FDA to require simple patient drug labeling

September 19, 2023

We’re all familiar with the almost comical lists of potential drug side effects flashing across a TV screen at the end of a commercial or the page of unreadably small font text next to a magazine ad for a pharmaceutical product. Drugs are packaged with “patient product inserts” with indications and warnings that are folded four times and written so small that I can barely read them with my reading glasses. These generally don’t help make pharmaceutical use safer or consumers more educated, since no one reads them!

The Food and Drug Administration asked for public comments this week on new regulations that would require a single, highly-readable page of explanation (a Medication Guide) to be supplied with every prescription. Comments are due in late November, and final regulations will be published after that. We don’t know exactly how these information sheets will look, but it won’t take much to make them more informative than what we have now.

These regulations have been a long time coming! They were first proposed in 1979, and multiple studies performed since then have shown that available patient information is incomplete and ineffective. They also will take a long time to take effect, assuming that the FDA does not withdraw them. The regulations become effective six months after they are published, and the FDA will allow those who distribute drugs two years of lead time to establish procedures for distributing the Medication Guides. Drugs already on the market have up to five years to submit Medication Guides to the FDA.

This is an important opportunity to better educate patients about the drugs they take. These regulations could also promote meaningful patient conversation with physicians about medications that are prescribed.

Implications for employers:

-        These regulations will provide more accessible and useful information to plan members when they pick up prescriptions in the future.

-        The regulations are not likely to have a significant impact on drug utilization or cost, and compliance costs for industry appear modest.

-        These regulations could lead to fewer people seeking medical treatment for improper use of medications, and could help increase adherence since people are more likely to continue to take a drug if they understand why it is prescribed.

Tomorrow: Doctors don’t suggest colorectal cancer screening to their patients

Illustration by Dall-E

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