REMS/Sample Acquisition Remedies | Association for Accessible Medicines

REMS/Sample Acquisition Remedies

$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.

Pass the CREATES Act to End Manipulative Practices That Cost Our Patients Billions

Since Apotex’s inception over 40 years ago, our company has focused on a sole purpose: improving access to affordable, innovative and high-quality medications. Over the years, we have seen the generics industry weather a number of challenges caused by legislative and regulatory changes in the markets in which we operate. The industry has also benefited from a number of positive changes that improve the ability of companies like Apotex to bring affordable generics and biosimilars to market – saving patients billions of dollars.

Transparency an Important Step in Ending the Shenanigans

Congress Signals Intention to Pass Legislation Needed to End Games

WASHINGTON DC (May 17, 2018) – Today, the Food and Drug Administration (FDA) for the first time publicly identified brand-name pharmaceutical companies who abuse FDA’s safety programs or erect their own restricted distribution systems without an FDA mandate to delay competition from generic and biosimilar manufacturers. These anti-competitive tactics artificially extend the monopolies on blockbuster brand drugs and keep drug prices high for millions of patients.

Generic and Biosimilar Competition Is Cornerstone of President Trump’s Blueprint to Lower Drug Prices for American Patients

Administration’s Plan Embraces Getting More Generic and Biosimilar Medicines to Patients

WASHINGTON DC (May 11, 2018) – In President Trump’s remarks today at the White House, he made clear the essential role that generic and biosimilar medicines play in containing prescription drug costs for patients.

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