REMS/Sample Acquisition Remedies

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.

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