Congressmen Introduce Bill to Prevent Generic Drug Delays

Congressmen Kurt Schrader (D-OR) and Earl L. Carter (R-GA) have introduced legislation aimed at keeping drug prices down by increasing competition in the generic drug market. The Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act (HR 938) would aim to prevent the first generic product makers of a class of drugs “parking” their exclusivity awards and thus blocking subsequent generic approvals.

Under the BLOCKING Act, if a second generic drug application is blocked from gaining approval solely due to a first generic drug manufacturer parking their exclusivity at the tentative approval stage, then the 180-day exclusivity period immediately begins to run, preventing limitless delays for other generics to come to the market, according to the lawmakers. “This legislation mirrors a proposal to “speed development of more affordable generics to spur competition” that was included in the administration’s FY19 budget proposal,” they say.