harrisonsdream
05-10-2007, 11:19 AM
Senate OKs bill giving FDA more power to regulate drugs
Lawmakers send a clear signal that they want stronger action by the agency to protect public health
By ROBERT PEAR
New York Times
WASHINGTON — By a vote of 93-1, the Senate passed a bill Wednesday that would give the Food and Drug Administration new power to police drug safety, order changes in drug labels, regulate advertising and restrict the use and distribution of medicines found to pose serious risks to consumers.
The bill calls for a fundamental change in the philosophy and operations of the drug agency, requiring it to focus on the entire life cycle of a drug — not just the years before its approval — as well as the experience of patients who later take it.
The government would establish a surveillance system to track the adverse effects of prescription drugs. Scientists would analyze data on tens of millions of patients, looking for signals that particular drugs pose serious risks.
In passing the measure, the Senate sent a clear signal that it wants stronger action by the agency to protect public health. Senators said the bill responded to a widespread loss of confidence in the ability of the agency to protect consumers against the dangers of drugs such as Vioxx, a popular painkiller withdrawn in 2004.
The bill appears broadly acceptable to the House, which is working on its own version, and is unlikely to be vetoed.
The administration has not actively opposed the measure, although it says the agency already has all the regulatory authority it needs. Within the agency, officials have been divided about whether they have the enough power.
The bill is widely seen as "must-pass" legislation because it renews authority for the government to collect fees from drug companies to speed reviews of their products. Without action by Congress, the authority expires on Sept. 30.
Billy Tauzin, president of the Pharmaceutical Research and Manufacturers of America, the main trade group for manufacturers of brand-name drugs, said passage of the bill "will preserve and even strengthen the FDA's ability to do its job."
Drug-company executives succeeded in blocking a provision that would have legalized imports of lower-priced medicines from Canada. And they were happy the final Senate version sidestepped a multibillion-dollar question — how to give consumers access to lower-cost copies of biotechnology drugs that cost tens or hundreds of thousands of dollars a year.
Lawmakers from both parties said they intended to create a procedure for approval of such copycat drugs, sometimes called generic biologics.
Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, a consumer organization, said: "The bill would increase collaboration between the agency and the drug industry by increasing the agency's reliance on user fees to finance drug reviews."
Work on the bill began long before Democrats won control of Congress. At a time bills often pass or fail on party-line votes, the Senate drug bill was a proe that could be imposed on a drug company for violating a drug safety plan approved by the FDA. The maximum fine would be $2 million.
"If fines are nothing more than the cost of doing business, you cannot deter bad behavior," said Sen. Charles E. Grassley, R-Iowa, who proposed the increase.
Under current law, the government and drug companies sometimes haggle for months over changes in drug labeling, and the drug agency can request but not compel manufacturers to perform studies after a drug has been approved.
Under the Senate bill, the government could order changes in a label and require the manufacturer to conduct more studies and clinical trials of a drug already on the market.
"For Vioxx, it took 14 months to change the drug's label to warn doctors and patients of the danger," Kennedy said. "Companies routinely promise to conduct studies that are never even started, much less completed."
The bill would also require the government to establish a public database of clinical trials and their results. Lawmakers said this would make it difficult for drug companies to hide evidence of safety problems, as, they said, some companies had done.
The database would also make it easier for patients to learn of clinical trials testing drugs that could save their lives.
Enzi said the bill could speed the approval of new drugs, by giving the agency more tools to protect patients after treatments had been approved. The agency would no longer have to rely on "the nuclear option, which is pulling a drug completely off the market," an extreme step that may disrupt patients' care, Enzi said.
The agency could instead require a manufacturer to adopt a "risk evaluation and mitigation strategy" for a drug that posed serious risks.
As part of a risk-management plan, the agency could require that any television or radio advertisements for a drug describe its risks "in a clear and conspicuous neutral manner," with fines for false or misleading commercials.
To make that sure patients could have access to drugs with extraordinary risks like thalidomide, for a type of cancer, and Tysabri, for multiple sclerosis, the drug agency could require additional precautions like special training for doctors and close monitoring of patients.
Lawmakers send a clear signal that they want stronger action by the agency to protect public health
By ROBERT PEAR
New York Times
WASHINGTON — By a vote of 93-1, the Senate passed a bill Wednesday that would give the Food and Drug Administration new power to police drug safety, order changes in drug labels, regulate advertising and restrict the use and distribution of medicines found to pose serious risks to consumers.
The bill calls for a fundamental change in the philosophy and operations of the drug agency, requiring it to focus on the entire life cycle of a drug — not just the years before its approval — as well as the experience of patients who later take it.
The government would establish a surveillance system to track the adverse effects of prescription drugs. Scientists would analyze data on tens of millions of patients, looking for signals that particular drugs pose serious risks.
In passing the measure, the Senate sent a clear signal that it wants stronger action by the agency to protect public health. Senators said the bill responded to a widespread loss of confidence in the ability of the agency to protect consumers against the dangers of drugs such as Vioxx, a popular painkiller withdrawn in 2004.
The bill appears broadly acceptable to the House, which is working on its own version, and is unlikely to be vetoed.
The administration has not actively opposed the measure, although it says the agency already has all the regulatory authority it needs. Within the agency, officials have been divided about whether they have the enough power.
The bill is widely seen as "must-pass" legislation because it renews authority for the government to collect fees from drug companies to speed reviews of their products. Without action by Congress, the authority expires on Sept. 30.
Billy Tauzin, president of the Pharmaceutical Research and Manufacturers of America, the main trade group for manufacturers of brand-name drugs, said passage of the bill "will preserve and even strengthen the FDA's ability to do its job."
Drug-company executives succeeded in blocking a provision that would have legalized imports of lower-priced medicines from Canada. And they were happy the final Senate version sidestepped a multibillion-dollar question — how to give consumers access to lower-cost copies of biotechnology drugs that cost tens or hundreds of thousands of dollars a year.
Lawmakers from both parties said they intended to create a procedure for approval of such copycat drugs, sometimes called generic biologics.
Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, a consumer organization, said: "The bill would increase collaboration between the agency and the drug industry by increasing the agency's reliance on user fees to finance drug reviews."
Work on the bill began long before Democrats won control of Congress. At a time bills often pass or fail on party-line votes, the Senate drug bill was a proe that could be imposed on a drug company for violating a drug safety plan approved by the FDA. The maximum fine would be $2 million.
"If fines are nothing more than the cost of doing business, you cannot deter bad behavior," said Sen. Charles E. Grassley, R-Iowa, who proposed the increase.
Under current law, the government and drug companies sometimes haggle for months over changes in drug labeling, and the drug agency can request but not compel manufacturers to perform studies after a drug has been approved.
Under the Senate bill, the government could order changes in a label and require the manufacturer to conduct more studies and clinical trials of a drug already on the market.
"For Vioxx, it took 14 months to change the drug's label to warn doctors and patients of the danger," Kennedy said. "Companies routinely promise to conduct studies that are never even started, much less completed."
The bill would also require the government to establish a public database of clinical trials and their results. Lawmakers said this would make it difficult for drug companies to hide evidence of safety problems, as, they said, some companies had done.
The database would also make it easier for patients to learn of clinical trials testing drugs that could save their lives.
Enzi said the bill could speed the approval of new drugs, by giving the agency more tools to protect patients after treatments had been approved. The agency would no longer have to rely on "the nuclear option, which is pulling a drug completely off the market," an extreme step that may disrupt patients' care, Enzi said.
The agency could instead require a manufacturer to adopt a "risk evaluation and mitigation strategy" for a drug that posed serious risks.
As part of a risk-management plan, the agency could require that any television or radio advertisements for a drug describe its risks "in a clear and conspicuous neutral manner," with fines for false or misleading commercials.
To make that sure patients could have access to drugs with extraordinary risks like thalidomide, for a type of cancer, and Tysabri, for multiple sclerosis, the drug agency could require additional precautions like special training for doctors and close monitoring of patients.