Pharma Whistle Blower Blog

After U.S. Food and Drug Administration (FDA) inspectors noticed missing quality test results during a March 2015 visit to China’s Taizhou-based Zhejiang Hisun Pharmaceutical Company, the FDA announced on September 9 its decision to ban 15 products from export to the U.S. over concerns of...

As of August 2015, India’s generic pharma manufacturer Wockhardt Ltd. has ordered a total of 35 recalls of approximately 20 different drugs as part of a remediation plan in response to concerns arising from a 2013 inspection by the United States Food and Drug Administration (USFDA). Recalls...

The U.S. Department of Justice announced that it has settled allegations against a Stockton, California oncologist for dispensing counterfeit and unapproved chemo drugs to his patients. Under the terms of the deal, Dr. Neelesh Bangalore will pay the government $736,000. As part of the deal, Dr. Bangalore was not required to admit any wrongdoing.

The Justice Department accused Dr. Bangalore of dispensing Altuzan, a chemotherapy drug, to his patients. The drug was allegedly imported into the U.S. by Warwick Healthcare Solutions Inc. (Richards Pharma). Warwick is not licensed by the FDA.

Unapproved AND Counterfeit Altuzan with no API

Worse than the licensing problems, Altuzan is not FDA approved. Although apparently approved for use in Turkey, it is not distributed in the U.S. The FDA claims it tested the drug dispensed by Bangalore and determined it was counterfeit and contained no API....

The Drugs Controller General of India (DCGI) has recently decreed the Government will conduct a massive review of 42,000 Indian-made Pharmaceutical products, as DCGI leader NG Singh declares India will "tell the world that our drugs are of quality."
However, the Indian Central Drugs and...

India’s leader in US-bound generic pharmaceuticals, Dr. Reddy’s Laboratories, is now facing several large product recalls due to significant deviations in potency of active pharmaceutical ingredients. FDA issued an Enforcement Report on May 6, 2015 announcing the recall of divalproex...

Today, the India Government Department of Pharmaceuticals released a report compiled in May 2015, entitled “Recommendations of the Task Force on Enabling Private Sector to Lead the Growth of the Pharmaceutical Industry.”
The sparse Regulatory Enforcement observations related that...

There was an interesting article in Forbes this week concerning the CEO salaries of Big Pharma and other healthcare giants. According to the article, "There is no mistaking the fact that the sector with the highest market capitalization – pharmaceutical companies – also had the highest executive compensation. This sector also had the highest net profit margins (NPMs) of any healthcare sector and it could well be the highest NPMs for any industry including those outside of healthcare."

We aren't surprised.

DOJ Says Healthcare Fraud Costs Taxpayers Billions: Federal False Claims Act Statistics

Unfortunately, the healthcare industry also has the highest rates of fraud according to Justice Department statistics compiled under the U.S. Federal False Claims Act. Medicare fraud costs taxpayers billions of dollars every year. Is there a tie between huge executive salaries and greed? Absolutely....

One of the worst tragedies from adulterated pharmaceutical drugs in the United State was the contaminated Heparin imported from China and distributed by Baxter International. We have covered that story elsewhere on our site in the hope that such a pharma disaster never occurs again. And, yet we...

The FDA discusses bad pharma in terms of warning letters and highly technical regulations. Companies are fined, promises are made and unfortunately, within a few months it is often back to business as usual.
There is another side of adulterated drugs, however, a story complete with names and...

Other Non-U.S. Citizens Eligible Too: Recent $30 Million Award Last year the United States Department of Justice paid out over $635,000,000.00 (US) in whistleblower awards. The various 50 states, the U.S. Securities and Exchange Commission (SEC) and the U.S. Internal Revenue Service (IRS) paid out...