Biotechnology Bills in US Congress

Two bills recently introduced in the US Congress could significantly affect the research, development, and commercialization of biotechnology products. First, a trio of legislators introduced the Access to Life-Saving Medicine Act, a bill that would authorize the Food & Drug Administration (FDA) to approve biogeneric drugs. Currently, the FDA has no express statutory authority to do so. A pathway to biogeneric approval, followed by the introduction of biogenerics, would lead to substantial cost savings for employers, insurers, and the US federal government. For this reason, the bill has found a diverse set of backers including General Motors, which is the largest single private medical bill-payer in the US. Although a nearly identical bill failed last year, generic manufactures hope that the current bill will be better received by a Democratic majority focused on reining in government expenditures on drugs. Second, a member of Congress introduced the Genomic Research and Accessibility Act, a bill that would put an end to the practice of patenting genes in the US, a practice cited as a hindrance to the advancement of clinical research. The legislation provides guidelines for the USPTO on what does not constitute patentable subject matter: mainly genetic material, naturally-occurring or modified. While the legislation would prevent future patent grants, it would not act retroactively to invalidate gene patents that have already been granted, which cover approximately 20 percent of the human genome. If enacted, both of these bills will create new challenges for innovators within the biotech industry and may cause a re-evaluation of current business models. For text of the Access to Life-Saving Medicine Act, visit: http://www.henrywaxman.house.gov/pdfs/biologicsbilltext_2.14.07.pdf For a press release about the legislation, see: http://www.henrywaxman.house.gov/issues/health/generic_biologics.htm For text of the Genomic Research and Accessibility Act, visit: http://thomas.loc.gov/cgi-bin/query/z?c110:H.R.977 For a press release about the legislation, see: http://tinyurl.com/2mslvx Summary by: Michael Migus