Questions and Answers on the Pregnancy and Lactation Labeling Rule
- Why is FDA issuing this final rule and when does it take effect?
The final rule addresses the shortcomings of pregnancy and lactation information in prescription drug labeling. Extensive stakeholder input was obtained as part of the rulemaking process, including the convening of a public hearing and advisory committee meetings, outreach to focus groups and the opening of a docket to receive comments from the public. The rule finalizes a proposed rule issued by the FDA in May 2008. There is a pre-specified period of time between the time the final rule is published and the time that the final rule becomes effective. The final rule goes into effect June 30, 2015.
- What are the major changes between the 2008 proposed rule and the final version?
The major concepts outlined in the proposed rule are part of the final rule. Very little has changed as to the type of information on pregnancy and lactation that will be included in labeling. The information has been re-organized and some of the titles and headings have changed to help clarify the information found in each sub-section.
Specific changes from the proposed rule to the final rule include the following:
- A new subsection, 8.3 Females and Males of Reproductive Potential was added to provide a consistent format and location for inclusion of relevant information for health care providers about pregnancy testing, contraception, and infertility.
- The use of standardized risk statements was eliminated, as these had the same limitations as the letter categories; furthermore, many of the docket comments to the proposed rule noted these limitations.
- The section on inadvertent exposure was eliminated as the risk information would not change regardless of whether the exposure was intentional.
- Why are the Pregnancy Letter categories being removed from drug labeling?
FDA has decided to eliminate the pregnancy categories because they are often viewed as confusing and overly simplistic and don’t effectively communicate the risk a drug may have during pregnancy and lactation and in females and males of reproductive potential.
- Does the PLLR affect all drugs?
All prescription drug and biological products that are required to follow the Physician Labeling Rule (those approved since June 30, 2001) must revise the content and format of their pregnancy and lactation sections in labeling according to the implementation schedule published in the rule. For labeling of products approved prior to June 30, 2001, manufacturers are required to remove the pregnancy category within 3 years of the effective date of the final rule.
Labeling for over-the-counter (OTC) medicines will not change. OTC drugs are not affected by the PLLR.
- Where will the data in the prescribing information come from?
The data could come from various sources, including well-conducted studies published in the medical literature about the use of prescription drugs and biological products during pregnancy and breast-feeding. Companies will be required to include clinically relevant information from such published studies in the labeling. Another source of data could be from pregnancy exposure registries, which are conducted by some companies to collect information on the effects of their approved drugs when those drugs are used by pregnant women to treat a medical condition.
- Is the information in the drug labeling understandable to consumers? What is the best source of information for consumers about appropriate and safe use of medications during pregnancy and lactation?
Although physician labeling is directed at health care professionals, it is sometimes adapted for use in consumer-directed resources, such as patient package inserts (PPI) or patient medication guides. While there is much information in labeling, PPIs and medication guides, the best source of information is talking to one’s health care professional.
- Can you explain more about pregnancy registries and how they work?
A pregnancy exposure registry is an observational study that collects health information from women who take prescription drugs or vaccines when they are pregnant. The FDA does not conduct pregnancy exposure registries but may recommend or require that a drug company implement a pregnancy registry based on certain criteria. The FDA’s Office of Women’s Health keeps a list of registries, posted on FDA’s website. There are registries for a number of drug products, for example drugs for cancer, epilepsy, arthritis, diabetes and psychiatric conditions.