Ferring Petition: FDA Interpreted Hatch-Waxman Wrong

Ferring Pharmaceuticals is petitioning the FDA for five-year exclusivity on its colonoscopy prep drug Prepopik. The agency erroneously granted just three-years of exclusivity because two of the drug’s three active ingredients were already approved, the company argues. Failure to reward Prepopik (citric acid/magnesium oxide/sodium picosulfate) five-year exclusivity is contrary to the intent of the Hatch-Waxman amendments to the 1938 FD&C Act, which intended to reward innovators that develop drug products containing novel active ingredients.
Washington Drug Letter