U.S. regulators and the public have focused enhanced scrutiny on the use and performance of diagnostics, with that scrutiny only sharpening during the COVID-19 pandemic. Recent enforcement trends have targeted diagnostics (whether approved, cleared, or authorized through an emergency use authorization (EUA)) and laboratories that perform testing and have focused not only on allegations of unlawful marketing but also on the tests’ accuracy.
The U.S. Food and Drug Administration (FDA) has long taken enforcement action against companies allegedly lacking approval, clearance, or authorization for tests purported to diagnose or assist with diagnosis of disease, particularly when there is a nexus with a high-profile public health situation. This trend has magnified during the COVID-19 pandemic with a plethora of warning letters focused on diagnostics that FDA alleges fail to meet required standards.
In addition, the agency has increasingly taken regulatory and enforcement actions against companies that have obtained appropriate marketing authorization but nonetheless face allegations related to a broad range of other issues, including test performance (i.e., false positives, false negatives, and/or false high or false low results) especially when there are allegations of patient injuries or death.
The Department of Justice (DOJ) also has brought actions against companies for allegations related to false or misleading labeling, defective products, and medically unnecessary laboratory tests. For diagnostics related to COVID-19, note that the U.S. Attorney General has developed a task force to help combat COVID-19 fraud. Similarly, FDA has made numerous statements regarding COVID-19 fraud and enforcement. We expect COVID-19-related enforcement and regulatory actions to continue to be a high-priority enforcement area.
Notable recent FDA and DOJ actions for COVID-19-related and broader diagnostic tests include
- a multimillion-dollar False Claims Act (FCA) settlement related to allegations that a diagnostic test contained a material defect that led to inaccurate results; according to the government, the company allegedly knew there was a problem based, in part, on postmarket complaints, but concealed the issue and did not take adequate corrective actions
- a million-dollar FCA settlement related to allegations that tests were performed without a valid physician order
- a multimillion-dollar FCA settlement related to allegations of unnecessary medical testing with diagnostic tests
- warning letters issued related to, among other things, alleged accuracy issues and failure to submit medical device reports or correction and removal reports related to allegations of false results
- FDA safety communications and requests for market action regarding diagnostic tests
Regulatory concerns about reliable tests are not new, but enforcement is increasing, and not just for diagnostics related to COVID-19. Companies should continue to monitor the enforcement environment and can take a number of steps to enhance patient protection and to minimize potential enforcement risk. Among other things, companies should carefully monitor and assess complaints and adverse events related to diagnostic tests. Companies should make sure that FDA reporting is timely and that prompt and adequate corrective actions are taken when needed. Additionally, the FDA and the DOJ closely review company websites and social media platforms for evidence of a product’s intended use; companies should regularly monitor these platforms for promotional material that could be construed as false or misleading. We anticipate additional FCA and Federal Food, Drug, and Cosmetic Act actions over the coming year.
1DOJ Press Release, Attorney General Announces Task Force to Combat COVID-19 Fraud, https://www.justice.gov/opa/pr/attorney-general-announces-task-force-combat-covid-19-fraud
2FDA Website, Beware of Fraudulent Coronavirus Tests, Vaccines and Treatments, https://www.fda.gov/consumers/consumer-updates/beware-fraudulent-coronavirus-tests-vaccines-and-treatments
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