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GAO Report Casts Shade On Sunscreen Ingredients' Chances With FDA

 
• By Malcolm Spicer

Report to key US legislators could boost efforts to revamp approaches to making nonprescription ingredients available.

FDA and sunscreen active ingredient sponsors appear at a standstill on using time and extent applications (TEAs) to add ingredients to the OTC monograph, the General Accountability Office says in a report to Congress. Increased FDA resources alone aren't the sole solution to the problem, because sponsors are so far reluctant to invest in studies needed to support TEAs.

An alternative route, the new drug application process, is no more likely to attract sponsors, especially given the relatively fast...

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