Concern About Panel’s Independence May Create Support for Pending Grassley-Dodd Bill

Due in large part to the types of people who have been appointed as members , Senator Charles E. Grassley (R-Iowa) and FDA safety officer David Graham believe that the FDA’s newly formed new drug safety board will not help to improve the drug-safety situation and, specifically, will not make it any easier for the FDA to take dangerous drugs off the market.  The FDA announced the 15-member board in the fall of 2004; it consists largely of FDA managers, with some input from officials of the National Institutes of Health and of the Department of Veterans Affairs.

In June 2005, Senator Grassley said in a letter to the (then) acting FDA Commissioner Lester M. Crawford that the makeup of the FDA’s Drug Safety Oversight Board led him to conclude that "what we have here is nothing more than the status quo."  In his letter, Grassley pointed out that 11 of the 15 voting positions on the board were assigned to senior managers of the FDA’s Center for Drug Evaluation and Research, the same office responsible for reviewing and approving new drugs.  This observation caused Grassley to ask: "Where are the people responsible for post-marketing surveillance who have allegiances only to post-marketing safety and the public’s well-being, and not to the drugs that they helped put on the market in the first place?" 

At about the same time, the FDA "whistleblower" David Graham reviewed the member composition of the newly-formed Drug Safety Oversight Board and concluded, first, that the panel is "severely biased in favor of industry" and, second, that "the FDA cannot be trusted to protect the public or reform itself."

When asked back in June, Janet Woodcock, FDA acting deputy commissioner for operations, declined to respond to Grassley’s letter or Graham’s comments.  Instead, the FDA’s Woodcock defended the safety board as useful and independent. "The safety board will be able to meet quickly, deliberate and make some strong recommendations if needed," she said. "They will be moving issues up and down on the scale of urgency."

These critiques by Grassley and Graham, however, suggest that Congress might press for action on pending legislation to create a more independent drug safety office. In April 2005 Senator Grassley and Senator Christopher J. Dodd (D-Conn) introduced a bill that would give drug safety oversight responsibility to a board that would have considerably more independence from FDA.

(Posted by: Tom Lamb)