Filthy Pharma: Justice Department Taking "Especially Hard Look" At Manufacturing Plants
The pharmaceutical industry has a lot of dirty laundry. Now to help clean up pharma manufacturing facilities both in the US and abroad, the US Department of Justice is promising to take an “especially hard look” at plants to ensure the safety and purity of prescription drugs.
Increased Justice Department scrutiny represents a shift from past government enforcement approaches where the US Food & Drug Administration took the lead initiating investigations of pharma manufacturing plants for violations of good manufacturing practices (cGMPs).
While the FDA continues to have a key role, whistleblowers using the False Claims Act have opened the door for the DOJ’s more active involvement in enforcement against the dirtiest offenders. The Justice Department investigates all “qui tam” (whistleblower) lawsuits filed under the False Claims Act, including those that allege Medicare and other government healthcare programs were defrauded by paying for adulterated medications.