Call it a coincidence, but for the second time this month, a drugmaker is taking the rare step of challenging the FDA over its decisionmaking for marketing exclusivity. Specifically, Ferring Pharmaceuticals has filed a citizen’s petition asking the agency to change its approach for granting exclusivity to combination medications. At stake is the opportunity to wring more revenue out of its Prepopik solution for colonoscopy preparation, which was approved last July. The petition was filed shortly after Gilead Sciences filed a very similar petition concerning exclusivity for its Stribild AIDS treatment, a fixed-dose combination drug that was also approved last summer. Ferring argues that five years of exclusivity is warranted because Prepopik contains an active ingredient, sodium picosulfate, that has never before been a component of an approved new drug application, unlike two other ingredients. But the FDA has regularly interpreted the law to say that drugmakers do not receive five years of exclusivity unless all ingredients are new. In its own petition, Gilead (GILD) made a similar argument because two of four active ingredients in Stribild are new. But as we noted recently, the FDA currently awards only three years of exclusivity if a combination treatment contains a previously approved ingredient, and if a drugmaker conducted new clinical studies that were essential to approval. The arguments have potentially significant implications if more drugmakers first seek approval for combination medications with one or more new active ingredients. Most of the time, though, drugmakers try to win approval of a new single-ingredient drug in order to secure five years of exclusivity and then seek FDA approval of a fixed-dose combination including that drug.
