WASHINGTON, D.C. (November 21, 2000) -- The Biotechnology Industry Organization (BIO) achieved significant legislative objectives during the 106th Congress and began laying the groundwork for pressing its agenda with a new president and Congress in 2001.
Among the accomplishments in 2000 was adoption of an H-1B visa bill that increases the annual limit on U.S. work visas for skilled professionals to 195,000, said BIO President Carl B. Feldbaum. This will help biotech companies and all other high-tech companies address the shortage of employees with advanced technological expertise.
BIO also was successful in getting Democrats and Republicans to include in their Medicare reform proposals stop-loss protection for seniors. Stop-loss limits people's out-of -pocket expenses when their medical costs are the highest.
No Medicare reform bill passed the 106th Congress. The future course of this debate, whose core issues are drug prices and beneficiaries' access to new medicines, will be greatly influenced by the outcome of the presidential election, Feldbaum said.
BIO worked with various coalitions to increase FY 2001 appropriations for the National Institutes of Health (NIH), U.S. Food and Drug Administration (FDA) and U.S. Patent and Trademark Office (PTO).
BIO also worked with a coalition that was successful in halting Columbia University's efforts to extend by statute its patent on a pivotal process for development of biotech products. The extension would have amended current patent law without public comment or appropriate consideration by Congress.
Another legislative accomplishment this year was congressional and presidential declaration of January 2000 as National Biotechnology Month.
On the industrial biotechnology front, the National Sustainable Fuels and Chemicals Act became law in June 2000, allocating $49 million annually over the next five years for research into applications of biomass as a renewable and environmentally friendly source of energy.
As for agricultural biotechnology, the 106th Congress considered few issues. That posture, however, is expected to change next year when efforts proposing new regulations for biotech crops and foods attract increased attention in the wake of heightened public concerns in 2000 over the impact of biotech crops on the environment and food safety.
Other issues expected next year: continuation of the Medicare reform and drug pricing debates; reauthorization of the Prescription Drug User Fee Act; re-examination of the 1984 Hatch-Waxman law governing patents; and a tax proposal eliminating capital gains taxes on long-term investments in small corporations, including biotech companies.
Major regulatory issues still to be resolved this year are: the PTO's final guidelines for gene-based patents; the Clinton administration's rules for medical confidentiality; new guidelines from the FDA and NIH for oversight of gene therapy research; and new measures from the FDA for biotech foods, including recommendations for voluntary labeling and implementation of a mandatory consultation process before commercial introduction of biotech crops.
BIO represents more than 900 companies, academic institutions and state biotech centers in all 50 U.S. states and 27 other nations. BIO members are involved in the research and development of health-care, agricultural, industrial and environmental products.