REMS/Sample Acquisition Remedies | Association for Accessible Medicines

REMS/Sample Acquisition Remedies

Access to Samples (REMS/CREATES Act)

Current FDA-mandated Risk Evaluation and Mitigation Strategies (REMS) are designed to serve a clear public health purpose – that of ensuring that the benefits of a drug outweigh its safety risks. AAM and the Biosimilars Council are working to strengthen REMS programs to ensure that they are properly used to protect patients and cannot be used to promote anti-competitive business practices.

AAM Statement: 2019 Energy and Commerce Health Subcommittee Markup

WASHINGTON, DC (March 27, 2019) – The generic and biosimilar industry greatly appreciates the efforts of the Energy and Commerce Health Subcommittee to pass the CREATES Act and advance this bipartisan market-based solution to end abuse of FDA’s safety programs. Today’s markup, unfortunately, represents one step forward and two steps back for patients who want competition to lower drug prices.

Statement from the Association for Accessible Medicines on the Introduction of the CREATES Act

WASHINGTON, DC (February 8, 2019) — The high price of prescription drugs is the number one domestic policy issue in this country, and the CREATES Act is a bipartisan solution that will address some of the anticompetitive tactics that drive prices ever-higher. CREATES has been studied, debated and voted out of committee. Now it is time for the full Congress to take up and pass this critical legislation.

$13.4 Billion a Year! Brand “Shenanigans” Are Costing Patients More Than Ever

When a brand-name prescription drug’s market exclusivity (its monopoly) and patents expire, generic and biosimilar medicines become available, the savings begin and patients win. That’s how the system is supposed to work. However, brand-name pharmaceutical companies have increasingly abused FDA’s safety programs (Risk Evaluation and Mitigation Strategies, or REMS) and other manufacturer-imposed restricted distribution of samples to delay competition and impede patient access to more affordable prescription drugs.

AAM Statement on Senate Judiciary Committee Vote on CREATES Act

WASHINGTON DC (June 14, 2018) – Today, the Senate Judiciary Committee, on a strong bipartisan basis, has taken a critical first step toward making real progress on the problem that U.S. patients care the most about: high drug prices. The full Senate and the House should follow the Judiciary Committee’s lead and pass a strong CREATES Act so President Trump can sign into law this important legislation that will help fulfill the goals of his American Patients First plan.

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