The FDA has offered more suggestions on product labelling with its latest draft guidance focused on a label’s indications and usage section, recommending drug companies make their language as clear as possible to help doctors prescribe the right medicine to patients.
The indications and usage section requires drugmakers to state that a drug is indicated for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, including treating symptoms. This means the section can only say the product treats, cures, or prevents a certain disease.
In its latest guidance, the FDA suggested expanding the scope of indications and usage to include broad age groups, stating, for instance, that a drug has been approved to treat a disease in children under age 18.
The guidance also outlined situations in which drugmakers can include an indication that is broader or narrower than the clinical studies of a drug. For instance, an indications section could be widened to include the broader population if a drug was studied in patients with a moderate case of a disease, but data also shows it could treat mild or severe cases.
However, this recommendation only goes so far. The guidance says trials where patients are enrolled based on a specific genomic marker only prove the effectiveness within that population, and drug makers would need additional study to broaden the indication.
The draft guidance is open for public comment until September. This is the second guidance on product labelling that the FDA has released this year. The earlier document covered the product title and initial U.S. approval part within the highlights of the prescribing information label section.