Regulatory Inspections and Enforcement Actions Are Limited

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This is a copy from :

Pharmaceutical Outsourcing | 40 | April/May/June 2020

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Chris HarveyDirector of Recalls Stericycle Expert Solutions

Current oversight activities are significantly limited. This is in part a result of the significant decrease in on-site inspections and the limitations of paper-based audits. Add to that the impact of enforcement discretion and emergency authorizations.

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As regulators and the entire healthcare industry – from pharmaceutical and medical device manufacturers to frontline medical professionals – take an all-hands-on-deck approach to pandemic response, other activities are being delayed if they even happen at all.

For example, the FDA may give more consideration to the risk-benefit analysis in the immediate short term, and temporary permissions are being granted for why and how drugs and devices can be used.

These activities are being conducted in good faith by all parties during a global crisis, but the FDA maintains the right to reverse course later once the enforcement discretion and emergency authorizations are lifted – likely by publicly demanding more detailed information about your product.Add to that the recent publicity from Bloomberg Law that the FDA is allowing overseas pharmaceutical plants “with checkered safety and quality records” to make medicine for

American consumers. Some of the agency’s first stops during an on-site inspection tour could be these overseas manufacturers who have a history of violations but have stepped in to prevent or lessen product shortages. In some cases, these companies may be the API manufacturers that were under scrutiny before this outbreak started.

So until FDA inspectors can get back on the road, we may see a slight dip in recalls and other enforcement activity. But keep in mind that could change once regulatory staff start catching up with the backlog of inspections and have more time to proactively inquire about products that may have been granted permission for new or different uses under emergency authorizations.

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