The Nation - Senate OKs drug-safety bill - Legislation that would boost FDA enforcement powers and create a new system to spot risks now goes to Bush, who is expected to sign it.
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 would renew industry user fees that fund the FDA's review of medications and medical devices submitted for approval.
The Senate passed 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 President Bush is expected to sign it, congressional aides said.
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 agency decision-making. It also would take steps to reduce FDA reliance on outside advisors 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. But some scientists said that the new drug safety system could take years to refine and that in the meantime, consumers were 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 B. McClellan, FDA commissioner from 2002 to 2004. "It's going to shift the focus away from information provided by the drug manufacturers to much broader sources of information in our healthcare 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.
"This is a wide-open area, [and] nobody really knows how to do it," said Sean Hennessy, an epidemiologist at the University of Pennsylvania medical school. "There will be potential threats that are later disproved. The danger is that people will act on information that is later shown to be false." And that could be damaging to the FDA's credibility.
