One bill in the House of Representatives is named The Rare Diseases Act of 2002 (H.R. 4013). It will establish an official Office of Rare Diseases at the NIH. The Office will promote and coordinate research on rare disorders, and will create academic Centers of Excellence for research on these conditions. The NIH Office of Rare Desease would receive $24 million per year for this program.

The second bill in the House is named The Rare Disease Orphan Product Development Act of 2002 (H.R. 4014). The law would provide $25 million per year for the FDA’s Orphan Products Research Grant Program, which supports clinical trials of new orphan drugs, diagnostics, medical devices and medical foods. This program received only $12 million from Congress this year, which is less than the funds appropriated for these research grants in 1995. To date, 27 new products (24 orphan drugs and 3 medical devices) have been developed, and are currently on the American market because academic scientists and small companies received grants from this program to support their clinical trials.