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’s 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”.
