Battle in the Senate over FDA

Mar 7 2005

In the congressional battle over the safety of America's prescription drugs, two University of Washington experts with opposing views have been enlisted into the fray.

Dr. Bruce Psaty and Thomas Fleming appeared before a Senate committee considering potentially major changes to the Food and Drug Administration.This follows the debacle over the withdrawal of the painkiller Vioxx because of links to heart problems.

Psaty, is an outspoken advocate for setting up an independent office to handle drug-safety issues. He is co-director of the cardiovascular research unit at the UW, and told the Senate Health, Education, Labor and Pensions Committee of a "safety lag" at the FDA and that pharmaceutical companies have too much influence on the FDA.

Earlier, Fleming, chairman of the biostatistics department at the UW, told the same committee, "The FDA is not broken ", he defended the FDA and was against the creation of a separate group, outside FDA, to review safety or efficacy.

The fact that the two witnesses from a select list of 10, are from the UW speaks highly of UW Health Services in national medical issues. It also shows politically astute behaviour by dueling senators and could be the start of a congressional battle over legislation that will be opposed by the pharmaceutical industry and many FDA officials.

Psaty spoke before the Senate Finance Committee in November, and has been working with Sen. Charles Grassley, R-Iowa, and Sen. Chris Dodd, D-Conn., on a bill that is expected to be introduced in the next two weeks, to create an independent safety group to replace the existing Office of Drug Safety. Democrats Dodd and Edward Kennedy invited him to testify.

Fleming who has served on advisory committees at the FDA for 20 years wants Congress to provide more money to the FDA to better review clinical trials before new medicines are approved, and more post-marketing studies once the drugs are being used by larger segments of the population.

He testified that "the FDA proceeded in a proper manner" regarding the development of risk-benefit assessments for Vioxx and similar drugs. He has great respect for the leaders at FDA and believes them to be fair and highly effective.

Fleming was one of the members of an FDA advisory committee that voted in favour of keeping the arthritis drug Celebrex on the market, though Fleming did not support the decision to allow Vioxx to return to the market.

The Republican majority on the health committee invited him to testify. Democrat Sen. Patty Murray, a member of the health committee, declined to side with either view due to the very complexity of the problem, but questioned the feasibility of an independent drug-safety office, for financial reasons.

Both Fleming and Psaty were praised for their efforts by Dr. Eric Larson, director of the Center for Health Studies at Group Health Cooperative and chairman of the board of regents of the American College of Physicians.

But he agrees with Psaty on the need for a safety office independent of the approval process. The hearing created a controversy for the Republicans who control the Senate. Grassley's, who chairs the Finance Committee, request to testify was rejected by the committee chairman, Michael Enzi, R-Wyo. Powerful senators such as Grassley usually get their say.

He has now formed an alliance with Dodd to introduce the bill for the drug-safety office, and this has mobilized the pharmaceutical lobby's resistance. Enzi has indicated that he does not see the need for the new office. FDA officials do not support a new structure for drug safety.