REMS/Sample Acquisition Remedies

2017 AAM Annual Report

2017 Was Epic

The landscape around us looks much different today than it did just one year ago. As our industry changes within the evolving pharmaceutical ecosystem, we must speak with one voice to drive home the message that a robust generic drug and biosimilars marketplace is necessary to sustain affordable health care.

AAM White Paper: Ensuring the Future of Accessible Medicines in the U.S.

Patient health and well-being depends on the uninterrupted availability of lower-cost generic and biosimilar medicines. Moreover, as patients live longer the importance of a robust and sustainable generic and biosimilar medicines industry becomes only that much more important. Policymakers must act quickly to ensure continued saving and market-based competition, as well as prevent shortages, for future availability of affordable medicines. This requires:

Help Pass the CREATES Act

Anticompetitive practices prevent patients from accessing the generic and biosimilar medicines they need.

Congress is currently considering a fix, the Creating and Restoring Equal Access to Equivalent Samples (“CREATES”) Act. Encourage your members of Congress to pass this important bill that will bring down costs and increase patient access to life-saving medicines. 

Watch this CBS News story that explains the challenge facing so many Americans, like cancer patient, Pam Holt. You, like Pam, can make a difference. 

Dear Mr. President

“To speed access to breakthrough cures and affordable generic drugs, last year the FDA approved more new and generic drugs and medical devices than ever before in our history.”

-Donald Trump, State of the Union, January 30, 2018

In his first State of the Union, President Donald Trump stressed the importance of approving safe and affordable generic drugs.

#EndtheShenanigans, Says Gottlieb

Dr. Scott Gottlieb, Commissioner of Food and Drugs, has adopted a bold stance on behalf of patient access to affordable medicines. In particular, he is targeting REMS abuse — by which some bad actors prevent generic firms from purchasing the doses of a branded drug that they need to run their studies — for the way it undermines the sustainable competition necessary for FDA-approved generic drugs and biosimilars to reach patients.

AAM Tells Senate: Generics Are Solution to High Drug Prices

On October 17, 2017, the Senate Health, Education, Labor and Pensions Committee, under the leadership of Senators Lamar Alexander (R-TN) and Patty Murray (D-WA), convened a hearing to explore why drug prices are so high. The committee asked trade associations representing different parts of the prescription drug supply chain – manufacturers, wholesalers, pharmacy benefits managers and pharmacists – to help it understand what can be done to provide some relief for the millions of Americans burdened by skyrocketing prescription drug costs.

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