House panel OK's allowing FDA to compel more drug tests

WASHINGTON -- The Food and Drug Administration could compel drug makers to conduct additional clinical trials after it approves their products under an amendment passed by a US House committee.

To speed drug approvals, the FDA frequently defers some clinical trials until after a product is introduced on the market. But companies have failed to complete two-thirds of the post-marketing studies they pledged to conduct for drugs now sold to millions of Americans. Currently, the FDA does not have the authority to force drug makers to finish the trials.

Under the amendment, which was attached to a must-pass appropriations bill, the agency could begin proceedings to stop the sale of specific drugs if promised clinical trials for those products are not done.

Representative Rosa DeLauro, Democrat of Connecticut, who offered the amendment, said it was triggered by a recent report from the Government Accountability Office that pointed to deficiencies in how the FDA handles post-marketing drug safety.

The GAO urged Congress to consider giving the FDA authority to require that drug makers follow through on clinical trials.

''They do not have that legal authority, even when we find out there are serious health concerns," DeLauro said. ''We're talking about public health and public safety."

The FDA did not immediately respond to a request for comment.

The agency already has ''broad authority to monitor and ensure the safety of prescription drug products after approval," Caroline Loew, senior vice president of the Pharmaceutical Research and Manufacturers of America, said in a statement. PhRMA lobbies on behalf of the drug industry.

The FDA requested such post-marketing trials for 73 percent of new drugs the agency approved from 1988 to 2003, according to the Tufts Center for the Study of Drug Development. Manufacturers pledged to conduct an average of 4.4 clinical trials involving 920 patients, Tufts found.

''America's pharmaceutical research companies and the Food and Drug Administration take the post-market surveillance of prescription drugs seriously and have taken significant steps to ensure patient safety is never compromised," Loew said.

Sidney Taurel, Eli Lilly and Co. chief executive, said having strong incentives to ensure companies abide by their commitments makes sense.

But Taurel, in Washington to meet with members of Congress on an unrelated matter, said forcing manufacturers to withdraw a drug from the market was not an appropriate penalty.

''I would think that taking products off the market would hurt patients in many cases," Taurel said.

DeLauro's amendment is among other actions taken by Democrats in advance of a comprehensive FDA reform bill expected to be introduced in the Senate this summer. New York Democrat Maurice Hinchey, for instance, tacked an amendment onto the same House appropriations bill to sharply limit the number of outside scientists with drug company ties who vote on advisory committees that guide FDA decisions.

Senator Edward M. Kennedy, Democrat of Massachusetts and co-sponsor of the comprehensive FDA reform bill, said it will address shortcomings with post-market drug safety.

The amendments offered by DeLauro and Hinchey were to an agriculture spending bill the House is scheduled to vote on next week. The bill includes $18.4 billion in discretionary spending under lawmakers' control, and provides an additional $80 million for countermeasures against avian flu. The committee also approved $1.5 billion for the FDA in fiscal year 2007, increasing its drug safety funding by $6 million more than President Bush requested.

Diedtra Henderson can be reached at dhenderson@globe.com.