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US FDA's Sunscreen Progress Gets Dim Review From Congressional Appropriators

This article was originally published in The Pink Sheet & The Rose Sheet

Executive Summary

House and Senate appropriators' take note that US FDA has not approved an additional OTC sunscreen ingredient since the 2014 passage of the Sunscreen Innovation Act.

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Both bills allow 18-month market exclusivity periods for marketers of some products made available through additions or changes to OTC monograph, through which the majority of nonprescription drugs are made available in US. Senate bill in markup 31 October.

Octocrylene Now? Sunscreen Industry Under Growing Pressure As Environmental Concerns Mount

Lawmakers already are taking action to ban sales of oxybenzone- and octinoxate-containing sunscreens due to signals, however inconclusive, that the ingredients pose dangers to coral health. Now a new study suggests that octocrylene could be a concern as well.

House Passes US OTC Monograph Reform And Committee Clears HSA Change

Next step for OTC monograph reform legislation is Senate consideration; market exclusivity periods are likely focus of House/Senate conference. Separate bill to allow consumers to use health savings accounts to buy OTC drugs without a doctor's prescription clears House Ways and Means panel.

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