One Quality Standard

One Quality Standard

July 9, 2014

Our mission is to provide 7 billion people access to high quality medicine. But access is about more than stocking pharmacy shelves.

It’s all about driving and championing policy. Policies that improve access. Policies designed to change restrictive laws that limit access. And polices that promote one global standard of quality for all medicines.

Why so passionate about policy? Because we believe in breaking down the barriers between safe, effective and affordable medicines and the people all over the world who need them.

Policies We Support

Promoting One Quality Standard: U.S. legislation, including the Food and Drug Administration Safety and Innovation Act and the Generic Drug User Fee Amendments, expand the global reach of the Food and Drug Administration and ensure regular inspection of, and high quality standards for, all manufacturing facilities that supply the U.S. pharmaceutical market.

Increasing Generic Utilization: From 2003 to 2012, generic utilization saved the U.S. health care system an estimated $1.2 trillion. In other countries where generic utilization is low, Mylan is educating governments about how generics can help provide affordable health care and access to medicine.

Driving Biogeneric Access: Biogenerics are generic equvialents of biologics—expensive medicines for diseases like multiple sclerosis, rheumatoid arthritis, diabetes and cancer. We promote effective biogeneric approval pathways that drive interchangeability, maximize patient access to more affordable, high quality biologics and reduce health care spending.

Raising Anaphylaxis Awareness: Food allergies are the most common cause of anaphylaxis, a life-threatening allergic reaction, affecting approximately one in 13 U.S. children. We advocate for policy that expands access to epinephrine, the only first-line treatment for anaphylaxis, to entities such as schools.

Stemming HIV/AIDS: Approximately 35 million people in the developing world are infected with HIV, the virus that causes AIDS. 28 million need treatment. One-third of them receive it. We advocate globally for funding and policies that focus on scaling up proven methods of treatment and prevention.