Senate bill to streamline generic drug approval reintroduced

U.S. Senators Rand Paul (R-KY) and Maggie Hassan (D-NH) reintroduced a bill to simplify the approval of generic drugs on Tuesday.

The bill named Increasing Transparency in Generic Drug Applications Act, “will help low-cost generics get to American consumers faster,” Paul said.

“Our bipartisan bill will cut unnecessary red tape to help get low-cost generic medications onto the market and into the hands of patients more quickly,” Hassan added.

The legislation cleared the House and Senate HELP committees last year with bipartisan support.

The FDA currently requires certain generic drugmakers to demonstrate that the concentration of the active and inactive ingredients in their drugs are similar to those of the brand name drug.

However, the approval process can drag when the concentration of inactive ingredient differ because the FDA cannot specify the error.

If passed, the new legislation would require the FDA to clearly identify the specific differences, helping generic drugmakers bring their products to the market faster.

Generic drug manufacturers: Teva Pharmaceutical Industries (NYSE:TEVA), Viatris (NASDAQ:VTRS), Amphastar (NASDAQ:AMPH), Amneal Pharmaceuticals (NYSE:AMRX), Lannett Company (LCI)

Read: Seeking Alpha contributor Nathan Aisenstadt issued a Buy rating on Teva (TEVA) in February, arguing that in 2023 the company could "regain its leading position in therapeutic areas such as CNS and respiratory diseases.”