It is time for food and drug administration reform.

摘要

I applaud the authors in the November 23,2009, issue of the Archives for identifying the root cause of sub-optimal patient care outcome associated with the medication management delivery process that currently exists in the United States. Patients are suffering because of the lack of evidence-based practice in many settings, despite the United States having the most expensive health care system in the world. Along the same line as the various audiors suggested, I suggest the following critical steps: Revamp the drug approval process. It does not make any sense that a drug gets approved in 2010 just by comparing it against placebo. The new agent must be compared against the other marketed drugs in the same class. As stated in the Commentary by Woloshin and Schwartz, "marketing works," and often precious resources get wasted every year despite the availability of efficacious and less expensive alternate drugs in many cases. We need evidence-based data, and meaningful comparative effectiveness trials are the only solution.