> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Ways to Improve Drug Labels: Pitts
- URL: https://www.fdaweb.com/ways-to-improve-drug-labels-pitts/
- Published: 2016-10-20T12:00:00.000Z
- Updated: 2026-09-14T21:41:06.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137137

Former FDA associate commissioner **Peter Pitts** says that FDA could follow principles to improve drug labeling in a way that would make it easier for doctors to determine if off-label prescribing would be good for their patients. Writing in a *Forbes* online [post](http://www.forbes.com/sites/realspin/2016/10/20/fda-labeling-rules-keep-doctors-in-the-dark/?ref=fdaweb.com#2fb1de4b3ad7), he notes that drug companies continue to collect reams of data about their drugs long after clinical trials have been concluded. And other information can be found in insurance claims, patient registries, and electronic medical records.

“These kinds of data could make it far easier for doctors to determine whether an off-label prescription is appropriate and, if so, which one,” he says. “Unfortunately, FDA’s strict labeling requirements prevent such information from appearing on a drug’s label. The agency can address this flaw by relaxing its labeling rules while enforcing several basic principles to ensure that any labeling information is clear and accurate.”

Pitts’ principles are: 

- companies should be required to provide ample context for any information not found in the FDA-approved label, such as a study’s format, limitations, and details of its statistical analysis; and
- labeling information should be tailored to the unique needs of various healthcare providers.