Industry groups warn of drug shortages linked to widespread carcinogen testing as FDA doubles down on its approach
20 Jul 2021
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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