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What you can do if confined by compassionate use study rules

Pharma Compliance Alert, July 12, 2006

Managed markets teams cannot use the compassionate use program/regulatory regime for commercial purposes.

"A product cannot be marketed lawfully until approved and cannot be shipped in interstate commerce unless an exemption exists," says Mark Duval, a food, drug and device attorney at DuVal and Associates in Minneapolis. "The compassionate use program was designed to allow physicians to continue to treat patients in the study or find new patients for whom the product may work, but the physician would not have access to the product and the manufacturer could not ship it in interstate commerce, without the compassionate use exemption."

To involve medical science liaisons in what is essentially a commercialization of the compassionate use exemption is an end-run around the law and regulations, DuVal says. "This is an attempt to "seed" the market pre-launch to allow physicians to gain experience with the product pre-launch so the product hits the ground running post-launch. I would not permit it."

It is acceptable, however, for a company to let physicians know that a compassionate use program exists and they can help physicians who are in need of product. This should be done tactfully and should not approximate a pre-launch advertising program, DuVal says.

DuVal joined MSL director Ann Harris and fellow attorney Bruce Armon for an audioconference last month. For details on how to access this, click here.

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