Senators Revive Bill to Close REMS Patent Loophole

A bill that would prevent pharma companies from blocking generic competition by patenting their drugs’ Risk Evaluation and Mitigation Strategy (REMS) programs is making a return appearance in the 118th Congress.

The reintroduction of the Prescription Drug Competition Act was inspired by recent reports about Jazz Pharmaceuticals patenting its narcolepsy drug’s REMS as a way to keep competitors (generic and otherwise) out of the market, said Senator Maggie Hassan (D-N.H.), a member of the Senate Health, Education, Labor, and Pensions (HELP) Committee.

The bill — also introduced by HELP committee member Sen. Mike Braun (R-Ind.) — would enable the FDA to immediately approve drugs instead of waiting out the normal 30-month approval stay if the only barrier to approval is a REMS patent.

In addition, the bill would stop pharmaceutical companies from abusing the patent and court system by ensuring that if a drug company sues to stop a generic over a REMS patent, the lawsuit may go on but it cannot stop the sale of the generic drug.