(Washington, D.C.) November 25, 2003—Carl B. Feldbaum, president of the Biotechnology Industry Organization (BIO), today issued the following statement regarding congressional passage of the Medicare Prescription Drug and Modernization Act of 2003:
"Because seniors and disabled patients comprise a majority of those treated with biotechnology medicines, BIO has long supported expansion of Medicare coverage to include prescription drugs. The landmark legislation passed today ensures that the patients who need biotechnology medicines the most will have access to them.
"It also removes a major layer of uncertainty for the companies and investors developing those medicines. The bill, which President Bush is expected to sign, stabilizes and protects federal reimbursement of biotechnology products and other drugs for some 40 million Medicare beneficiaries.
"Such reimbursement stability is vital to promoting development of hundreds of new medicines that will save lives and reduce disability, and that can save the healthcare system money on hospital stays and procedures. By expanding Medicare coverage to prescription drugs, Congress has shown it recognizes the growing role of drugs in the nation's health-care system.
"Although the new program is slated to take effect in 2006, many of the legislation's provisions will have a near-term impact. Three months after enactment, the Medicare program will launch a $500 million demonstration project covering oral cancer drugs and self-injectable biotech products for rheumatoid arthritis and multiple sclerosis. Until now, Medicare never covered these medicines.
"The legislation also will reverse this year's deep Medicare cuts to biotech products used in the hospital outpatient setting, and it prohibits future application of the concept of functional equivalence, a controversial mechanism by which a new drug could be deemed 'functionally equivalent' to an older one and reimbursed at the same rate.
"For the biotechnology industry and the patients we serve, this legislation is a major milestone."
BIO represents more than 1,000 biotechnology companies, academic institutions, state biotechnology centers and related organizations in all 50 U.S. states and 33 other nations. BIO members are involved in the research and development of health-care, agricultural, industrial and environmental biotechnology products.