FDA releases second draft guidance aimed at improving prescription drug labels

Last Updated: 2001-07-06 13:26:35 EDT (Reuters Health)

WASHINGTON (Reuters Health) – The US Food and Drug Administration (FDA) released on Friday a draft guidance aimed at outlining what clinical study results should be included on prescription drug labels.

The draft guidance, which will be published in the July 9 Federal Register, is the second of several draft guidance documents the FDA is planning to release as part of a comprehensive effort to improve the format and content of prescription drug labels.

In June, the FDA also released a draft guidance describing what content and format the agency believes should be used to describe possible adverse reactions to prescription drugs.

These draft guidance documents are part of an overall FDA effort to revise the format of prescription drug labels, which the agency proposed in December 2000.

At present, the FDA is also working on a draft guidance document for the "Warnings/Precautions" section as well as a draft guidance document for the "Pregnancy" subsection.

This latest draft guidance focuses on the "Clinical Studies" section of the label, and outlines how the agency believes these studies should be described and presented in graphs and tables.

For example, the draft guidance suggests that efficacy data from one specific clinical trial should not be included if the overall conclusions differ from the entire database, unless these trials provide additional information that is not otherwise available. This might include information about the drug's effect on certain patient populations.

By establishing this requirement, the FDA said it is also attempting to raise the industry's awareness of what information is appropriate for drug promotions.

The draft guidance is not legally binding, but it does reflect the agency's current stance. Therefore, an alternative approach can only be used if it meets the requirements established under the FDA's proposed regulations.

A full copy of the 19-page draft guidance can be obtained on the FDA Web site at www.fda.gov/ohrms/dockets/default.htm.

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