Big pharmaceutical companies have been caught committing substantial fraud on the taxpayers to the tune of hundreds of millions of dollars and the government is paying significant whistleblower rewards for reporting these kinds of frauds by pharma drug companies.
“The pharmaceutical industry appears to continue to defraud the government by marketing drugs for purposes that the FDA has not approved, for paying kickbacks to physicians for selling drugs and for over-pricing their products.”
Off Label Drug Promotion
The FDA approves a drug for sale for a particular purpose or disease. When a pharmaceutical company promotes a drug or product for unapproved uses to doctors, this is clear fraud.
Kickbacks paid by pharmaceutical companies to doctors, hospitals, pharmacies, nursing homes or other healthcare providers are illegal.
RANBAXY INDIAN GENERIC DRUG MAKER AND PHARMACEUTICAL FRAUD ON AMERICA AND ONE WHISTLEBLOWER’S COURAGE
Jeffrey A. Newman Esq.
Eighty percent of all generic drugs taken in the United States are manufactured in a factory within a foreign nation and the market within our country for generic drugs exceeds $242 billion and is increasing each year. Ranbaxy, a generic drug manufacturer based in India was the first to sell drugs in the U.S. and is now the sixth largest generic drug maker in the country with more than $1 billion in sales here in 2012. Recently however, Ranbaxy pleaded guilty to seven federal criminal counts of making intentionally false statements to the FDA and agreed to pay $500 million in fines. Despite the clear criminal wrongdoing, none of the company executives face criminal penalties. The Ranbaxy back story is a sordid tale but it is also indicative of significant problems that the U.S. is facing in knowing the quality of the drugs in our stream of commerce and the difficulties in checking on drug manufacturing facilities abroad. To date most of the procedures are reliant on self reporting and simply assume the truthfulness of the information submitted—the honor system. Obviously in the case of Ranbaxy, the information was untrue and the drugs sold here adulterated and tainted.
The last report from the Government Accountability Office concerning foreign made drugs was issued in 2009 and it revealed that regulators inspect only 11% of foreign drug manufacturing plants. 40% of the domestic plants are inspected.
The incredible fraud by Ranbaxy executives was first revealed to our government by a whistleblower working at the company, Dinesh Thakur. Thakur was the director of research information and project management. Back in 2004, he observed several irregularities in Ranbaxy’s drug applications including lying to regulators and forging documents. The company produced data suggesting that its processes were clean and working but that data was constructed and false. Company scientists told Thakur that they were directed to substitute cheaper, lower-quality ingredients in place of better ingredients to obtain certain results on tests. Often the data was just made up. For its HIV drugs, Ranbaxy was using ingredients that had failed purity tests.
Thakur and his boss tried to convince management within the company to change things and to cleans its operation and reveal the wrongdoing voluntarily to regulatory authorities. The company would not do so and finally he revealed the wrongdoing to the FDA. At one point during this period, Ranbaxy produced a generic form of Lipitor which it sold heavily in this country and it was found to contain glass particles. Those pills had been produced in the same Indian labs where the data was fabricated and reports altered.
While the $500 million settlement was high, it is not a lot of money for a company earning more than $1 billion a year from U.S. sales. It is unclear as to whether the FDA is able to regulate and control the drugs manufactured in other nations. This is an issue which Congress is presently examining. The fact that a whistleblower had to come forward to reveal the extensive fraud which was ongoing for years is an indicator that this is just a tip of the iceberg. Jeffrey Newman represents whistleblowers.
WHISTLEBLOWER PHARMACEUTICAL CLAIM AGAINST POLYMEDICA HANDLED BY ATTORNEY NEWMAN $35 MILLION SETTLEMENT –Diabetes Drug distributed without Doctors orders Jeffrey Newman represented a New Hampshire resident who was sent medicines by mail by medical product companies Liberty Medical Supply and Liberty Home Pharmacy, without permission or authorization from her doctor. A whistleblower claim was filed by Attorney Newman in the name of the United States Government under the False Claims Act (FCA).Those companies and their parent, Polymedica, a Woburn Massachusetts based company, agreed to pay the United States $35 million to resolve the allegations that they submitted claims to Medicare without proper documentation for diabetic and nebulizer products. The Liberty companies, based in Port St. Lucie Florida, violated the FCA by not obtaining a signed doctor’s order or prescription for the products and without first obtaining and maintaining documentation verifying the necessity of treatment volumes in excess of administrative guidelines.Under the terms of the settlement, Polymedica Corporation and its subsidiaries agreed to comply with a corporate integrity agreement with the Office of the Inspector General. The case was filed by Attorney Newman in the Federal Court in Boston.