FDA Matters Blog

Archive for the ‘Orphan Drugs’ Category

Orphan Drugs and Bio-Similars: Is 12 Better than 7?

Sunday, May 16th, 2010

In the new bio-similars legislation, orphan drugs were granted protection for the longer of 12 years of data exclusivity or 7 years of market exclusivity. Since both are triggered by the date of approval, many people have assumed that 12 years protection is always better than 7 years protection.

FDA Matters says: not so. Other than patent protection, the Orphan Drug Act’s grant of market exclusivity to orphan drugs is still the best friend of an innovator company. (more…)

Orphan Drugs Return to Center Stage

Friday, May 22nd, 2009

Years of quiet success by the rare disease community have built to a moment where orphan drugs are once again at center stage. At the National Organization for Rare Disorders (NORD) policy summit last week, former FDA commissioner David Kessler led a blue-ribbon panel in front of an overflow crowd of more than 300. This past Wednesday, NIH launched a 5-year, $120 million program called Therapeutics for Rare and Neglected Diseases (TRND). (more…)

© 2009-2012 by HPS Group. All rights reserved. Permission is hereby granted to those wishing to quote or reprint from this site, providing it is properly attributed to FDA Matters: The Grossman FDA Report™.