On the Right Track

In the U.S., moving a drug from the lab bench to the pharmacy's shelves takes about 10 years. That's because the Food and Drug Administration (FDA) sets a high bar — the rigorous three-stage clinical trial system — to ensure that drugs are safe and effective.Late last month, the agency announced that it's pushing a controversial autism treatment through the system a bit more quickly.CM-AT, a drug made by New York biotech CureMark, is a powder that helps children with autism digest proteins and, supposedly, improves brain function. Its creators haven't published any information yet about the drug's effectiveness or how it works. But last year, after submitting positive preliminary results to the FDA, the company began a stage-III clinical trial at 12 medical centers.Read more at...SFARI, March 2010.