Dancing the FDA tune

The Food and Drug Administration needs serious reform and Congress must stop dancing around the fact.
The FDA's failures over Cox-2 inhibitors were widely documented. The painkillers Vioxx and Celebrex were heavily marketed and then found to increase users' risks of heart attack and stroke. Vioxx was recalled. A Celebrex trial was halted. Now come congressional investigators with a damning conclusion to their critique of the FDA: The agency doesn't have a reliable process for tracking safety problems involving drugs already on the market.
The report by the Government Accountability Office reinforces this page's view that the FDA needs help balancing its mission of regulator for public health with its role helping get new drugs to market.
The public has little confidence in the FDA. To restore the public's trust, the FDA must become a stronger, more-assertive version of its passive self.
The agency needs a stronger hand in forcing pharmaceutical companies to conduct safety studies of drugs already in use by the public. Congress ought to get behind the efforts of Sen. Charles Grassley, R-Iowa, who has proposed drug-safety legislation requiring companies to respond with studies when safety concerns about existing drugs arise and spread.
The FDA would be given the authority to punish companies that don't fall in line with heightened safety requirements.
The pharmaceutical industry doesn't support increased requirements. But let's not forget the disclosures that drug giant Merck and federal regulators allowed Vioxx to remain on the market despite growing evidence of its dangers.
Congress should support Grassley's sharply focused reform efforts. The Iowa senator's view of the FDA is admirably lucid.
The Government Accountability Office has laid to rest any lingering doubts about the FDA: The agency fails when it comes to drug safety. Time now to fix the broken system.