Something is holding up FDA's guidances on the reporting of adverse events for OTC drugs and dietary supplement products. As a result, the agency has extended the deadline for compiance with the labeling requirements of the 2006 adverse event reporting law another year, to January 2010.
The Tan Sheet looks into what's behind the delay:
AER Label Compliance Extended Until 2010 For OTCs, Supplements
FDA is extending the deadline for adverse event labeling requirements for OTC drugs and dietary supplements until January 2010 because it has yet to finalize its guidance to comply with those regulations.
In separate notices prepared for the Dec. 9 Federal Register, FDA notes the only change from previous draft guidances is the extended compliance date for labels.
The current draft retains language that industry stakeholders have objected to - a requirement that OTC and supplement labels include the manufacturer's full address or phone number and a statement informing consumers that the information is for reporting adverse events associated with use of the product.
With the guidances not yet finalized, it is possible that language will not survive to the final versions.
"FDA is committed to conducting a proper and thorough review before finalizing the guidance document. Given the wide range of issues FDA is working on we will need extra time to accomplish this," the Center for Food Safety and Applied Nutrition said in an e-mail.
In response to drafts FDA issued in December 2007, trade associations objected to the full address requirement. They say it went against Congress' intent in the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006, which made AERs mandatory for those products.
They also said no other FDA-regulated products are required to have a full address on labels or an introductory statement.
Further, firms and trade groups told FDA they would incur significant costs for changing product labels.
Under the AER law, OTC drug and supplement firms this year began compiling AE information reported by consumers or their representatives and submitting the reports to FDA.
In September, FDA revised its estimate for annual mandatory AERs related to supplement products to 856 from 960, based on the 214 AERs it received between Jan. 1 and April 15. The agency maintained its estimate for annual serious OTC AERs at 12,500 from approximately 50 respondents.
- Malcolm Spicer (m.spicer@elsevier.com)
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