Thursday, August 15, 2013

FDA Considers Whether Paper Labelling Is Relic of Earlier Time

It's been a decade since the Food and Drug Administration (FDA) mandated that manufacturers submit information via electronic labeling so it would be easily accessible on the Internet and in electronic medical record systems. But a debate has been going on in the agency in recent years over whether to keep paper labeling as well, which now exists as a parallel system. The General Accounting Office (GAO) issued a report on the issue at the FDA's request, but found that the stakeholders were far from a reaching a consensus on the issue. (This issue is not the label on a medication bottle, but the package insert directed at medication prescribers; the patient package insert; and the "Medication Guide," which is also targeted at patients and alerts them to potential risks.)

Manufacturers and some other stakeholders favor eliminating the paper labeling to ensure that the most current labeling is the one people are reading. The paper versions cannot be updated and distributed anywhere near as quickly. This is important as the FDA learns of side effects or approves new indications. Electronic labeling is also easier to read since it can be enlarged on a computer screen. The GAO noted, however, that eliminating paper labeling would require regulatory changes, since federal regulations say that labeling must be included with the medication package. Patient advocates worry that some people don't have Internet access and thus can't read electronic labeling.

To read more about this debate, see the article "Is It Time to Retire Paper Labeling?" in Psychiatric News.

(image: Steve Heap/