Biotechnology Healthcare - November/December 2008 - (Page 28) of the three different bills that have been introduced by members of the Senate and the House of Representatives. “I think things are moving faster in the European Union, but as a result, we have a model across the ocean,” says Duke University Professor of Economics Henry Grabowski, PhD, who directs the university’s pharmaceuticals and health economics program. “Without question, though, it’s important to have a law passed here in TUG OF WAR “Without questhe United States so we Of course, the dilemma tion, it’s imporcan start the process movthat Genzyme faces may tant to have a well be an unusual twist, law passed in the ing. Of course, it will take a while before we see big given that most approval United States so savings — at least, a few applications submitted to we can start the the FDA are likely to be process moving,” years.” The failure to move filed by a company that is says Henry Grafaster reflects substantive not the innovator. None- bowski, PhD, at Duke University. differences among nutheless, the decision illustrates the ongoing tensions and frus- merous parties looking either to trations over the lack of a specified make or save money — biotech and framework — or regulatory pathway generic drugmakers, insurers and — to guide the agency and manu- managed care organizations, large facturers in getting follow-on bio- employers and unions, universities and venture capitalists, and patient logics to market. Despite swelling healthcare ex- advocates and consumer groups. penditures that have helped to focus And their behind-the-scenes tug of attention on the growing number of war over an issue that is highly compricey biologics arriving in hospi- plicated has, for more than a year, tals, clinics, and physician offices, a made it difficult to find a comprodefinitive regulatory pathway for mise. One explanation for the logjam biosimilars does not appear to be close to emerging in the United has been the backdrop pertaining to States. The reason is that most bio- drug safety. There may be nearly logics are regulated by the Public universal agreement that the U.S. Health Service Act, which has no healthcare system is badly broken, provision for follow-on biologics in or at least in need of serious reform, the same way that the Food, Drug but for some, the debate over speedand Cosmetic Act makes it possible ing regulatory approval of follow-on for approvals of generic versions of biologics is not only about cost. “Look at heparin, which has small-molecule compounds. Although Europe adopted a frame- helped the pendulum swing again” work three years ago, Congress has toward safety and away from so far failed to coalesce around any speedy approvals, says Linda Horcomfortable. And so the agency set a higher hurdle. “This kind of situation may not occur for every product — some are more simple, while others are more complex. But I think it does send the message that if there’s even a slight question that the FDA needs answered in order to make an approval decision,” she says, it will mean that the manufacturer will have to submit more clinical data. 28 BIOTECHNOLOGY HEALTHCARE · NOVEMBER/DECEMBER 2008 ton, a partner at Hogan & Hartson, in Washington, and former director of international policy at the FDA. “There is maximum sentiment for protecting Americans from being harmed. The idea that there should be a priority for giving regulatory shortcuts doesn’t match up in the eyes of the Congress.” Timing also has played a prominent part in the ongoing inability to pass legislation. Even though all three previously mentioned bills were introduced in Congress by the early part of this year, the presidential election and the faltering U.S. economy managed to push healthcare costs down the list of priorities and distracted Congress from negotiating an acceptable compromise. Ironically, the delay persisted even as BIO, the biotechnology industry trade group, began pushing for a resolution over concerns that, according to Congressional sources, the next president would be less sympathetic to industry arguments. Nonetheless, as the presidential election becomes history, nearly everyone involved in the effort to provide the FDA with a pathway believes that a bill can be passed sometime in 2009. “The timing has been challenging,” says Jim Greenwood, BIO’s chief executive officer. “It’s difficult in an election year to get anything done on a bipartisan basis. The closer you get to an election, the less inclined Congress becomes to taking on a controversial issue. But if continued fighting postpones passage by years, then everyone loses.” “NO REASON TO WAIT” Indeed, the pressure to pass legislation is growing rapidly. The sour economy may have surpassed healthcare as one of the most pressing problems confronting the coun-
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