FDA FDA Enforcement of Criminal Liability for Clinical Investigator Fraud

Clinical investigator fraud is a very real problem, and falls squarely within FDA’s mandate to protect the public health.  The Eighth Circuit has held that under this mandate, FDA has the authority to impose affirmative duties to protect the public health by promulgating relevant regulations.  FDA did promulgate such regulations, and the Eighth Circuit held that a failure to follow these regulations is a violation of section 355(i) of the FDCA.  A violation of section 355(i) is considered a violation of section 331(e), and a violation of 331(e) can result in criminal sanctions under section 333(a).  Thus, this tenuous chain of statutes allows the government to bring criminal charges against fraudulent criminal investigators.

The Park Doctrine itself should also be utilized against clinical investigators.  Even if investigators are unaware of wrongdoing, they have the “responsible relationship” with the documents.  Also, currently clinical investigators are beholden to the sponsors, who ultimately sign their paychecks. If they are aware they will be liable, and subject to criminal penalties under the Park Doctrine, even when they are unaware of any problems, they will be more likely to seek out problems and report any wrongdoing they discover.