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Congress finally passes bill to give FDA sweeping powers
The US Congress has given approval to legislation that is designed to transform the US Food and Drug Administration by increasing its funding and expanding its powers.
The Senate passed the bill without objection yesterday evening, a day after the House of Representatives had overwhelmingly cleared it with a 405 to seven vote. The bill now goes to President Bush who is expected to sign it without any further discussion.
The legislation includes the passage of the Prescription Drug User Fee Act (PDUFA) reauthorisation legislation, which was due to expire on September 30 but the FDA had warned that if the fees programmes were not renewed by today (September 21), it would be forced to begin sending layoff notices to nearly 2,000 of its employees. The need to renew said act resulted in Congress proposing other measures that will give the FDA new powers.
For example, the bill gives the agency the authority to require pharmaceutical firms to change drug labels warning doctors of new safety problems, to conduct new studies of treatments already on the market and to limit distribution if needed. It also grants the FDA the authority to fine firms if they do not complete post-marketing studies.
The new laws are also designed to force the FDA to step up its active surveillance regarding safety and create a new programme to review advertising practices. FDA Commissioner Andrew von Eschenbach said he was pleased Congress had approved the bill, as it has reauthorised programmes that were "vitally important to the agency and its continued ability to protect and promote the public health."
Senator Edward Kennedy, one of the main authors of the bill, noted that "this ought to be reassuring for every family about the safety of their prescription drugs," and give "every American greater peace of mind every single day - every time we eat, take our medicine or see our doctor." The industry trade association, the Pharmaceutical Research and Manufacturers of America, called the bill "a crucial step to make our nation's drug safety system - which already is the best in the world - even better."
House of Representatives backs new drug safety legislation
The US House of Representatives has followed the lead of the Senate and voted overwhelmingly in favour of increasing the powers of the Food and Drug Administration.
The House voted 403-16 to approve new legislation, including the passage of the Prescription Drug User Fee Act (PDUFA) reauthorisation legislation which gives the agency an additional $400 million in fees collected from the drug industry. This cash will be used to give the FDA more power over drug safety, including the authority to require post-marketing studies and changes to the labels of approved products.
Under the bill, drugmakers could face fines of up to $250,000 for a violation of failing to comply with FDA directives, and as much as $50 million if multiple violations are committed. For its part, the agency will have to publicly release an analysis of a new treatment's harmful side effects within 18 months of launch or after exposure to 10 000 patients and conduct an annual safety review for specific drugs for the first three years following their arrival on the market.
However one major difference between this new legislation and that passed by the Senate is that the former does not include a so-called pathway for biogenerics. Senator Edward Kennedy had at one point hoped to get language addressing biosimilars added to the compromise safety legislation, but congressional leaders will now send a final version of the drug safety bill to President Bush for approval before the end of summer. Last month, Sen Kennedy and fellow Democrat Senators Hillary Clinton and Charles Schumer, plus Republicans Orrin Hatch and Mike Enzi proposed new biogenerics legislation but a date has not even been set yet for the Senate to vote on the proposed bill.
The Pharmaceutical Research and Manufacturers of America president Billy Tauzin applauded the Housefs approval of the FDA legislation, saying it will "preserve and even strengthen" the agency's ability to do its job, adding that "the significant increases in user fees will provide the FDA the resources necessary to improve and modernise its already-strong drug safety system".
He added that the House PDUFA bill will enable the FDA to hire 27 additional employees to review drug advertisements prior to public dissemination, helping to ensure that benefits and risks are clearly and accurately communicated, noting that "it also will create strong incentives for companies to submit advertisements to the agency before airing them".
"Currently, FDA review times for advertising submissions are long and unpredictable. We believe this bill, like the legislation passed by the Senate, will lead to more expeditious and predictable review times, which ultimately benefits public health," Mr Tauzin concluded, saying that "PhRMA looks forward to continuing to work in a bipartisan manner with Members of the House and Senate to further improve the legislation as it moves to conference".
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