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OTC DFL ‘Remains Static, Non-Customizable Tool’ As US FDA Lifts Curtain On Potential Changes

 
• By Malcolm Spicer

Webinar on DFL requirements was a good launch toward potential changes, says CDER Office of Nonprescription Drugs Director Theresa Michele, "This is a great opportunity for us. I think we are on the cusp of a lot of neat things in the OTC marketplace."

In an FDA webinar slide, California State University, Sacramento, marketing researcher Jesse Catlin captured the consensus about OTC DFLs required by the agency. • Source: Jesse Catlin/FDA webinar

Drug Facts labels required for OTC drugs available in the US have been a success but leave a lot of room for improvement, according to a consensus of Food and Drug Administration officials and drug labeling experts.

“Having been in the marketplace for 20 years, the remarkable safety profile of OTC drugs using the DFL format I think it speaks for itself,” said Jesse Catlin, a California State University,

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