U.S. Chamber of Commerce Releases Report on Orphan Drugs

WASHINGTON, D.C.—The U.S. Chamber of Commerce's Labor, Immigration and Employee Benefits division today released a report entitled: Orphan Drugs: Supporting Innovation to Address Unmet Medical Need. The report highlights the unique role that orphan drugs play in treating patients who suffer from rare diseases, and the importance of enacting policies that encourage the continued development of these products.

Orphan drugs are pharmaceutical products used to treat people who have been diagnosed with a rare disease. The Food and Drug Administration defines this as a disease that affects fewer than 200,000 Americans. Products used to treat these diseases can receive orphan drug status under the 1983 Orphan Drug Act.

"This balanced report will help highlight the facts and various policy issues surrounding the current debate concerning orphan drugs and the degree to which these drugs should receive marketplace protection," said Randy Johnson, senior vice president of the Chamber's Labor, Immigration, and Employee Benefits division. "A reasonable, but not disproportionate, degree of exclusivity is important so that companies can recover their investments and continue to develop new treatments for rare medical conditions while also facilitating affordable biosimilar products."

"The issue surrounding orphan drugs, their cost of development, and their limited patient base require a better understanding by policymakers," Johnson stated. "This report will help further that end."

The full report is available at: http://www.uschamber.com/publications/reports/0908orphan_drugs.htm

The U.S. Chamber is the world's largest business federation representing more than 3 million businesses and organizations of every size, sector, and region.

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