Advocacy

Speak Up for Access

Healthcare is an issue we all care about, and all of us—including those we love—will need medicine one day. AAM encourages voters and patients to advocate at the federal and state level for accessible prescription drugs. Your voice and your stories make a difference to policymakers and regulators.

Although advocacy priorities can change from month to month and year to year, a foundational principle remains: policy that helps foster a sustainable market for the generic and biosimilar industry ensures lower-cost medicines are always available for America’s patients.

Federal Advocacy

Generics and biosimilars—cornerstones of the U.S. healthcare system—have provided a reliable safety net for millions of Americans, ensuring access to vital therapies at the lowest possible cost. Yet, a perfect storm of federal regulatory hurdles, patent abuses, and flawed policies threatens the very foundation of this system, putting patients’ health and financial stability at risk.

Biosimilars

Biosimilars have the potential to improve the quality of life for patients while at the same time saving the health system billions of dollars each year.

GDUFA/BsUFA User Fees

Over 10 years of the Generic and Biosimilar programs at FDA, the generic and biosimilar industry has provided more than $4 billion for review and approval of lower-cost treatments for America’s patients. The result is more than $3 trillion in savings to patients, including $445 billion in savings in 2023 for patients and the U.S. healthcare system via FDA-approved generic and biosimilar medicines Savings from biosimilar medicines alone increased to $12.4 billion in 2023 and $36 billion since the first biosimilar entry in 2015.

Intellectual Property & Patent Reform

AAM opposes abuses of the patent system by brand-name drug companies, and we advocate for patent reform that lends itself to timely patient access to safe, effective and more-affordable medicines for patients in the United States.

Medicaid Generics Penalty

Unless it is repealed, the Medicaid Generics Penalty could destabilize the robust market for generic drugs and impede patient access to affordable, lifesaving drugs.

State Advocacy

In addition to efforts surrounding federal policy, AAM also works at the state level to promote best practices aimed at increasing the use of generic and biosimilar medicines and saving taxpayer money. These efforts include rapid responses to anti-substitution stories, advocating for specific generic substitution laws and general education.

Tariffs & Trade

AAM promotes and protects access to affordable medicines in trade agreements and represents these interests before the U.S. Trade Representative, the Department of Commerce, Congress, The White House and other stakeholders.

Advocacy

Speak Up for Access

Federal Advocacy

Biosimilars

GDUFA/BsUFA User Fees

Intellectual Property & Patent Reform

Medicaid Generics Penalty

State Advocacy

Tariffs & Trade

Advocacy

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