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

Main Category: Pharma Industry / Biotech Industry
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 18 Feb 2008 - 8:00 PDT

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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" (AP/Raleigh News & Observer, 2/15).

Disagreement With Generic Rx Companies
The biotech industry has said that brand-name biotech medications should have market exclusivity for at least 12 years, but generic pharmaceutical companies maintain that such treatments should have market exclusivity for less than five years.

During an annual meeting of the Generic Pharmaceutical Association on Tuesday, group President Kathleen Jaeger said, "With nowhere else to turn, BIO" and the Pharmaceutical Research and Manufacturers of America "now want to come to the table to cut a deal," adding, "They want unprecedented and excessive market exclusivity and patent protections to ensure their monopolies" (AP/Raleigh News & Observer, 2/15). In addition, she said, "Patients need an approval pathway that provides them with access to safe and effective biogenerics sooner rather than later," adding, "A pathway filled with roadblocks to access, including excessive market exclusivity provisions, is an empty promise for countless patients who need these affordable lifesaving medicines" (Chicago Tribune, 2/14).

Jake Hansen, an executive at Barr Pharmaceuticals, said, "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" (AP/Raleigh News & Observer, 2/15).

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