“We’ve seen a lot of instances of adulterated products — contamination, impurities — recently,” FDA Commissioner Scott Gottlieb, MD, told Bloomberg. “The underlying causes have been traced back to manufacturing, inadequate quality controls and generally poor management oversight.”
The FDA mainly relies on drug manufacturers to police themselves and issue voluntary recalls when an impurity is discovered.
The proposed rule changes, which may take several years to implement, will focus on ensuring the raw materials and active ingredients used to produce drugs are effective and safe. The agency plans to force drugmakers to do more rigorous testing of their materials before a product is sold to consumers. In addition, the agency plans to increase oversight and monitoring of drug manufacturing problems.
The increased safety regulation was prompted by more than a dozen drugmakers recalling different versions of generic blood pressure medications with potential carcinogens in the last eight months.
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