What To Expect When You’re Expecting has become bedside reading for many pregnant women. For curious regulatory professionals, there’s no book yet titled “What To Expect When You’re Expecting To Submit An Application For FDA Approval,” but FDA has just published a proposed rule that might fit well under that title. The proposed rule would specify how information about pregnancy and lactation should appear in product labeling.
The reg would scrap FDA’s current five-sizes-fit-all category system. Drugs wouldn’t be rated X anymore, but they couldn’t score an A either; FDA feels the categories oversimplified many risk issues, especially the question of whether the information was based on human or animal studies. In place of the categories, FDA would call for more narrative description to put a product’s potential side effects in the context of the background risks of birth defects and the dangers of not treating a condition.
The new labeling could lead to wider prescribing during pregnancy. The agency is aware of that and is simultaneously asking drug sponsors to provide better data collection about products. It’s another sign of how FDA wants to use a better post-marketing system to allow access to even drugs with outstanding safety issues.
One part of the reg that caught our attention was the prominence given to asthma. In a portion of the document discussing the importance of treating chronic diseases during pregnancy, asthma has its own section. “Other chronic conditions” -- including diabetes, hypertension and epilepsy -- are all lumped together in the next section.
Also, the first example of a mock label showing what the new format would look like uses a made-up asthma drug, Alphathon. “Prescribers should consider alternative treatments,” the fictional example states. In all, asthma is mentioned 15 times in the proposed rule, compared to five times for diabetes.
Whether this leads to a heavier dose of relabeling for asthma drugs remains to be seen, but sponsors should be on notice: This regulatory action is now more than just a twinkle in the agency’s eye.