Drug Good Manufacturing Practice Violations

Rate this item
(0 votes)

Many cases of alleged fraud involving drug manufacturing have been tried under the False Claims Act, a federal law passed by President Abraham Lincoln in 1863. Since its revision in 1986 the Act has been an especially valuable tool for US government prosecutors trying federal contractors accused of Good Manufacturing Practice Violations. The Act criminalizes contractors’ billing the government for unreasonable and unnecessary goods and services.

Government prosecutors are often assisted by whistleblowers who are current employees of Medicare, defense contractors and other accused parties. A whistleblower's insider knowledge of fraudulent practices may be pivotal to the prosecution’s case.

However, until recently the False Claims Act was rarely invoked in cases involving violations of Good Manufacturing Practice (GMP). This might be surprising given the government’s ever-increasing expenditures for pharmaceuticals under Medicare, Medicaid and military healthcare plans. On the other hand, the government has access to a variety of tools to restrain big pharma’s fraudulent activity. Without invoking GMP the government has successfully sued drug manufacturers, requiring them to pay heavy fines and relinquish their ill-gotten revenue. 

The first major victory involving the False Claims Act and a drug manufacturer was settled in October 2012. The defendant, GlaxoSmithKline, was accused of having failed to safeguard drugs at its Puerto Rican plant against contamination by microorganisms. Prosecutors also charged that manufacturing processes eliminated the effectiveness of some GlaxoSmithKline drugs. Thus, claims for payment were instances of Medicare fraud. GlaxoSmithKline pleaded guilty and agreed to pay $750 million in penalties.

Report Medicare Fraud and GMP Violations Here

Are you ready to join the whistleblowers? You may be rewarded financially for your efforts. Share your insider knowledge to help stop fraud and the wasting of public healthcare funds. Our attorneys specialize in representing whistleblowers for the healthcare industry. For a free consultation, contact our law offices via the form on this page or call  1-866-648-5223 .