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U.S. Department of Health and Human Services

For Industry

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FDA Marks Orphan Drug Law Milestone

 
When President Ronald Reagan signed the Orphan Drug Act into law on January 4, 1984, he enacted one of the most important pieces of health care legislation today. Fewer than 10 products supported by industry for rare diseases came to market between 1973 and 1983. Patients with rare diseases were in desperate need for treatments. 
 
The Orphan Drug Act (ODA) provided the first meaningful incentives to sponsors to develop needed medical products for the estimated 25 million Americans with rare diseases, defined under the ODA as diseases or conditions that affect fewer than 200,000 people in the United States. Since its passage over 400 products for rare diseases have received marketing approval.
 
FDA celebrated the 30th Anniversary of the passage of the ODA on January 7, 2013 from 10:30 am to 12:30 pm. The program highlighted this important legislation and included remarks from FDA Commissioner, Dr. Hamburg and recognized the contributions of our many partners in the rare disease community with 30 of our “One of Many Rare Disease Heroes”.
 
 
Click here to view: January 4th Webcast
Click here to read excerpts of the Orphan Drug Act
 
Signature page of the ODA

Image of page 1 of the Orphan Drug Act

 

 

Signature page of the ODA