6 December 2016 - The Generic Pharmaceutical Association strongly supports the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act introduced earlier this year by Senators Grassley, Lee, Leahy, and Klobuchar and applauds their efforts to highlight this issue during the Senate consideration of the 21st Century CURES bill.
The CREATES Act is a bipartisan solution to curb instances of brand drug companies abusing FDA patient safety programs, such as Risk Evaluation and Mitigation Strategies to block generic competition. Misuse of REMS and REMS-like programs carries real costs for patients and payers. A Matrix Global Advisors analysis shows $5.4 billion in additional pharmaceutical costs per year result from these brand company tactics.
The bill is supported by a wide range of health care groups representing seniors, consumers, physicians, pharmacists, hospitals, insurers, and others who recognise that generic drugs are essential for increasing patient savings and expanding access to more affordable medicines.