Stakeholders Support Legislation That Will Stop Brand Drug Companies From Blocking Access to Affordable Generic Drugs
WASHINGTON, DC (April 27, 2017) – The Association for Accessible Medicines (AAM) and its Biosimilars Council wholeheartedly support bipartisan legislation introduced in the House and Senate today to increase competition for prescription drugs and lower the cost of treatments for patients in the U.S.
The bill remedies a situation where some branded drug companies block generic companies from developing generic and biosimilar alternatives for patients. According to a January 2017 Health and Human Services (HHS) Office of Inspector General (OIG) report, Revlimid, a drug to treat certain blood cancers, is the second highest drug spend in Medicare Part D's catastrophic coverage program, costing taxpayers more than $1.7 billion per year. Generic manufacturers have been thwarted in their attempts to bring an equally safe and effective version of this drug to market since 2013.
“It’s time to tear down the walls blocking access to affordable generic and biosimilar medicines, and this legislation goes a long way toward achieving that,” said Chester “Chip” Davis, Jr., President and CEO of AAM.
The “Creating and Restoring Equal Access to Equivalent Samples Act of 2017” or the “CREATES Act” was introduced in the Senate by Senators Patrick Leahy (D-VT), Chuck Grassley (R-IA), Mike Lee (R-UT), Amy Klobuchar (D-MN), Tom Cotton (R-AR), Sheldon Whitehouse (D-RI), John McCain (R-AZ), Richard Blumenthal (D-CT), Susan Collins (R-ME), Claire McCaskill (D-MO), Dick Durbin (D-IL), and Diane Feinstein (D-CA). The CREATES Act was introduced in the House by Representatives Tom Marino (R-PA) and David Cicilline (D-RI). Specifically, the legislation addresses the anticompetitive behavior of certain brand drug manufacturers that use Risk Evaluation and Mitigation Strategy (REMS) programs to deny the product samples necessary for generic and biosimilar development.
The Congressional Budget Office (CBO) has estimated that similar legislation would save the government more than $3 billion in direct savings over 10 years.
“Momentum is building for smart reform that unleashes the full potential of the emerging biosimilars market,” said Bruce Leicher, Chair of the Biosimilars Council, a Division of AAM.
AAM and the Council also joined a diverse coalition of stakeholders in support of the CREATES Act in a letter to the bill’s sponsors, released today. The organizations said the bill “would provide a clear solution to abusive, anticompetitive business practices that increase costs to the American health care system by impeding patient access to generic and biosimilar medicines.” The full letter can be viewed here.
The letter was signed by leading health care organizations and consumer groups, including:
Academy of Managed Care Pharmacy
America's Health Insurance Plans (AHIP)
American College of Physicians
American Society of Health System Pharmacists
Association for Accessible Medicines and The Biosimilars Council
BlueCross BlueShield Association
Campaign for Sustainable Rx Pricing
Coalition to Reduce Spending
Frontiers of Freedom
Healthcare Supply Chain Association
Pharmaceutical Care Management Association (PCMA)
Premier healthcare alliance
Public Sector HealthCare Roundtable
Across the health care spectrum, stakeholders, Members of Congress, current and former government officials are calling out Big Pharma for their tactics that deny patients access to affordable generic alternatives. Find out “What They Are Saying” about Big Pharma blocking access to generic samples here.
One of the nation’s leading patient groups, the National Health Council (NHC), recently endorsed policies to stop brand drug companies from abusing REMS programs.
The HHS Office of Inspector General’s 2017 report, “High-Price Drugs are Increasing Federal Payments for Medicare Part D Catastrophic Coverage,” can be accessed here.
AAM is driven by the belief that access to safe, quality, effective medicine has a tremendous impact on a person’s life and the world around them. Generic and biosimilar medicines improve people’s lives, improving society and the economy in turn. AAM represents the manufacturers and distributors of finished generic pharmaceuticals and biosimilars, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals are 89 percent of prescriptions dispensed in the U.S. but only 27 percent of total drug spending. Additional information is available at www.accessiblemeds.org.
About the Biosimilars Council
The Biosimilars Council, a division of the Association for Accessible Medicines (AAM), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available at www.biosimilarscouncil.org.