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A Good News-Bad News Week For The FDA

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To paraphrase Garrison Keillor, it was not a quiet week for the Food and Drug Administration.

In Keillor’s fictional Lake Wobegon, all the women are strong, all the men are good-looking, and all the children are above average. At the much less bucolic FDA, some scientists and doctors are fighting with administrators over approval of radiological devices, and the administrators are fighting back by monitoring the staffers’ personal e-mail.

Meanwhile, the FDA announced a tentative deal with medical device makers that would double its user fees in exchange for a faster and more transparent device-review process.

So, kind of a roller-coaster week.

Last week began with the news that six former and current FDA staffers, including two doctors and an MD/PhD, had filed a lawsuit alleging that the agency had spied on their nonwork e-mail, which the staffers had accessed through work computers. The suit also charges that the FDA fired or otherwise retaliated against them for leaking documents to Congress and the press.

Science magazine has a good summary of the situation, including a link to the lawsuit. What’s most significant for the medical community and the public is the viciousness of the infighting as FDA managers push for approval of radiological devices against the advice of their own medical and scientific experts.

The Washington Post points out:

Most of the devices the scientists and doctors questioned have received approvals only in the past two years, making it difficult to evaluate whether the fears that the FDA scientists and doctors expressed were valid.

Against that backdrop, the FDA announced on Wednesday the user-fee agreement, which is intended to speed up that very same approval process for medical devices. DOTmed News quoted Stephen Ubl, president of the Advanced Medical Technology Association trade group, as saying:

We believe this agreement is a potential game changer for the FDA, for industry, and, most importantly, for patients and the American economy.

The FDA said the agency would collect $595 million, plus adjustments for inflation, in user fees over five years, allowing it to hire more than 200 full-time-equivalent workers. “The FDA and the industry expect that the agreement in principle would result in a reduction in average total review times,” said the agency’s announcement.

Great. But the FDA has to do a better job in balancing the legitimate economic and political pressure to get useful devices approved with its duty to make sure that the devices are indeed useful as well as safe.

The Washington Post story quotes one of the lawsuit plaintiffs as saying a team of FDA experts three times recommended against approving a computer-aided imaging device for detecting breast cancer. Each time, the plaintiff said, middle managers agreed. Then, after the third rejection, a senior manager approved the device.

Something’s wrong, and adding more money and more staff won’t fix it.

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Meanwhile, the device industry still hates an upcoming excise tax; see our Facebook page.

Related seminar: Radiology Review Course

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One Response to “A Good News-Bad News Week For The FDA”

  1. Radiology Daily»AlertArchive » FDA Publicly Posts Trade Secrets It Was Hiding on July 16th, 2012 at 10:03 am

    […] Six scientists sued the agency over the monitoring last September, and the Washington Post first disclosed the monitoring in January. We reported on the lawsuit in February. […]