Heather Bresch is chief executive officer of Mylan, one of the largest generics and specialty pharmaceutical companies in the world. She also serves on the company’s board of directors.
Mylan’s mission is to provide the world’s 7 billion people access to high quality medicine. Over the course of her 20-year career at the company, Bresch has been a champion of initiatives and policy changes aimed at removing barriers that hinder patient access to high quality medicine. She has testified before the U.S. Congress and the U.S. Food and Drug Administration, among other institutions, on issued related to access to medicine.
Some of Bresch’s key policy priorities include working to ensure that everyone living with HIV/AIDS has access to treatment and advocating for treatment soon after diagnosis to ensure better health outcomes, reduce HIV transmissions and create long-term cost savings. As part of this effort, Bresch has worked to call attention to access issues in developing countries for patients in need of antiretroviral (ARV) treatment for HIV/AIDS. Further, she has helped position Mylan as a leader in the development and manufacture of ARVs. Today, approximately one out of three people in the developing world being treated for HIV/AIDS depends on a Mylan ARV product.
In other efforts to drive access to medicine, Bresch is actively advocating for the implementation of a viable abbreviated approval pathway for safe and effective generic versions of biologic drugs to provide patients with access to lower-cost versions of life-saving products. She also is working to increase generic drug utilization around the world, particularly in markets where generic utilization rates remain relatively low.
In addition, Bresch is passionate about increasing awareness of food allergies, which can sometimes lead to a life-threatening allergic reaction, called anaphylaxis. She is active in increasing awareness of the risk, symptoms of anaphylaxis, encouraging preparedness to respond when anaphylaxis occurs, and having immediate access to Epinephrine auto-injectors, as Epinephrine is considered the first-line treatment for anaphylaxis.
Bresch also has been a leading advocate for one quality standard for all drugs sold in the U.S. She was instrumental the development of the Generic Drug User Fee Act and advocated for changes to the Federal Food, Drug and Cosmetic Act of 1938 to arm the U.S. Food and Drug Administration with the resources and authority to regularly inspect U.S. and foreign plants at the same rate, both of which were included in the Food and Drug Administration Safety and Innovation Act (FDASIA).
Earlier in her career, Bresch played a vital role in the passage of the 2003 Medicare Modernization Act, a congressional revision to the Hatch-Waxman Act of 1984, which helped to ensure consumer access to affordable pharmaceuticals.
Throughout her career with Mylan, Bresch has held roles of increasing responsibility in more than 15 functional areas. Prior to becoming CEO, Bresch served as Mylan’s president, where she was responsible for the day-to-day operations of the company. Before that, she served as Mylan’s chief operating officer and chief integration officer, leading the successful integration of two transformational and game-changing international acquisitions – Matrix Laboratories and Merck KGaA’s generics business. In addition, Bresch has served as head of Mylan’s North America operations.
Bresch has served two consecutive terms as chairman of the Generic Pharmaceutical Association and one term as its vice chairman. Bresch earned her undergraduate degree from West Virginia University.