Essay About Internal Documents And Cheaper Generics

Purdue – Oxycontin
Purdue – OxyContin
Facts
I. Experiencing (Awareness of Data)
1.) OxyContin was introduced the U.S. in 1939. In 1996, it was approved by Health Canada. It is a opioid medication that has been regarded as a wonder drug because of the powerful, long-acting pain relief it provides in adults (Diebel). It has been the companys biggest “money-maker” (Diebel). Since then other drug makers like TEVA Pharmaceutical Industries, Impax Laboratories, Mallinckrodt, and Covidien have been trying to get a piece of the 2.8 billion-market share (Palmer). Additionally, the original patent expired April 16, 2013. The Center for Disease Control and Prevention has statistics that show that “overdoses of painkillers cause more deaths in 2010 than heroin and cocaine combined. In addition, it also became known as a “hillbilly heroine” because of the abuse that was occurring in poor rural regions (Diebel). Then in 2010, after spending 100 million dollars, Purdue Pharma, came out with a new version of OxyContin. This time around, the pill is harder to abuse because they made the pill harder to crush, or “heat for injection (Stanton). As a result, this has extended the patent until 2025. However, the issue the company is facing right now is regarding whether to allow cheaper generics into the equation. Some doctors believe that restricting generics is not going to solve any problem while others such as the government believe that “drug abuse is often tied to many other crimes life theft” therefore, strict enforcement is required. A representative of the Purdue stated “we believe that no generics to OxyContin should be approved that are not formulated to be abuse-deterrent (Stanton). The problem is that why should the FDA restrict generics from entering the market if Purdue has not given legitimate data that shows that the new version of OxyContin does in fact deter abuse. The company has its own research that shows dropped numbers but Purdue Pharma has proven in the past that it cannot be trusted. (Business Law by Roger Leroy Miller)—> For example, when OxyContin was first marketed it was described to be “unlikely to lead to drug addiction or abuse.” (85) However, later internal documents showed that the companys executives knew that OxyContin “could be addictive, but kept this risk a secret to boost sales and maximize short-term profits. This is proven when in 2007, 3 executive plead guilty to criminal charges involving misled patients, regulators, and physicians about the risks of addiction. Purdue obviously had the “intent to defraud or mislead” (Meier). It is also very suspicious how Purdue Pharma, launched its new version of OxyContin nine months before the expiration of the original patent (Diebel). Randy Steffan, vice-president of corporate affairs, has said