FDA Proposed Rule May Allow Quicker Safety Information for Generic Medications

14-Nov-13 9:00 AM  CST  

Generic drug product information may get updated faster than ever before if a proposed rule by the FDA becomes a reality.  The proposed rule would allow the makers of generic drugs to use the same exact updating procedures and take advantage of the same time frame branded drugs are updated.  If both the brand name and generic drugs were to be updated at the same time before the FDA has approved the label changes this would encourage quicker efforts towards patient safety and allow both the brand and generic drug makers to be on the same page about safety information updates.  In addition, the proposal also says generic drug makers would be able to independently update prescribing information and drug package inserts before the FDA would review the change.  Generic drug manufacturers would also have to inform legend drug makers of any label or product changes as well. 

            Janet Woodcock, M.D., and Director of the FDA’s Center for Drug Evaluation and Research recently commented on the proposal.  “This proposal will help ensure that healthcare professionals and consumers have access to the latest safety information for the medications they use.  More than 80 percent of prescriptions filled in the U.S. are for generics, so we want to make sure that generic drug companies actively participate with the FDA to ensure that product safety information is accurate and up to date,” said Woodcock. 

            Currently, the FDA is seeking public comment on the proposed rule in a federal register notice.  More articles concerning pharmacy and pharmacy technicians can be found by going to www.pharmacytechnician.org.               

1.  Walsh, Sandy.  “FDA Takes Action to Speed Safety Information Updates On Generic Drugs.”  FDA.  Web.  Date of Access:  13 Nov 2013. 

2.  DeArment, Alaric.  “FDA Rule Would Allow Faster Product Safety Information Updates for Generics.”  Drug Store News.  Web.  Date of Access:  13 Nov 2013. 

3.  Woodcock, Janet.  “Working to Improve the Communication of Important Drug Safety Information About Generic Drugs.”  FDA.  Web.  Date of Access:  13 Nov 2013. 

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Source: Jennifer O'Reilly

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