Pharma Whistle Blower Blog

An analysis by the consumer advocacy group Public Citizen says that big Pharma is paying less in fines. Has the industry cleaned up? Has there been a change in political thinking? Or is the FDA and Justice Department busy doing other things?
To answer that question, lets look at the numbers...

Joel Joseph is an activist. He is the chairman and founder of the Made in the USA Foundation, a non-profit that promotes American made products. Normally he helps American companies compete against cheaper, foreign made goods. In 2014, he found himself the unwitting purchaser of foreign made...

Swiss and Israel prescription drug authorities have reported today that one of the world’s biggest drug breakthroughs in defeating chronic Hepatitis C, is now being illegally imported from India as a fake pharmaceutical product. In late 2014, Gilead Sciences launched HARVONI in the US and...

Bribery and corruption is a way of life in many countries. It is how business is done. Sadly, there are areas of the United States where corruption still thrives. It also illegal. One of the biggest weapons against foreign bribery is the FCPA, the Foreign Corrupt Practices Act.
The FCPA makes...

Sun Pharmaceutical Industries Ltd. of India, the world’s fifth largest generic prescription drug maker, was slammed by the US FDA with an extensive Warning Letter on December 17, 2015, after unsuccessfully trying to work through the devastation caused by an earlier strong FDA Warning Letter...

United States Justice Department officials and regulators have settled Medicaid fraud charges against Vintage Pharmaceuticals (doing business as Qualitest Pharmaceuticals), its parent Endo Pharmaceuticals and several other affiliates. All of the charges relate to fluoride supplements sold by...

Pharma manufacturing cGMP has lately become an unbelievable drumbeat of Enforcement Reports and FDA and EMA Import Bans, even repeatedly, at several generic manufacturers.
But is non-compliance convulsing so much in the ground beneath our industry that we now have the “Big Pharma...

Rarely do we express disappointment with the FDA. They do an extraordinary job keeping us safe. We never waivered in our support for the FDA in 2007 when Congress (and the public) blamed the agency for the deaths of 149 Americans who received adulterated heparin.
Americans receive billions of...

Available only with a physician’s prescription, epinephrine is used for the emergency treatment of life-threatening allergic reactions (anaphylaxis). It is available either in injectable form (solution in a vial) or already packaged in an injector. Common U.S. brand names include Adrenaclick,...

The U.S. Food and Drug Administration is charged with insuring that the drugs we take are safe and come with appropriate warnings. A recent trial shed light on how big pharma sometimes attempts to tamper with regulators.
Documents revealed in a recent trial suggest that McNeil Consumer...