WAHSINGTON As the Food and Drug Administration prepares its response to the question from Sen. Sherrod Brown, D-Ohio, on how best to hold drugmakers accountable for drug quality, the Center for Drug Evaluation and Research’s Office of Compliance is highlighting the agency’s efforts to examine the drug supply chain, reiterating regulations that the New Drug Application holder is responsible.
“Ultimately the dosage form manufacturer with its name on the label is responsible,” the Office of Compliance said. “Our regulatory structure under the [Food, Drug and Cosmetic] Act, and implementing regulations, provide for the identity, strength, quality and purity of the drug and the prohibited acts provide for civil sanctions and criminal penalties for failure to do so.”
The office commented on the best way to hold firms accountable for drug quality incidents, such as the heparin contamination, in which the manufacturer complies with FDA regulations—passing inspections and conducting U.S. Pharmacopeia tests on incoming products—but unknowingly distributes adulterated drugs anyway.
“In light of the question on how to deal with incidents such as heparin, sourcing ingredients, testing and [control of the] supply stream … are important elements FDA and other regulators are examining and encouraging industry to focus on to prevent such incidents,” the Office of Compliance said.