Judicial Watch • Federal Agency’s Health Hazard

Federal Agency’s Health Hazard

Federal Agency’s Health Hazard

JUNE 28, 2006

The government agency responsible for protecting public health and safety neglects to enforce many federal laws because it could negatively affect the profits of the wealthy companies that pay the agency hundreds of millions of dollars in “fees.”

A new study released by the House Committee on Government Reform details the huge decline in the Food and Drug Administration’s (FDA) enforcement of crucial laws against wealthy pharmaceuticals and other companies that make medical devices.

The 24-page report reveals a 54% decline in the number of warning letters that the FDA issued to drug companies and medical device makers in 2005 although there was no increase in regulation compliance from the companies. Additionally, the seizure of mislabeled, defective or dangerous products decreased 44%.

Also identified are 138 cases in which FDA supervisors did not take enforcement actions recommended by their own inspectors. They include an asthma medication containing an ingredient with dangerous side effects for children, a hangover remedy with toxic levels of caffeine and nitrogen tanks mislabeled as oxygen. One of the tanks was connected to a nursing home’s oxygen delivery system and four patients died as a result.

So, why would the nation’s oldest consumer protection agency look the other way while rich pharmaceutical companies endanger the health of Americans? Money and lots of it. The medical research director at one consumer advocacy organization points out that the FDA receives nearly $400 million a year in “fees” from drug makers, creating an industry friendly FDA.

The agency’s dismal recordkeeping is also a huge problem because it is unable to track and maintain adequate records of agency enforcement decisions, a violation of the Federal Records Act.

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