lunes, 2 de julio de 2012

Too Much: Regulation? | Medical News and Health Information

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Too Much: Regulation? | Medical News and Health Information



Too Much: Regulation? -- Research Summary

BACKGROUND: The U.S. Food and Drug Administration carefully scrutinizes drugs and devices before they are deemed safe for the American public. While some say the agency is looking out for public safety, others claim the approval process for life-saving medical devices takes too long. According to one study conducted by Dr. Josh Makower from Stanford University, for low- and moderate-risk devices, the process to navigate the FDA took companies an average of three months to two years longer to be granted approval than it did for a similar approval from European regulators. For higher-risk devices, the process in the United States took five-times as long as Europe to grant approval.
(SOURCE: Los Angeles Times)


NOT ENOUGH ACCESS? Some doctors and patients believe the FDA’s slower approval process is denying some Americans the treatment they need. "It’s frustrating for us that we see these things available in other countries, and yet the approval process in the United States is so slow that we don’t have access, and our patients don’t have access to these really game-changing devices," David Chang, M.D., an ophthalmologist at UCSF, told Ivanhoe. "I think the whole system has to be looked at, and I think we have to look at it with the big picture of what needs to be done to streamline the process." Dr. Chang believes having an advocate within the FDA to examine the benefits of certain devices is one potential improvement that could be implemented. He also believes working with other countries and using data that was accumulated outside of the United States could streamline the process. 


MEDICINE MOVING TO OTHER COUNTRIES? Some device companies are seeking early approval in Europe because it’s easier and faster. "It’s just a shame to see companies now really looking outside the U.S. to bring products to market," Dr. Chang told Ivanhoe. In Europe, a device must be shown to be safe, while in the United States, it must also be shown to be effective in treating a disease or condition. Also, European approvals are handled by third parties. A study found the rate of recalls in Europe was similar to that in the United States, suggesting that faster approvals overseas are not hurting patients.
(SOURCE: New York Times)


THE FDA’S STANCE: The FDA defends their approval process. In a recent report, they point to 12 products that were approved in Europe first but were later found to be dangerous or ineffective, stating: "There is no requirement in the EU that a high-risk device provide an actual treatment benefit to patients…EU can fail to predict dangerous risks and lack of effectiveness in actual use." They also point out that U.S. patients have access to low- and moderate-risk devices at least as early as patients in Europe.
(SOURCE: FDA, Unsafe and Ineffective Devices Approved in the EU that were not Approved in the U.S.) MORE

 Too Much: Regulation? -- Research Summary | Medical News and Health Information

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Too Much: Regulation? -- In Depth Doctor's Interview | Medical News and Health Information

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