REMS/Sample Acquisition Remedies | Association for Accessible Medicines
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REMS/Sample Acquisition Remedies

Statement on Timing of FDA User Fee Reauthorization (FDARA)

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.

Biosimilars: Breaking Down Barriers to Patient Access (REMS)

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.

Protect & Expand Competition

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.

Generic Drug Prices vs. Brand Drug Prices

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.

Bill to Lower Drug Prices Gains Bipartisan Momentum in the House and Senate

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.

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