Competition is what makes markets work. It's what keeps prices down. So when brand pharmaceutical companies tilt the playing field, drugs become less affordable and less accessible. The bipartisan CREATES Act (S. 974/H.R. 2212) would level the field, saving patients billions. Share this video and let's team up to tackle high drug costs for patients! #stopREMSAbuse
Competition is what makes markets work. It's what keeps prices down. So when brand pharmaceutical companies tilt the playing field, drugs become less affordable and less accessible. The bipartisan CREATES Act (S. 340/ H.R. 965) would level the field, saving patients billions.
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WASHINGTON, DC (AUGUST 1, 2017) – The Association for Accessible Medicines (AAM) urges the United States Senate to consider and pass the FDA Reauthorization Act of 2017 (FDARA) as soon as possible. We are encouraged by Majority Leader Mitch McConnell’s (R-KY) remarks earlier today that he wants his colleagues to complete action on the FDARA before the Senate begins its August recess.
Since it was created in 2007, the Food & Drug Administration’s (FDA’s) Risk Evaluation and Mitigation Strategies (REMS) has been an important tool for patient safety by ensuring that the benefits of a drug or biological product outweigh its safety risks. FDA-mandated REMS serve a clear public health purpose, yet some brand drug companies have been misusing this patient safety program and other restricted access drug programs to extend market monopolies, intentionally limiting patient access to biosimilars.
Generic and biosimilar medicines are saving families money and holding down government costs. The Association for Accessible Medicines (AAM), formerly known as the Generic Pharmaceutical Association, advocates for policies that ensure real competition not half-measures or window dressing. When we stop some brand drug companies from blocking or delaying competition from safe, effective and more affordable alternatives, patients and our healthcare system win.
According to FDA estimates, generics are 80%-85% less expensive than their brand-name drug equivalents. Competition and a patient-centered orientation are what make generics and biosimilars the solution that helps people live their lives, their way. The Association for Accessible Medicines and its members give millions of Americans what they need to need to live healthier, more productive lives.
Share this video to show your support and use the hashtag #medswithinreach.
Patient safety is our industry’s top priority. FDA-mandated Patient safety programs are the guardrails of our industry. These programs protect patients and the trust they put in medicines by ensuring the benefits of medications outweigh potential risks. Unfortunately, some brand companies have engaged in tactics that abuse these patient safety programs.
Alex Brill
June 2017
The sustained concern over high drug prices has led policymakers to identify undue barriers to generic entry as a contributing factor. One such barrier is brand drug manufacturers’ misuse of Risk Evaluation and Mitigation Strategy (REMS) and other restricted access programs to block generic competition. This study explains how REMS programs and other strategies are misused and estimates the parameters of the problem in terms of the number of drugs potentially affected and their total sales.
April 27, 2017
The Honorable Chuck Grassley Chairman
The Honorable Patrick Leahy
The Honorable Tom Marino
The Honorable David Cicilline
