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Are GMP Violations The “Next Hot Thing” In False Claims Act Litigation?

This article was originally published in The Gold Sheet

Executive Summary

Former prosecutors say there are cases pending under seal, but it is uncertain whether the government will intervene. They note the difficulty in proving the allegations and say FDA’s regulatory regime may be a better route for handling GMP issues.

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Justice Targets ‘Serious’ GMP Issues, Hears More from Whistleblowers

The Justice Department is imposing harsh penalties on manufacturers that commit serious GMP violations and this trend will continue in the foreseeable future. DOJ is also getting more calls from FDA and whistleblowers alleging GMP violations under the False Claims Act.

GSK’s $750 Mil. DoJ Settlement: When GMP Violations Equal Healthcare Fraud

GlaxoSmithKline’s $750 million settlement with the Department of Justice raises a worrisome question for industry: will violations of current good manufacturing practices become a target for whistleblower suits?

Pregnant Women In Clinical Trials: Investigators Should Justify Exclusion, NIH Official Says

Enrollment-boosting strategy backed by industry rep at Duke-Margolis meeting as FDA official suggests having sponsors develop study plans for pregnant and lactating women with ‘elements of’ the requirement for pediatric studies.

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