The US Food and Drug Administration (FDA) has awarded a contract worth $26 million over five years to modernize many drug labels that do not conform to a new labeling standard known as the Physician Labeling Rule (PLR), the awardee has announced.
The PLR modernization program was first announced in February 2013, with the agency citing a cacophony of labeling standards still in existence thanks to a grandfathering provision within the PLR when it was passed in 2006.
Under the PLR, labeling highlights could be no longer than a half page including the bulleted boxed warning and indications, must contain a "Table of Contents" for easy referencing, must identify all major changes and must include the date of initial US approval. 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. The problem, according to agency officials, is that many companies did not choose to update 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."
A New Initiative
As a result, FDA endeavored to establish the groundwork for a new policy initiative known as the Prescription Drug Labeling Improvement and Enhancement Initiative (PDLI-EI), a five-year project to be run by an outside contractor.
[See Regulatory Focus' 11 July 2013 story, "FDA Looks to Update, Improve Labeling of Existing Drug Products."]
Under the program, the selected contractor would look to increase compliance with the PLR standard by working with companies to convert existing labels to the PLR to create a labeling supplement, which could then be approved quickly by FDA. The overall intent is to reduce the amount of work to be done by industry, while at the same time increasing the quality of submissions to the agency to cut down on agency review time.
FDA said it expects the contractor to submit no more than 25 PLR labeling conversions per month for at least 295 prescription drugs over the course of the contract. However, as Focus noted at the time, the contract notice also included a statement that FDA is interested in "other labeling and enhancement projects throughout the five-year period of the contract."
"Other examples of labeling enhancements could include developing, testing, or evaluating patient labeling, facilitating the accessibility and use of the FDA-approved electronic prescription drug labeling, evaluating and drafting revisions to prescription drug labeling in PLR format, or obtaining and summarizing feedback from the public on user preferences and usefulness of prescription drug labeling (e.g. through public meetings, workshops, or other means)," it wrote.
And the Winner is…
Now we know both the name and the total cost of the PLR-EI project. In a press release on 9 October 2013, Reed Technology, a subsidiary of information technology giant LexisNexis, announced it had secured the five-year, $26 million (estimated) contract.
"Reed Tech is delighted to offer these services to the FDA," wrote Ben McGinty, senior director of the company's Life Sciences division. "We look forward to helping the FDA fulfill its vision of updating prescription labels to a standard that communicates critical information more clearly, for more effective and safe administration of these medicines."
Reed said it had "extensive experience" in related government contracting areas, most notably supporting FDA's structured product labeling (SPL) standard for more than 700 customers. In addition, Reed supports the US Patent and Trademark Office (USPTO), which processes many pharmaceutical technology patents.
The question now: When does this program begin, and what can industry expect from the process? Focus reached out to McGinty for further comment, but he was en route to Silver Spring, MD to meet with FDA and was unable to answer our questions by the time of press. We'll try to have more information for you later this week.