FDA Finds Drug Relabeling Initiative More Difficult Than Expected

The U.S. Food and Drug Administration (FDA) has placed its drug relabeling initiative contract with Reed Tech on hold after it ran into unforeseen complications, sources connected to the matter told Regulatory Affairs Professionals Society (RAPS).

The federal agency’s Prescription Drug Labeling Improvement and Enhancement Initiative (PDLIEI or PDLI-EI) was launched in 2013 to address outdated standards in drug labeling. As RAPS reported upon the initial launch of the initiative, prescription drug labels have devolved into lengthy, overly elaborate, and complex documents that aimed to avoid possible litigation rather than serve their ultimate purpose: to communicate reader-friendly medical information. The older format failed to identify the approval date of the drug and inform users of any recent changes in labeling. The complicated nature of the label also hindered readers from easily accessing needed information and made it difficult to answer specific questions.

The FDA addressed these issues with the PDLIEI, which aimed to shorten and simplify drug labels. Under the initiative, it was specified that labeling highlights should be no longer than half a page, including warnings and indications formatted into bulleted boxes. The labels should also identify any major changes and include the date of U.S. approval. In addition, drug labels should emphasize readability and focus on presenting the most important information. Along with providing patients with the necessary medical information, it also became a requirement that labels contain contact information for adverse event reporting. The new labeling rules apply to all drugs approved between 2001 and June 2006 and thereafter.

Reed Technology, member of the LexisNexis family of companies, was chosen last year to facilitate the conversion of prescription drug labeling over the course of five years. Reed Tech’s role was to work with companies to transition their current labeling into the new format, which would then be subject to FDA approval as a supplemental NDA. The contract was valued at $26 million at the time of its awarding. However, the FDA said that the program has since run into difficulties and is more complicated than what was expected at first.

Though the agency would not confirm that its contract with Reed Tech was on hold, an FDA spokesman told Focus that the 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.” He also assured that “The Prescription Drug Labeling Improvement and Enhancement Initiative (PDLIEI) is currently ongoing.”