Consumers are given a choice when purchasing pharmaceutical drugs. They can either purchase the more expensive advertised drug or the generic option. Take Lipitor for example; there are many generic options available. A generic medication has a similiar chemical structure, so why not? The decision may seem simple, but it is a lot more difficult than one might think.
Ranbaxy produces a generic form of Lipitor, and has a very storied past with the Food and Drug Administration that most consumers are completely unaware of. Yet, the actions of both parties could have a huge effect on the lives of many residents, including military veterans after the U.S. Department of Veterans Affairs signed a contract to buy the drug shortly before the maker pleaded guilty to selling adulterated drugs.
The history of the issues involving Ranbaxy began in 2008 when the FDA took its first action again the drugmaker by barring the company from importing 30 drugs that were produced in two different plants in India. At issue in this case was "the truth" of how the drugs were manufactured and under what standards. Thus, stricter regulations were put in place and new drug applications filed by Ranbaxy were put on hold.
Then, in November 2011 the FDA lifted the hold, allowing the company to offer a new drug to the U.S. population. In fact, the FDA granted exclusive first rights to sell the new drug. That drug was the generic version of Lipitor. The drug was sold for barely a year before 41 lots were recalled because glass particles had been found in the medication.
Despite the recall and the past issues, the FDA allowed continued sales but placed more restrictions on the company in January 2012. Now, over a year later, the drugmaker pleaded guilty in a whistleblower lawsuit. The charge was that the company knowingly sold adulterated drugs with the intent to commit consumer fraud, failed to report drugs that didn't meet requirements and made intentionally false statements to the U.S. government.
Source: CNN, "Maker of generic Lipitor pleads guilty to selling 'adulterated drugs,'" Katherine Eban, May 13, 2013
