Ruling Against FDA in Prepopik Case Could Benefit Other Drugs


A recent ruling on FDA exclusivity policy in favor of Ferring Pharmaceuticals Inc.'s colon cleansing drug Prepopik is likely to also benefit other drugs that were denied exclusivity rights under the same policy.

In the Sept. 9 ruling, Judge Rudolph Contreras of the U.S. District Court for the District of Columbia slammed the agency’s decision to deny Prepopik five years of new chemical entity (NCE) exclusivity, finding it was arbitrary and capricious. He ordered the FDA to reconsider its Prepopik decision.

What does Contreras’ ruling kicking back the matter to the FDA mean? Well, according to Terry G. Mahn, an attorney with Fish & Richardson P.C. in Washington and an expert in patent and exclusivity matters, it means that the FDA will have to award Prepopik five years of NCE exclusivity.

And if Prepopik is awarded that exclusivity, which provides valuable extra time on the market before the drug has to face generic competition, it also means the FDA’s going to have to reconsider similar NCE denials it made. That would include decisions it made to deny NCE exclusivity for Gilead Sciences Inc.’s AIDS drug Stribild and Bayer HealthCare Pharmaceuticals Inc.'s contraceptive Natazia.

Michele Rest, a spokesperson for Gilead, told me Sept. 12 that Gilead’s aware of the ruling and the company is considering the impact of the court’s decision on Stribild.

Under FDA policy that was operational until October 2014, the agency awarded NCE rights based on the order in which drug applications were approved. Per that policy, the FDA interpreted the five-year exclusivity provision to mean that only drug products containing no previously approved drug substances were eligible for exclusivity.

Because Prepopik, a combination drug with multiple active ingredients, contained some active ingredients that had previously been approved by the FDA, the agency denied Ferring's request for exclusivity for Prepopik despite the fact that one of its active ingredients hadn’t received prior agency approval. Stribild and Natazia, like Prepopik, are combination drugs that contain at least one active ingredient that the FDA hadn’t approved before, and the FDA similarly rejected their bids for five years of NCE exclusivity.

Stay tuned to see how the FDA implements Contreras’ ruling. . .

A copy of the opinion is at

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