After nearly a decade of resisting, biotech companies want a law passed this year that lets generic drug companies sell cheaper copies of their medicines. Biotechs, of course, have never had the competition from generics that brand-name drugmakers face when patents expire. While the FDA lacks authority to approve generic biotechs, several bills introduced in Congress during the past year would change that, theAssociated Press writes.
Biotech companies say they are ready for that change - so much so that their main trade group is making the legislation a top priority in 2008. And the Bush administration recently said it supports that aim. The shift comes as election-year politics are expected to turn Washington away from biotech's interests. Many political observers expect Democrats to gain more power in Congress this November, which could tilt favor to the generic drug industry.
Faced with that possibility, the biotech industry wants an agreement as soon as possible. "We've made good progress in having this issue understood by the people who are in place on Capitol Hill now," Jim Greenwood, president of the BIO trade group, told reporters at a press event in Washington. "And we'd like to get it done this year so we don't have to start all over again."
The group spent more than $3.6 million lobbying Congress and federal agencies on issues including biogenerics in the first half of 2007. But BIO must also consider that Barack Obama, Hillary Clinton and John McCain have all advocated generic drugs as a health care cost-cutter.
The US currently spends $40 billion per year on biotechs, including Genentech's cancer drug Avastin, which costs more than $50,000 for a year's supply. With those costs expected to rise, biogenerics could prove an attractive cost saver for future administrations. The Bush administration, which had previously been silent on the issue, said earlier this month it would like to see FDA gain the power to approve biogenerics this year. And FDA officials have also pledged to work with lawmakers on a bill, the AP reminds us.
Getting legislation to the president's desk, say analysts, won't happen until companies and Congress can hammer out disagreements on when and how biogenerics are approved. Lehman Brothers analyst Tony Clapsis told investors in a recent note that "the more constructive attitude from the biotech industry and the FDA will help to develop a consensus in Congress about how to move forward, but that moving forward will happen in 2009."
The generic drug industry is content to wait until then, instead of playing by a timetable set by biotechs and brand-name drugmakers, the AP writes. "With nowhere else to turn, BIO and PhRMA now want to come to the table to cut a deal," Kathleen Jaeger, president of the Generic Pharmaceutical Association, told the group's annual meeting on Tuesday. "They want unprecedented and excessive market exclusivity and patent protections to ensure their monopolies."
The biotech industry says drugs must be on the market at least 12 years before competing generics can launch. The generic industry backs proposals for less than five years of exclusivity. The two industries also disagree on FDA readiness. Generic advocates would like the agency to start reviewing products immediately, but biotechs wants new regulations in place first, a process that could take years. "The biotech industry's idea of a bill is one that will make sure they don't have any competition for dozens of years to come," Jake Hansen of Barr Pharmaceuticals, tells the AP.
Senate lawmakers drafted a bill aimed at bridging the divide last year, but they were unable to bring it to a final vote. Lawmakers on the House side have made even less progress. A spokeswoman for John Dingell, who chairs the House Energy & Commerce Committee, which oversees the FDA, says he's interested in tackling biogenerics, but has no timetable for legislation. No hearings on the issue have been scheduled in the House.
Source: The Associated Press