Tuesday, April 16, 2013

Feeling the Pain of Generic OxyContin


 
 So this happened:


   


The more I read about the FDA, the more I realize how similar it is to the Supreme Court of the United States. A select group of unelected individuals make sweeping decisions that affect the lives of millions of people, and can literally destroy companies. Or, in the case of Purdue Pharma, boost their stock considerably in a tough market.

Like in the Martha Stewart case, the New York Stock Exchange has been anxiously waiting for the FDA's verdict on a drug in recent weeks. In the last few years, OxyContin (a painkiller) has been reformulated to make it more difficult to crush and therefore more difficult to abuse. This "new" version of OxyContin has been approved, but several drug companies lined up to produce versions of the "old" OxyContin. FDA officials decided not to approve generic OxyContin, explaining that they are unnecessarily risky (even though, until recently, the FDA-approved version of OxyContin was virtually identical to these generic versions).

Let's talk brass tacks. The FDA's refusal to approve drugs that until a short while ago were perfectly legal has resulted in a windfall for the OxyContin company, and will damage the companies that were simply producing a legal, FDA-approved drug.

Is the FDA being protective or hypocritical? No matter how you look at it, this is another example of the FDA's far-reaching impact in our economy as well as our health. As the Wall Street Journal put it,
 
"The FDA's ruling, stating that original OxyContin was removed for "reasons of safety or effectiveness," means that generic versions of the drug can't come to market. The decision was applauded by some proponents of the new technologies. "This could've gone either way. It could've killed the market or it could have created a market boom. Fortunately, it was the latter," said Michael C. Barnes, executive director of the Center for Lawful Access and Abuse Deterrence.
 
Generic manufacturers argued that blocking them from making cheaper OxyContin would hurt patient access. OxyContin, on average, costs about $7.50 per pill, but generics would be at least 30% cheaper, analysts said.

The FDA—which had been under pressure from lawmakers to take action— said it wanted to balance the risks of allowing original versions of OxyContin, with the benefit of having lower-priced generics available.

On May 10, the FDA faces a similar decision on the efficacy of the abuse-deterrent features implemented with Endo's Opana drug."

I said before that the FDA is similar to the Supreme Court. In reality, it may be just as powerful, but it is far less representative and accountable to the American people. We don't know who decides at the FDA, or the details of those decisions. Michael Barnes' statement that the FDA could have killed a market or created a boom based on one decision is chilling. What do you think about the FDA's influence on market trends? In my opinion, it is an invitation to corruption.


1 comment:

  1. How about some transparency here? I suggest having the research backing these decisions available in a town hall-type forum before the FDA unilaterally raises the cost of medicines that have been around for decades.

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