WASHINGTON -- Since Vioxx was withdrawn from the market in 2004, drug companies, lawmakers and regulators have unveiled one initiative after another to make prescription medicines safer. But they haven't radically altered the way the government handles new drugs.
Now, the expiration of a key drug safety law is driving a flurry of activity that could lead to major changes.
Last week alone, lawmakers introduced two plans and federal drug regulators proposed a third. That's on top of an earlier proposal by the regulators. The House Energy and Commerce oversight subcommittee will hold a hearing on the issue Tuesday.
"You have an odd configuration of the stars that may lend itself to resolution this year," said Sheila P. Burke, who chaired a blue-ribbon panel that studied the issue for the Food and Drug Administration. Burke said it's unusual, and therefore promising, that so many people from all sides are proposing changes.
One reason for the frenzy: Democrats, who get less financial support from the pharmaceutical industry than Republicans, now control Congress.
Under a law that expires this year, manufacturers pay fees to the Food and Drug Administration to review the safety and effectiveness of new drugs.
Without the money, approval of new medicines would grind to a halt. So legislators see the renewal of user fees as an opportunity to consider other drug safety reforms.
"Congress will act on FDA-related legislation this year, and meaningful structural reforms to the agency need to be a part of what Congress does with regard to drug safety," said Sen. Charles E. Grassley, an Iowa Republican and outspoken FDA critic who offered one reform plan.
The House Energy and Commerce Health subcommittee expects to consider drug safety in its deliberations over renewing user fees, said a spokesman for the chairman, Democrat Frank Pallone Jr. of New Jersey. The Senate Health committee says it will do the same.
FDA officials kicked off the recent spate of proposals last month with one that would increase user fees to pay for monitoring the safety of drugs after they've gone on sale. They also recommended new fees to cover the cost of reviewing direct-to-consumer television advertisements. Critics say those ads encourage people to buy drugs they don't need.
"The proposed recommendations would support significant improvements in FDA's ability to monitor and respond to emerging drug safety issues," Health and Human Services Secretary Michael O. Leavitt said in a statement.
