In the past, the Food and Drug Administration (FDA) took the lead role in investigating pharmaceutical manufacturing facilities for violations of good manufacturing practices (cGMP’s). Recently, the Department of Justice (DOJ) became a more actively involved in enforcement actions against pharmaceutical manufacturing facilities due to whistleblowers. The DOJ investigates all Qui Tam (whistleblower) lawsuits filed under the False Claims Act.
Enforcement efforts by the FDA and DOJ target pharmaceutical companies that are not following good manufacturing practices to satisfy safety, quality, and purity requirements for prescription drugs.
In two recent cases, facilities had numerous, egregious problems that were exposed by whistleblowers. In one case, two prescription drugs were contaminated with microorganisms. In another case, a pharmaceutical company knew that certain batches of a drug tested positive for “unknown impurities” and had an unreliable shelf life, but sold the drug for patient use anyway.
Whistleblowers have altered marketing practices within the pharmaceutical industry through hundreds of Qui Tam cases brought under the False Claims Act alleging widespread “off-label” sales practices. Those cases have helped to slow down marketing of prescription drugs for dangerous, unapproved uses, and have cost the pharmaceutical industry millions of dollars in fines.
The False Claims Act and whistleblowers could prove to be just as effective to help clean up pharmaceutical manufacturing facilities.
Evans Law Firm, Inc. handles Qui Tan (whistleblower/false claims), consumer fraud class actions, insurance and banking fraud, consumer product liability, elder abuse, and personal injury cases. If you think that you have witnessed or are the victim of financial fraud by an insurance company, bank or individual then, contact Evans Law Firm, Inc. at 415-441-8669 for a free and confidential consultation, or email firstname.lastname@example.org