Regulatory Focus™ > News Articles > FDA Initiative to Re-Label Older Drugs Hits Significant Setback: Sources

FDA Initiative to Re-Label Older Drugs Hits Significant Setback: Sources

Posted 26 August 2014 | By Alexander Gaffney, RAC 

FDA Initiative to Re-Label Older Drugs Hits Significant Setback: Sources

A multi-year, $26 million program launched last year by the US Food and Drug Administration (FDA) is now being partially shelved after running into significant difficulties, FDA sources tell Focus.

Background

The program, known as the Prescription Drug Labeling Improvement and Enhancement Initiative (PDLIEI or PDLI-EI) began in February 2013 when FDA announced its creation in the Federal Register and solicited public feedback on its goals.

Simply put, the program is an attempt to update older drug labels that were grandfathered into older formats when the 2006 Physician Labeling Rule (PLR) went into effect. The rule is intended to highlight the most important benefits, risks and qualities of a drug, thereby making it easier for physicians and patients to understand whether and how a drug should be used.

The rule also implemented new formatting requirements, such as a table of contents, an 8-point minimum font size and other typography requirements intended to make the label easier to read.

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.

FDA noted in subsequent statements that only about 15% of all drug products on the market conform to the PLR's requirements, and that a lack of conformity has the potential to harm patients and even disrupt the adoption of electronic health technologies.

PDLIEI Proposal

FDA's PDLIEI was intended to alleviate this problem by creating a voluntary system in which companies could work with an FDA-approved contractor to transition their existing labeling to a new format, which would then be approved by FDA as a supplemental NDA (sNDA).

The five-year contract was estimated at a value of $26 million, according to Reed Tech, the company which won the PDLIEI contract from FDA, and Drug Safety Navigator, a Reed Tech subcontractor. FDA records indicate that it has only spent $3.9 million on the PDLIEI program so far.

As of December 2013, FDA staff still listed the program as a priority for the agency.

Program Shelved

But according to FDA sources, the agency's PDLIEI contract with Reed Tech is now on hold. One source told Focus that the program was proving to be significantly more complicated than initially anticipated, causing the agency to rethink its approach to relabeling products.

FDA spokesman Stephen King would not confirm that the PDLIEI contract was on hold, but told Focus that FDA "remains committed to increasing the number of older drugs with labeling that complies with the PLR and continues its efforts toward meeting the goals of PDLIEI."

"The Prescription Drug Labeling Improvement and Enhancement Initiative (PDLIEI) is currently ongoing," he added.

Reed Tech did not respond to repeated requests for comment.


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