FDA’s current engagement with the GMP compliance problems in the generic injectable arena illustrates the tightrope the agency is walking in trying to protect patients against substandard, high-risk products, while at the same time trying to assure that they have access to the critical medicines they need.
Complicating FDA’s decision making is that a specific course of action taken with a noncompliant manufacturer may address one or both concerns today, but end up exacerbating the problems later down the road.
Raising the stakes further is the high-risk nature of injectable manufacturing in which quality problems are not easily detectable and traceable but can have very serious health consequences.
In an insightful white paper published in the February issue of Clinical Pharmacology & Therapeutics, Center for Drug Evaluation and Research Director Janet Woodcock and CDER colleague Marta Wosinska highlighted the complexities the agency faces in choosing a course of compliance action when shortages of critical drugs are at risk.
“The FDA’s need to use regulatory flexibility on behalf of patients to avert and mitigate shortages could have unintended long-term consequences when coupled with the market’s lack of reward for quality,” the paper notes.
Regulatory action can result in the immediate prevention of adverse health consequences and also “the long-term incentives for firms to keep all of their facilities and processing lines up to quality standards.” Conversely, the awareness that the agency will not be aggressive due to drug shortage concerns, incents firms to “push the envelope” on quality and forestalls investments that would result in a more predictable drug supply later.
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