The Senate approved a package of FDA reforms Wednesday — but turned away several other efforts to boost the agency's authority.
Lawmakers voted to give the agency new power to force drug companies to conduct studies on the safety of drugs already on the market. The Senate also voted to give the FDA new authority to change drug warning labels without first negotiating with firms and approved an increase in fines if companies fail to comply with FDA orders.
FDA reforms have been on the congressional agenda since 2004, when the drug company Merck was forced to pull Vioxx from the market after evidence emerged that the pain drug increased the risk of heart attack and stroke.
That was followed by a series of other safety missteps, some of them leading to charges from FDA scientists that the agency did not heed safety warnings.
"The FDA should be the gold standard for safety. But its luster has been tarnished in recent years by failure to protect the American people from unsafe drugs," says Sen. Edward Kennedy, D-Mass., the bill's main sponsor.
The bill passed 93-1 after a week of debate on the Senate floor that at times involved intense behind-the-scenes negotiations.
Many lawmakers who supported the bill in the end said it was significantly weaker than they had wanted.
"It was alright," Sen. Byron Dorgan, D-N.D., says of the bill. Dorgan initially got broad support for an amendment allowing U.S. consumers to import lower-cost drugs from Canada and other industrialized countries. But the Senate blocked the amendment because of a threatened White House veto.
Lawmakers also narrowly rejected an attempt to clamp down on industry conflicts of interest on FDA expert advisory panels that recommend new drugs for the market. One amendment would have restricted panels to just one member with financial ties to industry. It was rejected after a tie 47-47 vote.
Watchdog groups have criticized the panels, and the FDA recently adopted stricter conflict-of-interest standards.
Kennedy's original bill gave the power to block direct-to-consumer drug advertisements for the first two year's of a medication's marketing life. The provision was taken out before a final vote.
The Senate also rejected an amendment to create an independent FDA office to monitor the safety of the U.S. drug supply. That office is now under the authority of the division that approves new drugs, an arrangement some lawmakers called a conflict of interest.
The bill was the subject of intense lobbying by the pharmaceutical industry, which opposed drug importation and broad new regulatory authority for the FDA.
Billy Tauzin, president of the Pharmaceutical Research and Manufacturers of America, praised the bill in a statement after it passed.
"In general, the legislation passed by the Senate will preserve — and even strengthen — the FDA's ability to do its job," says Tauzin, who chaired the House committee overseeing FDA in his former role as a Republican Congressman from Louisiana.
Reaction of Consumer Groups
Consumer groups gave the bill a mixed reaction. Consumers Union praised the bill in a statement but also expressed disappointment that stronger FDA authority and drug importation were dropped.
But Sidney Wolfe, MD, director of Public Citizen's Health Research Group, says the bill won't improve patient safety.
Wolfe says it failed to address charges that the FDA routinely ignored the advice of scientists over safety issues. He also criticizes the approval of a decade-old program that allows drugmakers to pay millions of dollars in user fees into the FDA in exchange for faster drug review times.
"If anyone thinks [the fees] do not alter FDA's vigilance over the industry, they're just delusional," Wolfe tells WebMD. "Anyone who thinks this is going to slow or halt the seemingly endless series of drug disasters is really wrong."
Lawmakers approved one amendment boosting fines that the FDA can impose on drugmakers from $10,000 to $250,000.
"These penalties need to be more than just an insignificant cost of doing business in order to affect behavior," says Sen. Charles Grassley, R-Iowa, who sponsored the measure.
The bill now goes to the House of Representatives, which is considering a set of slightly different reforms.