Nutraceutical Research and Education Act introduced on House floor
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.
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