FDA defiant on orphan exclusivity rules even after court judgement

By Fiona Barry

- Last updated on GMT

A circuit court ruled the FDA must award Depomed's orphan drug Gralise marketing exclusivity. (Image: Tori Rector)
A circuit court ruled the FDA must award Depomed's orphan drug Gralise marketing exclusivity. (Image: Tori Rector)

Related tags: European medicines agency, Fda

The US FDA says it will stick to its policy on orphan drug exclusivity despite a conflicting court ruling.

A statement from the US Food and Drug Administration said it will continue to deny marketing exclusivity to orphan drugs unless companies prove clinical superiority to approved rivals.

This is despite an apparently contradictory D.C. Circuit ruling in September 2014, which found against the US Department of Health and Human Services and granted marketing exclusivity to Depomed’s orphan drug Gralise for the treatment of post-3 herpetic neuralgia (Depomed v. HHS et al., Civil Action No. 12-1592 (KBJ)).

The FDA opposed awarding exclusivity to Gralise because it considered Pfizer’s drug Neurontin identical. Gralise is “the same drug as Neurontin, because it contains the same active moiety (gabapentin), was approved for the same use (post-herpetic neuralgia), and was not demonstrated to be clinically superior to Neurontin,​” it said.

Neurontin was approved for the market at the time of the case, and did not have orphan drug designation.

There may be a phase two to the FDA's strategy...

Despite these reservations the FDA has awarded Depomed seven years’ marketing exclusivity for Gralise but the agency said “given the limited terms of the court’s decision​,” it will not do the same with other orphan drugs.

The regulator will continue to “require the sponsor of a designated drug that is the ‘same’ as a previously approved drug to demonstrate that its drug is ‘clinically superior’”​ to be eligible for orphan-drug exclusivity.

An expert's take

There are several theories about what the FDA’s strategy is,​” Steven Grossman, President of health policy consultancy HPS Group, told us.

One possibility is they’re inviting a [legal] appeal in the hope that they can overturn the precedent.​”

A second, he said, is that the FDA believes it can interpret the ruling to apply only to the plaintiff in this case, Depomed. To do this, “they have to have had the Justice Department’s permission,​” said Grossman.

If they want to see how long they can run [exclusivity rules] the way they think they ought to, by saying it’s a precedent of one and not many and the Justice Department says they can, there’s no one who can take them to court because the plaintiff won.

The third possibility is they’ve calculated how rarely this case is likely to come up and decided that for another plaintiff to emerge with a similar situation and a deep enough set of pockets to want to sue [is unlikely].​”

But the FDA’s options are not limited to bowing to the ruling or sticking to its guns, said Grossman.

There’s also a perception that there may be a phase two to this strategy.​” He speculated that the FDA could have a longer-term plan around marketing rules that it could announce at a later date.

Drug companies themselves have remained quiet on the issue. Neurontin’s maker, Pfizer, declined to comment at the time of publishing on whether it stands with the FDA’s view on exclusivity and if it is considering future litigation.

Grossman noted the “absence of noise​” from big pharma on the issue, at least publicly. This may be, he said, because “nobody really knows where they stand on this because it’s very hard to look at your portfolio and say if two years from now I’m going to be in either the innovators’ position or the [other] position.​”

Related topics: Markets & Regulations, Regulations

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