New York Times: Medical Device Regulation Weak

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EDITORIAL

Cozy Deal

Published: April 28, 2012  New York Times  (FiDA Blog bold added.)

                                   

Congress long ago shirked its responsibility to provide the Food and Drug Administration with sufficient money to do its job. So the companies that make drugs and medical devices — complaining that it took too long to win approval for their products — offered to pay “user fees” if the F.D.A. would hire more people to evaluate their applications. Critics charge that those cozy cash-fed agreements have given industry far too much influence over the regulatory process. Industry says that without the money, patients would have to wait far too long to get access to new treatments.

The F.D.A. needs more resources to do reviews. But Congress, which must ratify a new round of deals by the end of the year, needs to do a better job of ensuring that regulations are not weakened in the process.

The user fees, which cover more than 60 percent of the cost of reviewing drug applications and 20 percent of reviewing devices, have cut F.D.A. review times. But legitimate concerns have been raised that the negotiations have given away too much to industry — with too much emphasis on quick approvals while weakening protections, like the quick removal from the market of drugs or devices that are found to be dangerous.

In some cases Congress, heavily lobbied by industry, has impeded the F.D.A.’s ability to act, as when it required the agency to use the “least burdensome” approach for seeking information from industry. In some cases, the agency seems to have been loath to bite the hand that is financing it. A survey last year by the Union of Concerned Scientists found that 40 percent of the agency’s scientists felt that the consideration accorded to business interests was “too high.” A recent report from Public Citizen, a consumer advocacy group, noted that device-related deaths had been running above 2,000 a year and the average number of high-risk and moderate-risk recalls had doubled in recent years.

Regulation of devices has always been far less rigorous than drug regulation, and last week the Senate health committee approved a bill that would partly address that problem by beefing up the agency’s ability to require post-market surveys of medical devices and impose more stringent rules on devices that raise safety concerns.

But the Senate bill and pending House legislation would fail to close a worrying loophole. Currently, the vast majority of medical devices are cleared for marketing without clinical testing or weighty evidence that they are safe and effective; a manufacturer simply has to show that its device is “substantially equivalent” to one that has previously been cleared — even if the earlier device was recalled by the manufacturer after safety problems.

The best approach would be for the government to fully finance the F.D.A. That is unlikely to happen. So before it ratifies any new deal on “user fees,” Congress must ensure that patient safety is the first priority.