Big Changes Needed at the FDA

In the October 26, 2006 issue of the New England Journal of Medicine (pg. 1821), authors Gregory D. Curfman, Stephen Morrissey and Jeffrey M. Drazen make some important points regarding changes needed at the Food and Drug Administration. Their concerns relate to the series of recalls of medications over the past five years that has caused many of us to question the drug approval process as well as the supposed follow-up procedures to track continued drug safety.

Two notable sugestions came from this brief (one page) report. First, to give the FDA greater authority to require post-approval adverse event tracking on any drug on the market. Secondly, to have “…a 2-year moratorium on direct-to-consumer advertising after a new presciption drug has been approved.”

While there are many other issues that need addressing, like the need to get BigPharma’s financial fingers out of the FDA, these are two excellent first steps in assuring drug safety in the U.S.A.