Rare Disease Bill Would Uphold FDA’s Use of Law, Avert Suits (1)

Rare disease drugmakers would retain their special status when pursuing treatments especially for children under legislation scheduled to be marked up by a Senate panel next week.

The legislation aims to head off future lawsuits like the one Catalyst Pharmaceuticals Inc. won last year, granting them exclusive rights to market a drug to treat a rare disease.

Sen. Tammy Baldwin’s (D-Wis.) Retaining Access and Restoring Exclusivity Act, or RARE, Act (S. 1214) is one of a package of drug pricing bills the Senate Health, Education, Labor and Pensions will consider May 2. Baldwin’s bill aims to solidify incentives that ...