FDA Moves Forward With Drug Labeling Revision Project

| 06 May 2014 |  By 

The US Food and Drug Administration (FDA) is out with new information about an initiative first announced in 2013 that is meant to convert the labeling of hundreds of older drugs into a newer and consumer-friendly format.


In 2006, FDA passed the Physician Labeling Rule (PLR), a labeling format intended to make it easier for physicians and patients to understand some of the most important benefits and risks of a drug.

For example, labeling highlights under the PLR are limited to half a page, including bulleted boxed warnings, and labels must also contain a "Table of Contents" and identify all major changes made to the label over time.

The label was also reformatted to allow for the most pertinent information to be more prominent, and established 8-point minimum font and other typography requirements to make the type easier to read. Notably, the new labeling also included contact information (phone number and a website address) to facilitate adverse event reporting.

The rule applies to all products approved under a New Drug Application (NDA), Biologics Licensing Application (BLA) or efficacy supplement (ES) approved between 2001 and 30 June 2006, as well as all products thereafter.

However, older drugs did not need to comply with the PLR, but could instead subject themselves to the rule on a voluntary basis, FDA said.

That, however, has resulted in a problem for regulators and patients alike. Many companies have not yet updated their labeling. At present, only about 15% of all drug products on the market conform to the PLR, and FDA said in a statement that it was concerned that its efforts to convert labels had run short of expectations.

"If no further action is taken," FDA said, "the only additional drug products with labeling in the PLR format will be new NDAs, BLAs and ED, which are required to be submitted in that format."

New Effort to Update

So in February 2013, FDA launched a new initiative known as the Prescription Drug Labeling Improvement and Enhancement Initiative (PDLI-EI), a five-year project to be run by an outside contractor, LexisNexis.

See Regulatory Focus' 11 July 2013 story, "FDA Looks to Update, Improve Labeling of Existing Drug Products."

At its most basic, the PDLI-EI is intended to increase compliance by having the contractor do the work-and assume some of the cost-for the companies, which presumably wouldn't otherwise do so on a voluntary basis.

However, FDA has also said it hopes to use the project as an opportunity to make some improvements to the labeling process, such as by better understanding how labeling information is used by the public.

New Information

Now the agency is out with still more information explaining more details about the PLR conversion process. In a 6 May 2014 Federal Register notice, FDA says it expects to first approach companies to become involved in the program, which will then need to submit a proposed revision to the draft labeling.

FDA's language in the Register notice seems to indicate its intent to target holders of new drug applications (NDAs) with one or more generic drugs, as changing the labeling of that single NDA would require all others to change their labels as well.

Though approximately 750 prescription products fall outside of the PLR, FDA estimates that it will be contacting 375 application holders. The agency did not explain why approximately half of all grandfathered products would be ignored.

Submissions will take different amounts of time to complete, depending on the type of product. Innovative products approved under an NDA will take just shy of 200 hours to complete a labeling revision, while generic drug products will take an estimated 27 hours.

Because some products will require new packaging to accommodate longer inserts, some companies will responsible for incurring those costs as well, FDA said.

Federal Register Notice


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