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In Law360, Health Care Attorneys Examine Compliance Considerations for Pharmaceutical Testing Programs

Practices: Health Care, Life Sciences, Biomedical Research: Human, Animal and Bench Science, Digital Health, FDA Regulatory, Litigation, Government Enforcement / White Collar Criminal Defense

In a Law360 article, health care partner Eve Brunts (Boston) and health care counsel Alison Fethke (Chicago) discuss how pharmaceutical company-sponsored testing programs can provide real benefit to patients, but should be carefully considered in light of possible fraud and abuse and other regulatory risks. 

The authors explain that pharmaceutical companies are increasingly considering how they can appropriately assist patients in accessing diagnostic tests that may help inform clinical decisions about appropriate drug therapy. Such assistance may include offering or supporting free testing programs.

The programs may, however, raise potential compliance considerations, including fraud and abuse, U.S. Food and Drug Administration promotional and patient privacy concerns. As a result, testing programs offered or supported by pharmaceutical companies should be carefully structured to address these considerations and mitigate potential risks.

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