In­dus­try groups warn of drug short­ages linked to wide­spread car­cino­gen test­ing as FDA dou­bles down on its ap­proach

With the re­cent and un­ex­pect­ed dis­cov­ery of prob­a­ble hu­man car­cino­gen im­pu­ri­ties prompt­ing re­calls of pop­u­lar heart­burn drugs like Zan­tac and niza­ti­dine, as well as met­formin di­a­betes med­i­cines, ARBs and more, the FDA has made clear the need for an in­dus­try-wide risk as­sess­ment for the so-called ni­trosamines in even more drugs that may be at risk.

But in­dus­try groups are push­ing back on the need for such wide­spread test­ing, ar­gu­ing that the FDA should be more con­sis­tent and col­lab­o­ra­tive with oth­er reg­u­la­tors in its ap­proach, and that the time­lines for such test­ing are too con­strict­ed and may lead to se­ri­ous drug short­ages.

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