Non-partisan CBO gives thumbs up to CREATES Act

A review of pending legislation from the non-partisan Congressional Budget Office (CBO) says the bill would allow generics to hit the shelves more quickly and enable the US government to spend less on prescription drugs.

The long-proposed Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, which is currently awaiting a vote in the US Senate, aims to facilitate access by biosimilar and generic drug applicants to reference samples needed for testing and approval.

The US Food and Drug Administration, led by Commissioner Scott Gottlieb, has in recent months increased its rhetoric around tackling so-called REMS abuse, where licence holders use the procedures of the Risk Evaluation and Mitigation Strategy (REMS) to slow down competition from generics.