FDA under heat after Constant Allegations

The healthcare system in the United States isn’t the only thing under heat right now because the FDA decided to join the game.  The Food and Drug administration has tackled a variety of issues over the past few months and very recently Daniel G. Schultz, director of FDA’s Center for Devices and Radiological Health, has resigned by supposedly a “mutual agreement” with Commissioner Margaret Hamburg right after he was accused of approving devices against the judgment of reviewers.  Earlier this year nine scientist wrote a complaint to the Obama administration stating that they were being pressured to approve devices regardless of their professional judgment.

Schultz had led the agency for 5 years and spent a total of 15 years in the department that regulates medical devices, radiation emitting products, and in vitro diagnostics.  Complaints arise specifically from the period of 2006 to 2008 after Schultz approved of a product that FDA reviewers had repeatedly rejected.  Scientists also stated that the product had shown no benefits to patients and had an increased risk compared to similar products already in the market.

FDA troubles aren’t over just yet.  Dr. Janet Woodcock, director of FDA Center for Drug Evaluation and Research, was also very recently accused by Amphastar Pharmaceuticals for purposefully delaying a six year effort by the company for the approval of generic versions of enoxaparin, a drug with a high record of sales.  Amphastar points out that Woodcock worked with competing company, Momenta very closely, publishing a paper with the scientists there and most likely had links with the founder of the company.

Isn’t the FDA what basically regulates a portion of our market?  Drugs approved by them cost more and have a better shot at sales because hey their FDA approved and safer than other much cheaper options.  The FDA is one of the most powerful governmental agencies in the United States and seeing issues like this really disheartens me.

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