FDA Comments on ProposedPrescription Drug Labeling

FDA to Receive Comments on Proposed Implementation of Prescription Drug Labeling Improvement and Enhancement Initiative

By Dr. Nicholas Fleischer & Claire Robertson

Standardized prescription drug labeling was implemented by FDA in 1979. In the following years as labeling became more complex, FDA re-evaluated its usefulness and published a final rule in 2006 titled “Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products,” commonly referred to as “Physician Labeling Rule (PLR).” This rule applies to products for which an NDA, BLA or efficacy supplement (ES) was approved between June 30, 2001 and June 30, 2006 and to NDAs, BLAs, and ESs submitted after June 30, 2006. It also established a staggered implementation schedule for groups of drugs to be converted to PLR format over time. This implementation process is set to expire on June 30, 2013.

According to the Federal Register notice published February 6, 2013, as of November 2012, approximately 15% of all prescription drugs and biological products had labeling in PLR format. As far as generic drugs, only 10% of labels have been converted to PLR format as those approved under an ANDA are not required to convert to PLR unless the reference listed drug (RLD) approved in an NDA has converted to PLR format.

In an effort to “increase the number of drugs with labeling that complies with the PLR content and format requirements,” FDA announced the Prescription Drug Labeling Improvement and Enhancement Initiative. For generic drugs in particular, FDA “believes that it is in the best interest of the public health to facilitate conversion of generic drug labeling to the PLR format so the labeling is equally useful to prescribers as the labeling for more recently approved drug products.” This could raise the possibility of FDA requiring generic drugs to use the PLR format in cases where the RLD has been withdrawn or even for new generic approvals where the RLD is not in PLR format.

According to FDA, if action is not taken, “the only additional drug products with labeling in the PLR format will be new NDAs, BLAs, and ESs, which are required to be submitted in PLR format, and labeling for drug products for which the NDA or BLA holder voluntarily converts to PLR format.” Overall, the PLR format allows physicians and pharmacists a modern and accurate means of obtaining current information on the safe and effective use of drugs. This initiative will take place over the next few years and FDA is currently soliciting public comments.

Written by Nick Fleischer, R.Ph., Ph.D., Vice President, Clinical Pharmacology & Biopharmaceutics, and Claire Robertson, Marketing Associate. For more information, please contact Dr. Fleischer.