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Biotechnology Industry Seeks Passage of Bill To Allow FDA Approval of Generic Biotech Medications

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The biotechnology industry, which for years has opposed bills that would allow FDA to approve generic versions of biotech medications, has made such legislation a priority for 2008, the AP/Raleigh News & Observer reports. Several bills currently under consideration in Congress would allow FDA to approve generic versions of biotech medications, and the Bush administration supports such legislation. According to the AP/News & Observer, the biotech "industry's shift comes as election-year politics are expected to shift Washington away from biotech's interests," and faced with the possibility that Democrats will "gain more power in Congress this November, which could tilt favor to the generic drug industry," the "biotech industry wants an agreement as soon as possible."

Biotech Industry Organization President Jim Greenwood said, "We've made good progress in having this issue understood by the people who are in place on Capitol Hill now," and "we'd like to get it done this year so we don't have to start all over again" (AP/Raleigh News & Observer, 2/15). He added, "If you look at some of the statements that have been made from some of the advocates, initial advocates for the legislation, that maybe they want to slow down and wait until the next Congress, it's frankly because we've been very successful in persuading the key members of Congress that legislation needs to fairly balance the incentives" (Edney, CongressDaily, 2/14).

According to analysts, legislation that would allow FDA to approve generic versions of biotech medications will not become law until biotech companies and lawmakers reach an agreement on the details. Lehman Brothers analyst Tony Clapsis in a recent note told investors 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"

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