Though ridiculously simple on the surface, the lettering system has been anything but effective. In fact, Sandra Kweder, deputy director of the Federal Drug Administration's Office of New Drugs, said it "has been highly, highly inconsistent," often contained outdated information and was confusing, the Washington Post reports.
Needless to say, it was time for a change.
So after six years of development, the FDA last week unveiled a shiny new set of requirements aimed at helping doctors and patients make more informed decisions about what they're putting into their body (and their baby's). Chief among them is that drug makers will be required to include information packets with the prescription that spell out any potential risks to pregnant or nursing moms, babies, and small children, or people considering getting pregnant -- plus whatever research backs up those claims. Each packet will contain three clearly marked sections: "Pregnancy," "Lactation," and "Females and Males of Reproductive Potential" for easy skimming.
Starting June 2015, all new prescription drugs and biologics will be subject to the revised system, as will drugs approved by the FDA since 2001 that didn't provide info related to about pregnancy and lactation. (Note that requirements don't apply to over-the-counter meds.)
As someone who pestered her OB with frequent "is-this-safe-to-take" questions during pregnancy and nursing, I think the new rule can't go into effect fast enough. While nothing can replace a quick convo with your healthcare provider, the information packet sounds like a great alternative. After all, when you're pregnant or nursing -- and extra conscious of what's going into your body -- having the most current facts about a medication at the ready can go a long way toward giving you peace of mind.
Now it's your turn: What's your take on the FDA's new requirements for drug manufacturers? How likely are you to read the information packets before taking the medication?