AVDL - Senators introduce legislation to eliminate drug company loophole that delays competition

Sens. Maggie Hassan (D-N.H.) and Mike Braun (R-Ind.) have reintroduced legislation that aims to end a loophole that at least one pharma company has used to block competition for its drugs.

The bill, the Prescription Drug Competition Act, would allow the US FDA to approve drugs without a stay if the only issue is related to a Risk Evaluation and Mitigation Strategy (REMS) program patent.

The lawmakers highlighted that Jazz Pharmceuticals ( NASDAQ: JAZZ ) patented a REMS program for its excessive daytime sleepiness drug Xywav and Xyrem (sodium oxybate) as a way to delay competition.

One of those competitors is Avadel Pharmaceuticals' ( NASDAQ: AVDL ) Lumryz, an extended-release formulation of sodium oxybate.

In February, Jazz ( JAZZ ) lost an appeal on a federal court decision ordering it to delist the REMS patent related to sodium oxybate .

The proposed legislation would allow the FDA to immediately approve drugs – and eliminate the standard 30-month approval stay – if the only barrier to approval is a REMS patent.

The bill also provides that should a drug company sue to stop a generic drug over a REMS patent, the lawsuit may continue, but it cannot stop the sale of the generic.

Earlier Thursday, Avadel ( AVDL ) said it has submitted an amendment asking the FDA for final approval of Lumryz .

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