Entries by Grant Kerber

Rare Disease Acts of 2002

On November 7, 2002, the White House announced that President Bush signed into law the Rare Diseases Act (H.R. 4013) and the Rare Diseases Orphan Product Development Act (H.R. 4014). Originally introduced in August 2001 by Senators Edward Kennedy (D-MA) and Orrin Hatch (R-UT)  the Rare Diseases Act of 2001 (S. 1379) was later split into […]


Department of Health and Human Services, OFFICE OF INSPECTOR GENERAL  MAY 2001 PURPOSE:  The purpose of this inspection was to assess the implementation of the Orphan Drug Act of 1983 and its impact on industry and patients. BACKGROUND Congress passed the Orphan Drug Act of 1983 to stimulate the development of drugs for rare diseases. A rare disease […]

Orphan Drug Act: Background and Proposed Legislation in the 107th Congress

Congressional Research Service (CRS) Report for Congress, July 2001 The Orphan Drug Act (P.L. 97-414) was signed into law on January 4, 1983. The Act provides incentives for pharmaceutical manufacturers to develop drugs, biotechnology products, and medical devices for the treatment of rare diseases and conditions. These products are commonly referred to as orphan products. Incentives for orphan product development […]

Prescription Drug User Fee Act (PDUFA) of 1992

In 1992, Congress first enacted the Prescription Drug User Fee Act (PDUFA) which collects fees from drug manufacturers. The FDA uses the additional revenue stream to hire more staff with the goals of: More efficient and timely review of license applications, and Increase their medical and scientific expertise. The law was authorized for five years and has been reauthorized […]

Orphan Drug Act of 1983

111TH CONGRESS 1ST SESSION H. R. 5238 IN THE HOUSE OF REPRESENTATIVES December 15, 1981 Mr. Waxman introduced the following bill; which was referred to the Committee on Energy and Commerce