Last year a federal appeals court in Richmond, Virginia upheld the dismissal of a whistleblower suit alleging violations of current good manufacturing practices, known in the industry as “cGMP.” Filed under the federal False Claims Act, the whistleblower claimed that his former employer, Omnicare, violated a series of cGMP safety regulations requiring that penicillin and non-penicillin drugs be manufactured in complete isolation from one another. The regulations are designed to prevent cross contamination.
Because Omnicare’s drugs were not manufactured in isolation, the whistleblower claimed that they were not eligible for reimbursement under Medicare and Medicaid programs. A judge in Baltimore dismissed the suit saying that this particular alleged cGMP was not one that could be prosecuted privately by a whistleblower.
The case was appealed and ultimately upheld by a three judge appeals panel last year. (United States ex. rel Barry Rostholder vs. Omnicare) Is this the end for “filthy pharma” cases under cGMP and the False Claims Act? No!
The Justice Department and Food and Drug Administration (FDA) support whistleblower filings for cGMP violations. In the aftermath of the Omnicare decision, however, it is prudent to have more than a mere allegation that products were not manufactured in properly segregated facilities.
In April 2013, the Justice Department announced that it would be taking “an especially hard look” at cGMP violations. Jeffrey Steger, deputy director of the Justice Department’s consumer protection unit, said the agency’s priority was to “identify and prosecute the most serious instances of food, drug and medical device violations… and in general [protect] consumers from adulterated or misbranded products…”
Notwithstanding the big loss for whistleblowers in Omnicare, the court did not slam shut the door on all cGMP violations. The court appears to have left the door open for cGMP violations that are significant and substantial and give rise to actual discrepancies in the functioning of the product.
What does this mean in practical terms? Merely claiming that a drug wasn’t manufactured properly may no longer be enough. To qualify for a whistleblower award, one should show both bad practices and that the product is tainted, adulterated, mislabeled, diluted or contaminated.
People with inside knowledge of adulterated drugs and cGMP violations may qualify for cash awards under state and federal False Claims Acts. Last year the federal government alone paid out $635 million to whistleblowers. Under the federal law, companies can be assessed triple damages and fined up to $11,000 per violation. Whistleblowers can receive up to 30% of whatever the government collects. (The average award is closer to 20%.)