Earlier this month, Customed, Inc. initiated the largest medical device recall ever recorded in FDA history.  The recall was of sterile convenience surgical packs and was due to packaging flaws.  These flaws could result in loss of sterility and lead to infection.  There have also been a number of voluntary recalls on the drug side related to sterility.  FDA has also issued warning letters to pharmaceutical companies for poor aseptic practices, among other Good Manufacturing Practices (cGMP) related issues.  These headlines should remind the medical device and pharmaceutical industry of the importance of sterility and the renewed focus the government has with respect to these issues.

How does a company decide what aspects of sterility to focus on to ensure their processes are aligned with FDA’s current thinking?

  • Constantly Review Recent Warning Letters:  This can give you a road map as to what FDA is looking into when conducting an inspection.  Determine the issues other companies faced and ensure your systems address these issues.
  • Be Aware of Recent Recalls:  Ensure that your company understands the reasoning behind the recalls and if similarities exist between your processes/products and the company that is initiating the recall, assess whether changes need to be made within your organization.
  • Be aware of the most recent FDA Guidance Documents
  • Be aware of the most up-to-date ISO standards

It is important to note that violations of sterility may not only expose companies to potential liability under the FD&C Act, but also has the potential to lead to allegations that violations of the FD&C Act caused false claims to be submitted in violation of the False Claims Act (FCA).  Historically, manufacturer’s exposure under the FCA was based on allegations of off-label promotion or alleged anti-kickback violations.  However, in 2010 that changed when GMP violations served as one of the basis of liability in the GlaxoSmithKline $600 million settlement.  This month, a complaint was filed against Gilead Sciences, Inc. alleging the company’s failure to comply with the FD&C Act resulted in FCA violations.  Specifically, the complaint alleges that the company caused the submission of false claims by selling products that lacked potency and were contaminated with filth, metal and microbes.  At the same time, a recent court case has called into question the extent to which GMP violations can cause a claim to be false or fraudulent.

Given these actions, pharmaceutical and medical device manufacturers should pay close attention to the possibility of not only being subject to heightened FDA enforcement, but also possibly having to defend themselves against allegations under the FCA.