Stories of corruption that have been coming out of the Food and Drug Administration in recent years highlight the need for FDA whistleblowers. Drug and pharmaceutical companies seek FDA approval by the hundreds each year. Unfortunately there have been many instances when drugs that were later proven to be unsafe, were approved by the FDA in part because of the fraudulent nature of the reports and data submitted by the drug companies. It is therefore extremely important when an employee within the drug companies notices something amiss and reports it. This is what being an FDA whistleblower is all about.
One of the most prominent cases that have been in the news is concerning the drug company Ranbaxy. Dinesh Thakur, hired by Ranbaxy in 2003 would later blow the whistle on the fraud and criminal activity within the company. Essentially, Thakur found that Ranbaxy had a history of submitting untrue and misleading data to the FDA while seeking approval for their generic drugs. Thakur reported his findings to the FDA and in May of 2013 Ranbaxy pleaded guilty to seven felonies and agreed to pay criminal fines and forfeiture in the amount of $500 million. Dinesh Thakur was awarded $49 million in a U.S. court for exposing the company as FDA whistleblower.
The decision to become an FDA whistleblower could not have been an easy one. In fact, when asked what someone else in his position should do if they are seeing things that are wrong, Thakur said, “They should follow their conscience. They should follow their conscience and do what it says that they ought to do.”
FDA Whistleblower Hotline
Employees and executives currently working in any of the drug or medical companies seeking approval through the FDA are potential FDA whistleblowers. Should you see anything illegal or unethical taking place within your company, or if you come upon information to that effect, the best place to report it within the FDA is the FDA Office of Criminal Investigation.
The FDA is a large and powerful federal regulatory body. It proudly claims to regulate 25 cents of every dollar spent by American every year. An organization of such scope is certain to experience fraud. The FDA website lists 14 areas of potential fraud investigated by its OCI division; everything from new drug application fraud to manufacture and distribution of counterfeit or unapproved drugs.
Corruption in the FDA
Not only are their drug companies perpetrating fraud, but there are even examples of fraud within the FDA itself. In some cases, FDA inspectors and executives are pressured by the desire to keep the big companies happy and as a result there is a need for employees and executives within the FDA itself should be on the lookout for illicit or unethical conduct.
As with any decision to be a whistleblower, it is wise to keep excellent record with names and dates if possible. Drug companies do not look kindly on FDA whistleblowers so having your case solidly built and researched will go a long way toward protecting yourself from retaliation.