By Suzanne Hodsden
The FDA has issued a proposed rule which will require drug makers to electronically submit and monitor all labeling information for marketed drugs. The agency will keep an online repository of the information and its updates, which would be available to doctors immediately, The Regulatory Affairs Professionals Society (RAPS) reports.
Currently, prescribing information and updates to a drug’s safety profile are delivered on paper — a process that can take months or even years. Furthermore, this method has the potential to cause problems when out-of-date literature continues to circulate while the drug makers work to distribute updates.
A new electronic system would make the dissemination of this information much quicker, allowing doctors to receive new information critical for effective use of the product almost as soon as it is released. Additionally, the move cuts down on a considerable amount of paper waste.
The new system requires drug makers to submit all labeling information to the database, regularly update it, and notify the FDA promptly if the information online is not correct. It also requires drug makers to provide a 24/7 phone number available to prescribers, which could provide information in cases of emergency.
This new rule has been in the works since 2012, when the Government Accountability Office (GAO), at the behest of legislators, began to investigate the advantages of doing away with a paper labeling system.
Their study, released in July of 2013, enumerated the many advantages of the project, but still voiced some concerns. Primarily, stakeholders worried that elderly patients might not be tech savvy enough to access the information and would much prefer a paper copy. Furthermore, many physicians prefer to use a paper copy when counseling their patients on their drug regimen.
With their proposed rule, the FDA addressed these concerns by stipulating that paper copies would still be distributed for patients and that the electronic database would be for use primarily by healthcare workers. Also, drugs could be exempt from the rule if compliance could pose problems to the drug’s safety or potency.
Ralph Neas, director of the Generic Pharmaceutical Association (GPhA), released a statement in support of the proposed rule. He said, “This streamlined 21st century approach to label information sharing could mark a significant step forward for everyone who relies on updated prescribing information for patients.”
The FDA will continue to take comments and suggestions for revisions to the rule for the next 90 days.