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Health Care and Medical Research
Medicare. BIO is urging the new Congress early in this session to pass Medicare reform and private-sector-based outpatient prescription drug coverage. But BIO also contends that in addition to a new drug benefit, Congress and the administration must act to remedy deep cuts made to the Medicare program's Hospital Outpatient Prospective Payment System. Those cuts, which took effect January 1, 2003, are resulting in reimbursement well below drug acquisition costs in many instances.
Follow-on Biologics. With many first-generation recombinant DNA products approaching patent expirations, potential competitors are agitating for new laws and/or regulations to expedite the approval of follow-on products. BIO supports approval of safe, effective follow-on biologics, but clinical testing remains the only means of ensuring their equivalence with pioneer products. BIO's position, therefore, is that clinical testing must be a component of any approval pathway for such products.
Global Health. Recent studies have concluded that biotechnology could dramatically improve health in developing nations. BIO will work with the administration and Congress to develop policies to provide incentives and strengthen markets for companies that develop products to diagnose, prevent and treat neglected diseases in the developing world.
Cloning. Reports of the first cloned human baby have prompted a call from the White House and the GOP-controlled Congress for a ban on all applications of human cloning, including cloning for therapeutic research. BIO opposes the cloning of human beings, but will continue to express strong support for therapeutic cloning research technologies that offer great medical promise. The FDA is expected to add fuel to the debate when it publishes in early 2003 a guidance document on the safety of food products derived from transgenic and cloned animals.
Human Subject Protection. Over the last two years, the momentum has been growing for reforms that strengthen protections for people who participate in clinical trials. BIO supports these efforts, in particular measures to streamline trial protocol review, make regulations consistent across state lines, and require disclosure of financial relationships between and among researchers, investigators and institutional review boards.
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