“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.
More articles on pharmacy:
10 hospitals seeking pharmacy leadership
Patent protection clause is latest stumbling block for revised NAFTA
Dr. Reddy’s legal win expected to lower cost of opioid addiction treatment
At the Becker's 11th Annual IT + Revenue Cycle Conference: The Future of AI & Digital Health, taking place September 14–17 in Chicago, healthcare executives and digital leaders from across the country will come together to explore how AI, interoperability, cybersecurity, and revenue cycle innovation are transforming care delivery, strengthening financial performance, and driving the next era of digital health. Apply for complimentary registration now.