Biotechnology Policy Milestones

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1902

• The Biologics Control Act passes to ensure purity and safety of serums, vaccines and similar products.

1906

• The Food and Drugs Act is signed into law, prohibiting interstate commerce in misbranded and adulterated food, drinks and drugs. (Note: For a detailed FDA timeline, visit http://www.fda.gov/opacom/backgrounders/miles.html.)

1930

• The National Institute of Health is created (later to be pluralized as National Institutes of Health).

1971

• President Nixon calls for a War on Cancer and signs the National Cancer Act into law, stimulating new research.

1974

• Leading biologists call for a voluntary moratorium on recombinant DNA experiments while safety standards are set.

1975

• Some 150 scientists, attorneys, government officials and journalists meet at the Asilomar Conference Center near Monterey, Calif., to discuss recombinant DNA research and develop strict safety protocols.

1976

• The NIH adopts guidelines for federally funded recombinant DNA research, with oversight provided by the Recombinant DNA Advisory Committee.

1980

• The Supreme Court decides in Diamond vs. Chakrabarty that anything made by "the hand of man," including biotechnology-modified organisms, is patentable. The decision helps open the floodgates to a wave of investment that includes the first biotech IPOs.

• The Patent and Trademark Act Amendments of 1980-commonly known as the Bayh-Dole Act-lay the ground rules for technology transfer from academia to industry. The act creates a uniform patent policy among federal agencies that fund research and specifies that federal grant recipients-such as universities and small businesses-own federally funded inventions.

1983

• The Orphan Drug Act is signed into law, creating new incentives to conduct R&D on therapies for rare diseases. More than 250 orphan drugs have reached the U.S. market in the years since.

1988

• The U.S. Patent and Trademark Office grants Harvard University a patent for a mouse used for cancer research (the OncoMouse®).

• The United States launches the Human Genome Project when Congress appropriates funds for the Department of Energy and the National Institutes of Health to support research to determine the structure of complex genomes.

1992

• The FDA clears the way for agricultural biotechnology products with a safety assessment and guidance to industry.

• The Prescription Drug User Fee Act is signed into law, instituting fees for drug approval applicants that provide the FDA with resources to review products faster. The successful program is reauthorized in 1997 and 2002 and is up for reauthorization again in 2007.

1993

• The Biotechnology Industry Organization (BIO) is created out of the merger of two predecessor organizations, the Industrial Biotechnology Association and the Association of Biotechnology Companies. (A history of BIO is posted on bio.org in the "About BIO" section.)

1997

• The Food and Drug Administration Modernization Act (FDAMA) is signed into law, codifying administrative changes begun in 1995 and introducing new reforms. Provisions include criteria for fast-track drug development, easier patient access to experimental drugs and medical devices, and an online database of clinical trials.

1998

• Congress undertakes a doubling of the National Institutes of Health budget in five years, raising it to $27 billion by 2003.

2000

• The Biomass Research and Development Act is signed into law to promote conversion of biomass into biobased industrial products.

2001

• President Bush announces that federal funding will be made available to support research using embryonic stem cell lines created as of Aug. 9, 2001.

2002

• The Farm Security and Rural Investment Act includes biotech measures such as significantly increased funding for research and risk assessment and new programs for promoting biotechnology in developing countries.

2003

• The Medicare Modernization Act becomes law, providing prescription drug coverage for senior citizens and the disabled beginning Jan. 1, 2006.

2004

• The FDA publishes a white paper outlining the Critical Path Initiative, which seeks to expedite drug development by promoting the use of technologies such as computer-based predictive models, biomarkers, imaging technologies and improved clinical trial design.

• The Project BioShield Act is signed into law, providing $5.6 billion over 10 years for the federal government to procure diagnostics, therapies and vaccines to protect Americans from chemical, nuclear and biological warfare agents.

2005

• The Energy Policy Act of 2005 passes, authorizing $3.6 billion in funding for bioenergy and biobased products.

• Pandemic legislation signed into law provides $3.8 billion for preparedness, including $3 billion for medical countermeasures. The legislation also includes liability protection for manufacturers of these products.

Sources:
Access Excellence
Biotech 90: Into the Next Decade, G. Steven Burrill with the Ernst & Young High Technology Group
Biotechnology Industry Organization
Genentech, Inc.
Genetic Engineering News
International Food Information Council
ISB News Report
International Service for the Acquisition of Agri-Biotech Applications
Texas Society for Biomedical Research
Science
Science News
The Scientist