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 FDA 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 FDA 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 FDA 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 FDA'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.” — Excerpts from The New York Times editorial __
