Regulatory Focus™ > News Articles > Romney Talks FDA, Medical Device Regulation

Romney Talks FDA, Medical Device Regulation

Posted 02 April 2012 | By Alexander Gaffney, RAC 

Republican Presidential nominee Mitt Romney spoke Monday, 26 March before a gathering at San Diego medical device company NuVasive, telling the audience he thought the US Food and Drug Administration (FDA) is taking too long to approve medical products, including medical devices.

While Romney was mostly focused on the Patient Protection and Affordable Care Act's (PPACA) provisions and the medical device tax, which is slated to go into effect at the end of this year, he also opined on FDA regulatory practices.

"The length of time it takes to make it through FDA keeps getting longer, and longer and longer," said Romney. "I'm not talking about a month or two months longer, but years longer."

"So Europe with their regulators is able to look at a new medical device, test it, put it in human beings-clinical trials, so to speak-and over some period of time they approve these products," continued Romney. "Then the US comes around -years later, not just months-years and years later, and is finally able to give to our citizens the technology which has often times been developed right here in the US."

Romney said the agency is part of an "attack on free enterprise" by "the thousands upon thousands of bureaucrats that work in Washington."

"Not only do we have to pay for [bureaucrats], but they have to do something every day," explained Romney. "So, they look at things they can do, alright? Places they can interfere."

Read more:

Romney: Government Workers Just Look for 'Places They Can Interfere' (h/t Beaker's Blog)

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