Senate Leaders Offer Bipartisan Plan to Lower Drug Costs, Speed Patient Access to Generic Medicines

CREATES Act Increases Generic Competition, Offered as Amendment to CURES

PRESS RELEASE

WASHINGTON, DC (Dec. 6, 2016) — The Generic Pharmaceutical Association (GPhA) strongly supports the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act introduced earlier this year by Senators Grassley (R-IA), Lee (R-UT), Leahy (D-VT), and Klobuchar (D-MN) 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 Food and Drug Administration (FDA) patient safety programs, such as Risk Evaluation and Mitigation Strategies (REMS) 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 recognize that generic drugs are essential for increasing patient savings and expanding access to more affordable medicines.

The CREATES Act is a smart, bipartisan approach that prevents some brand companies from gaming the system to block consumer access to safe, effective and lower-cost generic and biosimilar medicines.

The continued leadership of Senators Grassley (R-IA), Lee (R-UT), Leahy (D-VT), and Klobuchar (D-MN) on this important issue is critical to our shared goal — ensuring that patients have greater access to safe, effective, affordable generic and biosimilar drugs. The CREATES Act is one way that policymakers can increase generic and biosimilar competition today and help address the concerns about rising brand drug costs shared by millions of patients and payors.

Read the letter to sponsors of the CREATES Act here.

Visit www.stopREMSabuse.com for more information.