On October 1, Rep. Frank Pallone (D-NJ) introduced a bill that would provide dietary supplement manufacturers with economic incentives to conduct clinical research on their products. The legislation would give a company 10 years of exclusivity for a health claim for any product that has an FDA-approved clinical study. The Foundation for Innovation in Medicine is a major supporter of the bill. However, some critics believe that the 10 year period of exclusivity is too long. They also fear that the approval process could be too arbitrary. On the other hand, the act would allow a company to submit a petition for a similar product or claim before the 10 year marker if they can show "greater effectiveness, greater safety or otherwise a major contribution to patient care." The bill also contains a provision for small businesses that would allow them to pool their resources in conducting clinical research and to share health claim exclusivity, upon approval of their petition.
The Tan Sheet, October 4, 1999.
