FDA to finalize labeling guidance


The US Food and Drug Administration (FDA) has announced that it has completed its guidelines for clinical pharmacology sections relating to drug, generic drug and biologic labels. The new guidelines will determine the data to be included on labeling, as well as changes for specific products.

The guidelines have been in development since the release of their initial draft version in 2009. A revision in 2014 aimed to clarify certain rules; however, calls have continued to be made for greater legibility. The latest version aims to address many of these criticisms and alleged inconsistencies.

One of the most significant changes comes in the section on information contained in subsections for clinical pharmacology, a common sticking point which has been criticized for its perceived lack of clarity. The FDA now stipulates that dosages outside recommended ranges should be expressed proportionally, compared to the limits of the recommended range.

Other changes concern the labeling of specific drugs; for example, the CHANTIX/Pfizer drug varenicline will no longer contain a warning on the neuropsychiatric risks associated with patients who use the drug to help them stop smoking. The changes have been justified for various reasons. In this case, the FDA cited a Lancet report on a large clinical trial of smoking cessation in mental health patients, which eased concerns over the drug. Other similar drugs have also had labeling restrictions removed.

In addition, the FDA has moved to cut down on bureaucracy by allowing companies “minor formatting changes” without the need to submit a labeling supplement, merely requiring the update to be logged in annual reports. The FDA goes on to state that this is “not a regulatory requirement or a safety issue.”

The reaction to the latest guidance will be interesting to follow, although the aim is certainly to assist and aid larger pharmaceutical companies by removing restrictions where evidence has suggested it is safe to do so. With criticism over restrictive labeling continuing to grow, it may turn out to be a popular





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