The U.S. Food and Drug Administration published a final rule
today that sets standards for how information about using medicines
during pregnancy and breastfeeding is presented in the labeling of
prescription drugs and biological products. The new content and
formatting requirements will provide a more consistent way to include
relevant information about the risks and benefits of prescription drugs
and biological products used during pregnancy and breastfeeding.
The final rule replaces the current product letter categories – A, B,
C, D and X – used to classify the risks of using prescription drugs
during pregnancy with three detailed subsections that describe risks
within the real-world context of caring for pregnant women who may need
“Prescribing decisions during pregnancy and lactation are
individualized and involve complex maternal, fetal and infant
risk-benefit considerations. The letter category system was overly
simplistic and was misinterpreted as a grading system, which gave an
over-simplified view of the product risk,” said Sandra Kweder, M.D,
deputy director of the Office of New Drugs in the FDA’s Center for Drug
Evaluation and Research. “The new labeling rule provides for
explanations, based on available information, about the potential
benefits and risks for the mother, the fetus and the breastfeeding
The final rule requires the use of three subsections in the labeling
titled “Pregnancy,” “Lactation” and “Females and Males of Reproductive
Potential” that provide details about use of the drug or biological
product. The detailed subsections must include a summary of the risks of
using a drug during pregnancy and breastfeeding, a discussion of the
data supporting the summary and relevant information to help health care
providers make prescribing and counseling decisions.
The “Pregnancy” and “Lactation” subsections will also include three
subheadings: “risk summary,” “clinical considerations” and “data.” These
subheadings will provide more detailed information regarding, for
example, human and animal data on the use of the drug, and specific
adverse reactions of concern for pregnant or breastfeeding women.
- The Pregnancy subsection will provide information
relevant to the use of the drug in pregnant women, such as dosing and
potential risks to the developing fetus, and will require information
about whether there is a registry that collects and maintains data on
how pregnant women are affected when they use the drug or biological
product. Information in drug labeling about the existence of any
pregnancy registries has been previously recommended but not required
- The Lactation subsection will provide information about
using the drug while breastfeeding, such as the amount of drug in breast
milk and potential effects on the breastfed child.
- The Females and Males of Reproductive Potential
subsection will include information about pregnancy testing,
contraception and about infertility as it relates to the drug. This
information has been included in labeling, but there was no consistent
placement for it until now.
There are over six million pregnancies in the United States every
year, and pregnant women take an average of three to five prescription
drugs during pregnancy. Women with pre-existing medical conditions, such
as asthma or high blood pressure, may need to continue to use
prescription drugs to treat those conditions during pregnancy and
breastfeeding. Women may also need to take medications for new or acute
conditions that may occur during pregnancy or breastfeeding. The new
labeling format and requirements reorganizes information and is
structured to help inform health care professionals’ prescribing
decisions and the counseling of patients using prescription drugs.
The final rule is part of a broad effort by the agency, which began
with the Physician Labeling Rule, to improve the content and format of
prescription drug labeling.
The rule finalizes many of the provisions in the proposed rule that
the FDA issued in May 2008, and will be in effect as of June 30, 2015.
Once the final rule is in effect, newly approved drug and biological
product applications will be required to use the new format immediately,
while the new labeling content and format requirements for previously
approved products subject to the Physician Labeling Rule will be phased
The FDA is also issuing a draft guidance for industry
to help drug and biological product manufacturers comply with the new
labeling content and format requirements. The draft guidance provides a
detailed description of how the labeling is to be formatted
subsection-by-subsection, noting the type of information that should be
included under each heading. Although comments on a guidance can be
submitted at any time, public comments should be submitted within 60
days of publication to ensure that they are considered when the FDA
begins work on finalizing the draft guidance.
How to Comment on the Draft Guidance for Industry
To comment on the draft guidance on the labeling content and format requirements:
- Read the draft guidance.
- Starting Thursday, December 4, 2014, go to Regulations.gov to submit comments
Final Rule and Draft Guidance
The FDA, an agency within the U.S. Department of Health and Human
Services, protects the public health by assuring the safety,
effectiveness, and security of human and veterinary drugs, vaccines and
other biological products for human use, and medical devices. The agency
also is responsible for the safety and security of our nation’s food
supply, cosmetics, dietary supplements, products that give off
electronic radiation, and for regulating tobacco products.
More Information on FDA.gov
Labels: FDA upate, Treatment pregnancy categories