FDA Puts More Responsibility on Manufacturers

While “Buyer Beware” is a common philosophy, recent FDA recommendations would put responsibility for creating Patient Medication Instructions (PMI) squarely on the shoulders of pharmaceutical manufacturers. Janet Woodcock, chief of FDA’s drugs division appeared before the Senate Special Committee on Aging in December of 2013 testified that “information about a manufactured product is best produced and tested by that manufacturer.”  

Currently, PMI is created by the American Society of Health System Pharmacists (ASHP) or other drug information sources and is not reviewed by the FDA, but it is subject to its standards. Recent research by the FDA has indicated that PMI often fails to meet federal guidelines intended to make the information provided with prescriptions easier for patients to understand.

The FDA’s new proposal would make manufacturers be responsible for writing their own PMI. Some, including, Gerald K. McEvoy, ASHP’s assistant vice president of drug information, are concerned that allowing manufacturers to write their own PMI would result in inconsistent information quality or delayed updates.  

This proposal would replace the existing system with manufacturer authored information, expecting hundreds of varied companies to produce patient medication information without providing any central editorial oversight.

McEvoy has expressed concerns that the FDA’s proposal to allow manufacturers to develop their own PMI will result in inconsistent information for thousands of drug products, causing confusion for patients. With manufacturers left to their own devices there would be no way to assure consistent, relevant information would be provided across the board.    

For additional information, see the full text of the Senate Special Committee on Aging Hearing on Protecting Seniors from Medication Labeling Mistakes.

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