CREATES Act out, lobbyists say

The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act will not be included in the pending omnibus budget bill, anonymous lobbyists for the pharmaceutical industry told BioCentury Wednesday. Although the bill has bipartisan support and is aligned with Trump administration policies, a combination of lobbying muscle and political calculation have scuttled efforts to have it included in the omnibus bill.

CREATES seeks to prevent branded drug manufacturers from using REMS to avoid selling drug samples that are needed to develop generic versions. It would also prevent branded drug companies from using REMS distribution systems to block generic competition...