Regulatory Focus™ > News Articles > House Bill Would Incentivize Drugmakers to 'Repurpose' Drugs for Rare Diseases

House Bill Would Incentivize Drugmakers to 'Repurpose' Drugs for Rare Diseases

Posted 02 March 2017 | By Michael Mezher 

House Bill Would Incentivize Drugmakers to 'Repurpose' Drugs for Rare Diseases

Rep. Gus Bilirakis (R-FL) on Monday reintroduced a bill that would grant drugmakers an additional six months exclusivity for repurposing already-approved drugs to treat rare diseases.

The bill, known as the Orphan Product Extensions Now Accelerating Cures and Treatments (OPEN) Act, was initially included in the 21st Century Cures Act, but was removed before it was signed into law last year.

The additional exclusivity for new orphan indications under the OPEN Act would also stack with exclusivity incentives for qualified infectious disease products and for products that are studied in pediatric populations under the Generating Antibiotic Incentives Now Act and Best Pharmaceuticals for Children Act.

"The OPEN Act would help make sure those suffering from a rare condition can finally find safe, effective, and affordable medication," Bilirakis said.

The bill was introduced in the House with three other Republicans and two Democrats signed on as cosponsors, and has received support from more than 150 rare disease organizations.

Both Bilirakis and the rare disease community say they believe the act will help lower the cost of treating rare diseases by getting drugs with "mainstream prices" approved for orphan indications.

However, the bill comes at a time when incentives for orphan drugs are under increased scrutiny as more orphan drugs are winning approval and entering the market with high prices.

Last month, Sen. Charles Grassley (R-IA) launched an inquiry into possible abuses of the Orphan Drug Act.

"I'm interested in learning whether the unanticipated uses of the provisions are contributing to high prices for commonly used drugs," Grassley said in an email to Focus.


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