FDA efforts to improve prescription drug safety encouraging

Feb 6 2007

FDA is "making encouraging moves to strengthen its regulation of drugs that are already on the market," but the "changes fall far short of what's needed to protect millions of unsuspecting patients whose adverse effects may show up only after years of use," a New York Times editorial states.

According to the editorial, prescription drugs approved by FDA often have "been tested in only a few hundred or a few thousand patients -- too few for many kinds of adverse effects to become apparent" -- and the "agency has limited powers to halt sales" of medications after they reach the market and are "being used by millions."

In response, FDA has "developed a more comprehensive approach" to improve prescription drug safety that "should greatly improve the agency's ability to monitor the use of drugs in the real world," the editorial states.

However, "Congress needs to give the agency more money and more teeth: including explicit powers to impose conditions on drugs that begin to look risky, to require additional testing and even to yank drugs from the market," the editorial concludes (New York Times, 2/5).