Drugs

FDA Wants to Change Generic Drug Exclusivity: Attorney

A legislative proposal distributed as part of FDA’s budget request documents intends to “amend the 180-day exclusivity provisions to encourage timely marketing of first generics.” However, attorney Kurt Karst (Hyman, Phelps & McNamara) writes in his firm’s FDA Law Blog, the result would be the opposite of what the agency is looking for.

Karst says FDA wants to change the statutory provisions that govern the 180-day patent challenge exclusivity provisions to specify that it can approve subsequent applications unless a first applicant begins commercial marketing of the drug, at which point approval of subsequent applications would be blocked by 180 days, ensuring that exclusivity actually lasts 180 days (from the date of first commercial marketing by a first applicant until 180 days later) rather than for multiple years as can occur under current law.

The proposal would replace the current ANDA Paragraph IV exclusivity system with one modeled after the Competitive Generic Therapy regime created by the FDA Reauthorization Act of 2017 for drugs for which there is inadequate generic competition and for which there are no unexpired patents or exclusivities listed in the Orange Book at the time of original submission of an ANDA, Karst writes.

The attorney says the Competitive Generic Therapy regime has worked quite well for drugs with inadequate generic competition but using it as a blueprint for the approval of generic versions of branded drugs with “dense patent thickets” makes no sense.

He notes that patent challenges often result in settlements that allow for a generic launch before patent expiration. But under a competitive therapy approach that would trigger exclusivity only upon launch, which may occur years after ANDA approval, by the time launch occurs and exclusivity is triggered, there will be no further approvals to which the exclusivity would apply.

“Perhaps this is FDA’s way of trying to limit patent settlements,” Karst says. “But if you limit a generic drug manufacturer’s ability to settle cases, that manufacturer does not settle fewer cases, it submits fewer Paragraph IV ANDAs. And fewer ANDAs means less, not more, generic drug competition.”

Karst includes a proposal he calls the “First Applicant Prime” for FDA to consider as an alternative approach.

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