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- July 18, 2011
- Maglio Christopher & Toale
The FDA is in a financial fight for its life, and the outcome could cost many patients theirs. The agency is supposed to protect Americans from dangerous and defective medical products, but it hasn’t done such a great job lately. Huge budget cuts for the FDA could make things a lot worse.
Back in 1992, the US government passed a bill allowing the FDA to supplement its budget by taking money from the industry it’s supposed to police. What a tremendous conflict of interest. Now the FDA will have to rely even more on the cash it can rake in from big businesses in the medical industry. It’s a relationship that gives companies like Johnson & Johnson incredible influence over the decisions made by the FDA.
The recent recalls of metal on metal hip replacements, like the DePuy ASR, shows that the FDA is letting too many problems slip through the cracks without enough accountability. Right now the FDA has a gaping hole in its product approval system. It’s called a 510k approval, and it allows manufacturers like DePuy to slide new devices through the FDA’s system by claiming their products are simple modifications of previously approved devices. No testing. No accountability. No problem getting approved. That’s what happened with the ASR hip implant. The result is a worldwide recall for a medical device that doesn’t work like it’s supposed to.
The FDA is involved in a vicious cycle of money and influence, and until that circle is broken, American patients will continue to be the victims.