Could Sponsors’ Supply Chain Policing Have Caught Alleged CRO Fraud?

 
• By Derrick Gingery
  
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The US FDA always encourages sponsors to ensure their suppliers and contractors are following the law, but agency inspectors may have been the only ones who could have discovered the data integrity problems that forced the downgrading of more than 100 generic drug applications.

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Sponsors are expected to police their supply chains, but their authorities do not match those of FDA inspectors. • Source: Alamy

Sponsors should be highly motivated to avoid the type of clinical trial fraud that caused the US Food and Drug Administration to downgrade the bioequivalence rating of more than 100 products. But the emergence of another high-profile data integrity problem may once again raise questions about the security and oversight of the generic drug supply chain and the industry role in its stewardship.

FDA officials have long told generic and brand drug officials that they must be vigilant that the suppliers and contractors...

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