Drug Companies To Submit Digital Versions For All Drugs In Coming Year

On November 2, 2005 the FDA announced a new project which will involve drug companies submitting digital versions of drug package inserts, or labels, for posting on a new web site for doctors and patients to use.

The FDA’s digital drug label project is intended to allow for the creation of a new online database which will serve as a centralized source where patients can find up-to-date package inserts, or labels, for all prescription drugs marketed in the U.S.

To start, the FDA’s digital drug label project will require the drug companies to submit all new or changed prescription drug labels in a format suitable for use on an online database. Going forward, the drug companies will be required to submit in digital versions the labels for each of their prescription drugs already on the U.S. market.

As the digital labels are submitted to the FDA they will be placed online at web site which will be called Daily Med — a public online archive maintained by the National Library of Medicine.  The FDA plans to eventually establish its own web site that will post all of the digital drug labels submitted by the drug companies.

According to Andrew von Eschenbach, acting commissioner of the FDA, the goal of this new digital drug label project is to make available to doctors and patients a "timely, user-friendly, available format" by which to learn about the uses and risks of a prescription drug.

In the bigger scheme of things, the FDA’s new digital label requirement is the first part of a broader effort to "improve" the usability of package inserts for prescription drugs.

We know that most patients never see the actual package insert, or label, from the drug company — whether it be the folded-up copy in the pill box, the Physicians’ Desk Reference ("PDR") print-out, or viewed drug company’s web site.  If and when a patient does see the actual drug label, it is far from easy to read.  Even doctors often find the current lay-out of drug labels difficult to use, as they can go on for dozens of pages and highlight relatively obscure information, e.g., a diagram of the drug’s chemical structure.

It is anticipated that later this year the FDA will announce a plan that would completely change the layout and content of the drug labels to make them easier to use and understand.

(Posted by: Tom Lamb)