The comment come just weeks after Ranbaxy USA paid a $500m settlement and pleaded guilty to manufacturing and releasing batches of adulterated drugs following an investigation prompted by former Director of Project & Information Management at Ranbaxy, Dinesh Thakur, who notified US authorities of various manufacturing deficiencies after reports to management received no response.
But people like Thakur are in the minority according to Scott Wilson from National Advocacy Group America’s Watchdog who told in-Pharmatechnologist.com employees are scared off as pharmaceutical firms “will frequently fire people like this on the spot.”
He explained pharma employees that do report their firm to regulators risk being “blackballed by the industry, and it is unlikely they will ever get a job with big pharma, or a medical device company again.”
Such exclusion explains why financial rewards for successful whistleblowers are so large, Wilson said. However, for reporting manufacturing violations such settlements are typically less easy to attain “because it becomes much more difficult to prove if the drugs were tainted” by any misconduct.
One example he cited was a company Wilson dealt with - though was unable to disclose - who had the whistle blown due to the presence of cockroaches on the plant floor.
Such issues with cGMP are controlled by regulatory bodies like the US Food and Drug Administration (FDA), which told in-Pharmatechnologist.com what role whistleblowers play in ‘policing’ the drug industry.
“FDA regularly receives information indicating a regulatory issue or improper conduct,” said Stephen King, Public Affairs Specialist at the FDA’s Center for Drug Evaluation and Research.
“The agency typically investigates allegations through onsite inspection or other means. In the past such investigations have revealed significant public health issues and led to significant regulatory actions.”
Furthermore: “The agency generally attempts to keep information from informants confidential provided that there is no legal disclosure obligation.”
With the Ranbaxy case, the Department of Justice reported the FDA had inspected the company’s Dewas, India facility in 2006 and 2008 and found significant deviations in the manufacture of certain APIs and finished products as well incomplete records and an inadequate stability programme.
The FDA also sent warning letters and issued a consent decree against GlaxoSmithKline’s Cidra, Puerto Rico facility after poor manufacturing practices were uncovered by former employee Cheryl Eckard. The company eventually had to pay a $750m to settle the lawsuit.
Speaking at the time, GSK issued a statement regarding whistleblowers, rejecting the idea it engages in retaliation against employees who highlight quality control: “Employees are encouraged to report any concerns they might have to management or through a confidentiality compliance hotline.”
Regarding the blackballing of whistleblowers in the industry as a whole, in-Pharmatechnologist.com asked the Pharmaceutical Research and Manufacturers of America (PhRMA) - the trade group representing pharmaceutical companies in the US – for its views but the organisation told us it “doesn’t have a position to share.”