click on either the HTML or PDF icon under the "Views" column. This link also provides information on how to submit comments.
Summary of Proposed Rule on Pregnancy and Lactation Labeling FDA Proposes New Rule to Provide Updated Information on the Use of Prescription Drugs and Biological Products during Pregnancy and Breast-feeding Pregnant Women to Benefit from Better Information
FDA Consumer Article
Questions and Answers on the Pregnancy and Lactation Labeling Rule Transcript of FDA Media Briefing on Pregnancy and Lactation Labeling Proposal(PDF - 92KB) [ARCHIVED] Fictitious Example – Pregnancy(PDF - 88KB) Fictitious Example – Lactation(PDF - 62KB)
Guidance for Industry
- Clinical Lactation Studies (draft, 2005) (PDF - 363KB)
- Considerations for Developmental Toxicity Studies for Preventive and Therapeutic Vaccines for Infectious Disease Indications
- Establishing Pregnancy Exposure Registries (final, 8/2002) (PDF - 266KB)
- Evaluating the Risks of Drug Exposure in Human Pregnancies (final, 2005) (PDF - 3.1MB)
- Integration of Study Results to Assess Concerns about Human Reproductive and Developmental Toxicities (draft, 10/2001) (PDF - 392KB)
- Pharmacokinetics During Pregnancy and Lactation (draft, 10/2004) (PDF - 324KB)