Last week, the US Food and Drug Administration published a final rule that updates requirements for what prescription-drug information must disclose about potential effects for pregnant and breastfeeding women and their babies. Under the old labeling rules, drugs were placed in one of five categories — A, B, C, D, or X — depending on research findings (or lack thereof). An “A” designation meant that human studies did not find adverse effects in pregnant women or their babies, while and “X” designation meant that studies in humans or animals found a risk of problems to the baby and that there were no situations in which the potential benefits of the drug would outweigh the risks. The B, C, and D categories were for drugs with varying levels of evidence; see this Office on Women’s Health fact sheet for more details.
“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, in a news release announcing the final rule’s publication. “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 child.” The news release summarizes three subsections that must provide detailed information:
- 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 until now.
- 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.
An accompanying consumer update notes that women take an average of three to five medications during pregnancy, and that many women have chronic conditions (such as asthma, depression, and diabetes) that require ongoing medication use.
This isn’t the only recent move from FDA to provide more information about how drugs affect various consumer populations. Last month, the agency released Drug Trials Snapshots, which is part of a pilot project to help consumers learn more about the clinical trials upon which new drugs’ approvals are based. It has posted six examples, for drugs approved during a two-month period earlier this year, and is seeking public feedback on their content and utility. Starting next year, FDA aims to post a Snapshot for each newly approved drug classified as a “new molecular entity” (essentially, drugs that are truly novel rather than new versions or combinations of already-approved drugs).
Each of the six sample notes that “subgroup analyses were conducted for sex, race and age,” and then spells out those findings. For five of the six drugs, the results of the sex subgroup analyses were either that reponse “was consistent between men and women” or that the drug “was shown to be similarly effective in men and women.” For the same drugs, limited numbers of non-white participants in the clinical trials meant differences by racial subgroups could not be determined. For the drug Jublia, which treats toenail fungal infections, the snapshot has different answers, though: “A trend towards greater efficacy was observed in women than men taking JUBLIA,” and “A trend towards greater efficacy was observed in Asians than in Whites or Black/African Americans taking JUBLIA.” The Snapshots also give information about the number and demographics of the clinical trial participants, and report whether the trials compared the new drug to standard therapy or to a placebo. To view the Snapshots yourself, scroll down to the chart at the bottom of this page.
Trying to read the inserts that come with prescription drugs can be frustrating or intimidating. With these new actions, FDA is improving accessibility of information that can let us make informed decisions about the drugs we might take.