FDA Fails To Timely Detect Emerging Unsafe Drugs Because Of Agency Flaws And Limitations

A Government Accountability Office (GAO) report released on April 24, 2006 reached the conclusion that the FDA "lacks a clear and effective process" for tracking safety issues related to prescription drugs after they have been given market approval by the FDA.

As explained in an article in the Washington Post about this April 2006 report, the GAO found that inter-agency disputes between FDA’s Office of Drug Safety (ODS) and Office of New Drugs (OND) have occasionally prevented timely action by the FDA when it comes to emerging drug-safety issues. Generally, the OND reviews prescription drugs before they are approved by the FDA to go on the U.S. market, while the ODS is responsible for monitoring adverse events and serious side effects associated with those drugs afterward, or "postmarket".  In addition, according to this April 2006 GAO report, management problems within the ODS itself have delayed the detection of early drug-safety "signals" — as well as subsequent FDA action on the emerging unsafe drug. 

The underlying GAO study of the FDA was requested by Sen. Chuck Grassley (R-Iowa) and Rep. Joe Barton (R-Texas) after the Vioxx recall in September 2004 revealed how the FDA was slow in reacting to increasing safety concerns over that blockbuster painkiller.  In short, for this GAO study researchers examined the FDA’s handling of safety issues concerning these four controversial prescription drugs:

• Baycol (statin);
• Bextra (COX-2 painkiller);
• Arava (rheumatoid arthritis medication); and,
• Propulsid (heartburn treatment). 

Among this set of four drugs, all but Arava were eventually taken off the market by the FDA because of increasing safety concerns.

At present, both ODS and OND are part of FDA’s Center for Drug Evaluation and Research. Sen. Grassley and Sen. Chris Dodd (D-Conn.) have sponsored a bill that would create a new FDA department, tentatively called the Center for Postmarket Drug Evaluation and Research.  This new department would have authority equal to that of the current CDER. The Grassley-Dodd bill has been stalled since its introduction in the first part of 2005.

The April 24 Washington Post article presented comments from so-called "stakeholders" on both sides of the issue of whether drug-safety oversight in the U.S. is adequate.

Caroline Loew, senior vice president of the Pharmaceutical Research and Manufacturers of America, said the industry group "believes that the FDA takes the post-market surveillance of prescription drugs seriously and has taken additional steps over the past couple of years to help ensure that patient safety cannot be compromised." She added that only 3 percent of all approved drugs were later withdrawn. . . .

Alastair Wood of Vanderbilt University, a prominent voice on the FDA’s advisory panel on drug safety and risk management, said the GAO report "confirmed a lot of what people have been saying for some time."

Wood said the FDA is still refusing to take the bold steps he believes are necessary to ensure drug safety. "Frankly, it doesn’t look right now as if much has changed," he said.

Certainly, one hopes that this GAO report will put some new momentum behind the pending Grassley-Dodd bill or some other legislation geared at making the FDA more effective when it comes to identifying unsafe drugs and removing those from the market.

(Posted by: Tom Lamb)