BIO Commemorates the 25th Anniversary of the Orphan Drug Act

WASHINGTON, D.C. (Friday, January 04, 2008) - Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood issued the following statement today commemorating the 25th anniversary of the Orphan Drug Act.  This landmark law helped lead to the development of new drugs and biologics for rare and frequently untreated diseases by granting seven years of market exclusivity to the developer of a new therapy for a disease which affects less than 200,000 people in the U.S. 

“Today we celebrate the 25th anniversary of the Orphan Drug Act. The law has led to a vast increase in the number of therapies available to the more than 25 million Americans living with one of the 7,000 recognized rare diseases and significantly contributed to the growth of the biotechnology industry.

“The biotech industry has historically taken financial risks to develop therapies and cures to serve small patient populations suffering from rare, devastating diseases.  The Orphan Drug Act established some necessary protection to attract the investment required to research and develop these breakthrough technologies.”

“In the ten years before the Orphan Drug Act was signed into law, only ten new drugs were developed for rare diseases.  In the past 25 years, the Food & Drug Administration has approved more than 300 drugs to treat orphan diseases.

“BIO also recognizes the anniversary of the establishment of the National Organization for Rare Disorders (NORD) which serves patients with rare diseases.”

Further information on NORD is available at

Upcoming BIO Events

    BIO-Asia Partnering Conference 

January 28-29, 2008

Tokyo, Japan


    BIO CEO & Investor Conference

February 11-13, 2008

New York, NY


    Partnering for Global Health 

March 10-12, 2008

Washington, DC


    BIO-Europe Spring

April 7-9, 2008

Madrid, Spain


    World Congress on Industrial Biotechnology & Bioprocessing 

April 27-30, 2008

Chicago, IL


    BIO International Convention

June 17-20

San Diego, CA


About BIO

BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and 31 other nations. BIO members are involved in the research and development of healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the annual BIO International Convention, the world’s largest gathering of the biotechnology industry.  Visit for more information on BIO and all upcoming events.