NDI Guidance Could Drive Amarin's Gambit To Block Some Omega-3 Imports
Amarin's argument would swing on a finding by FDA that synthetics of omega-3s are not dietary ingredients. With such an FDA determination, a fair trade complaint to International Trade Commission about imports of omega-3 ingredients similar to the active ingredient in Amarin's Rx Vascepa theoretically would not be asking ITC to interpret FDA regulations by investigating imports of substances which FDA has not identified as noncompliant with its regulations.
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"In a bid to have the right to purchase high-purity omega-3 supplements stripped from US consumers, Amarin attempted to circumvent the jurisdiction granted by Congress" to FDA, says Medical Research Collaborative in petition. The author also has reviewed Amarin's business results and has been critical of its stability.
As Amarin did in complaint to ITC for a fair trade investigation and appeal to Federal Circuit. it framed its petition for a writ of certiorari to Supreme Court as a compliant pharma firm that invested in research for approval of a drug asking federal agencies to enforce laws to stem competition from products it claims are labeled as supplements but should be deemed unapproved drugs.
In comments on VMS industry oversight, PhRMA recommends FDA adhere to clear regulations that determine whether substances are eligible for use as dietary ingredients. DSHEA makes clear that some dietary ingredients are not eligible for use VMS products.