Five Ways To Fix The FDA

The U.S. Food and Drug Administration may have the world's toughest job. A quarter of every dollar Americans spend annually--some $1 trillion in total--is regulated by the FDA. From the start, the safety of medicines has been the agency's most sacrosanct calling. The FDA was founded after a 1937 incident in which a poisonous medicine killed 107 people, most of them children. Since then, the FDA has become synonymous with drug safety. In a sense, "FDA approved" is the brand that the entire $216 billion U.S. drug market is founded upon. Dilute the confidence of the public in the agency, and many billions of dollars in current and potential sales vanish overnight. That's exactly what's happening right now in the wake of the biggest drug withdrawal ever. Last September, Merck (nyse: MRK - news - people ) pulled Vioxx, its $2.5 billion arthritis drug, after it found that the drug doubled the risk of heart attack and stroke. Very worrisome but less conclusive evidence has also linked Celebrex and Bextra, both made by Pfizer (nyse: PFE - news - people ), to some heart risk. Celebrex and Vioxx have been on the market for five years. It's possible that tens of thousands of heart attacks would have been prevented if these drugs had been subjected to more scrutiny. Did the FDA fall short? And if it's broken, how do we fix it? Searching for answers, we asked experts in drug safety what they thought was wrong, and how to fix it. Based on their answers, we've come up with a five-step plan for making sure medicines are safe. This can be done without slowing the path of life-saving drugs to patients, and, although it will cost a great deal of money in the short term, it could save the U.S. government money in the long run by making sure that the benefits of the medicines we take outweigh the risks. It's vital that change comes quickly, because right now the current crisis in drug safety could well push the agency in the wrong direction. Here is our five-step plan: