Senate OKs bill boosting FDA drug oversight

WASHINGTON – Congress gave final approval Thursday to legislation designed to transform the Food and Drug Administration from a passive monitor to an active detective seeking out medications that have been approved for sale but turn out to be hazardous – a problem linked to an estimated 15,000 deaths a year.

The drug safety provisions were the centerpiece of a massive bill that also renews user fees paid by the pharmaceutical industry to finance the FDA’s review of proposed new medications and medical devices. The Senate approved the bill without objection Thursday evening, after the House overwhelmingly passed it Wednesday. The White House has not commented on the final version of the bill, but congressional aides said President Bush is expected to sign it.

In addition to building a new computerized system to spot drug risks, the bill would strengthen the FDA’s enforcement powers and require greater disclosure of private and public clinical research and of FDA decision-making. It would also take steps to reduce FDA reliance on outside advisers with financial conflicts of interest, as well as create a new program to review drug company advertising.

“This ought to be reassuring for every family about the safety of their prescription drugs,” said Sen. Edward M. Kennedy, D-Mass., one of the main authors of the bill.

Consumer groups hailed the legislation as a major accomplishment, achieved with a high degree of bipartisan consensus – though some scientists said the new drug safety system could take years to refine and, in the meantime, consumers are likely to face more drug scares.

“This is a different way of doing business for FDA, and there are going to be some real challenges in implementing it effectively,” said Mark McClellan, FDA commissioner from 2002-04. “It’s going to shift the focus away from information provided by the drug manufacturers to much broader sources of information in our health care system.”

One important challenge is developing a reliable method of distinguishing between true drug safety issues and false alarms, a problem that experts say is relatively common.

Nonetheless, serious drug reactions appear to be on the rise. According to a recent study of reports to the FDA, there were nearly 90,000 such cases in 2005 – including more than 15,000 that led to a patient’s death and nearly 5,700 in which the patient was left with a disability.

Some of the problems, like the heart risks of the painkiller Vioxx, have been widely publicized, but many receive little notice.