Sens. Maggie Hassan (D-N.H.) and Mike Braun (R-Ind.) on Wednesday reintroduced legislation intended to close a loophole that drug companies can exploit to block competition, including from lower-cost generic drugs.
Federal regulators will sometimes require that drug manufacturers have a Risk Evaluation and Mitigation Strategy (REMS) program for potentially dangerous medications.
According to the Food and Drug Administration (FDA), REMS are not designed to mitigate all the adverse events of a medication, but are focused on preventing, monitoring or managing a specific risk — for instance, requiring training for doctors to prescribe the drug.
But some pharmaceutical companies patent their REMS program as a way to delay or block alternate versions of the medication from entering the market, in order to stop competition and keep prices high.
The lawmakers cited a report published Monday in the New York Times detailing how Jazz Pharmaceuticals used the strategy of patenting its REMS program for a narcolepsy drug in order to block the release of a similar drug from a competitor.
“Our bipartisan bill would finally close this absurd loophole that big pharmaceutical companies, such as Jazz, can use to slow down the release of better, cheaper drugs in order to line their own pockets,” Hassan said in a statement.
“For too long, Big Pharma has artificially inflated drug prices at the expense of patients, but it doesn’t need to be this way. I will continue working across the aisle to take on Big Pharma and lower health care costs for all Americans.”
The Prescription Drug Competition Act would allow the FDA to immediately approve drugs — instead of the normal 30-month approval stay — if the only barrier to approval is a REMS patent.
Additionally, if a drug company sues to stop a generic over a REMS patent, the bill would allow the sale of the generic drug to go forward while the lawsuit proceeds.
