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False or misleading reports to FDA could mean jail time

This article was originally published in The Silver Sheet

Executive Summary

Device and drug company executives could go to prison if a submission to FDA is discovered to be false or misleading, under a bill introduced in the Senate July 31. The Drug and Device Accountability Act (S.3409), sponsored by Sens. Ted Kennedy, D-Mass., and Chuck Grassley, R-Iowa, is intended as a companion bill to the FDA Globalization Act, proposed legislation that aims to strengthen FDA's oversight of imported products ("The Silver Sheet" May 2008). The Accountability Act contains several new provisions that would make manufacturers more vulnerable to legal and government actions. One of those provisions, "certification of information," would require a senior official from a device or drug firm to certify in writing that the information in a submission to FDA - including all adverse event and other post-market reports, as well as pre-market submissions and supplements - is "not false and misleading." If information does prove false or misleading, the company would be liable for $1 million to $5 million in penalties, depending on whether the action was considered "willful." The certifier would be liable for the same fines, plus a possible 10 to 20 years in prison
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