FDA Needs Bold New Chief
The Food and Drug Administration in its way does as much as the Pentagon to protect Americans in their daily lives. So it’s scary that the agency has gone leaderless for 20 months.
On Wednesday, the president nominated a 39-year-old medical economist to head the FDA, which regulates everything from after-shave to apple cider--goods whose sales make up one-quarter of the U.S. gross national product.
Mark McClellan looks like a shoo-in. But the Senate should use his confirmation hearing to let him know that after years of inattention, the agency needs a leader willing to kick over apple carts.
Here are three important fixes:
* The agency needs to fast-track genuinely promising new drugs. But the next head must do so without further demoralizing the agency; its own drug evaluation director has called it “a sweatshop environment that’s causing high staffing turnover.” The agency has allowed dangerous drugs to slip through the screening process and almost entirely fails to track their efficacy after approving them. The next FDA head needs to change that.
* The agriculture industry’s indiscriminate use of antibiotics as growth promoters in livestock is contributing to the declining utility of antibiotics for people. The chance that genetically modified fish or insects might escape into the environment and disrupt or wipe out existing species is another threat. The new head needs to address these problems fast.
* Alarming shortages of key childhood vaccines hobble the U.S. health-care system. On Tuesday, the General Accounting Office said some of the shortages were due to the FDA’s failure to “expedite the review of these vaccines.” It’s time to fix this failure.
Sen. Edward M. Kennedy (D-Mass.), head of the Senate committee that will confirm the next FDA head, has praised Bush’s nominee.
Indeed, McClellan, who previously worked as an economic policy aide under Clinton, appears to be the sort of able and relatively nonpartisan policy wonk the FDA needs.
But the position demands something else too: a leader able to produce bold change.
