Compliance Considerations For Pharma Co. Testing Programs

By Eve Brunts and Alison Fethke (June 7, 2021, 5:52 PM EDT) -- With the rise in precision medicine and increased awareness of rare and ultra-rare conditions, health care providers and patients are seeking more information to guide diagnosis and treatment decisions. Information about a patient's genetic markers or antibodies, obtained through diagnostic testing, can improve the accuracy of diagnoses and inform decisions about the potential effectiveness of drug treatment for particular patients.

Pharmaceutical companies are increasingly considering how they can appropriately assist patients in accessing such diagnostic tests. 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...

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