25th anniversary of the Orphan Drug Act
We celebrated the 25th anniversary of the Orphan Drug Act yesterday with a breakout session in the morning and a press conference in the afternoon. Speakers included the legislators who championed the bill 25 years ago and companies who are now, thanks to the Act, able to make treatments that change people's lives. The Orphan Drug Act celebrated its 25th birthday on January 4, 2008. The Act provides developers with the exclusive right to market an orphan drug for that indication for seven years from the date of FDA approval. The term orphan drug refers to a drug or biologic that treats a rare disease or condition. According to the National Organization for Rare Disorders (NORD) since the signing of the Orphan Drug Act more than 300 new drugs have been approved for treatment of orphan diseases, that's an average of 11 new drugs a year. In the 10 years preceding the approval of the Orphan Drug Act only 10 new therapies had been developed. The significance of the Orphan Drug Act came to life at the press conference. Dr. Tim Cote from FDA said that "Statistics are people with the tears wiped away." His point was well-made by three brave patients with orphan diseases who stood up to tell heart-warming stories of how the Orphan Drug Act changed their lives. Including, 17-year-old John Adams, Jr. (who has a rare condition called PKU) after a handshake and a photo op with Gov. Schwarzenneger, took questions from reporters.