Deborah Autor, FDA’s Deputy Commissioner for Global Regulatory Operations and Policy, to Join Mylan
PITTSBURGH, April 30, 2013 /PRNewswire/ — Mylan Inc. (Nasdaq: MYL) today announced that it has appointed Deborah M. Autor as senior vice president, Strategic Global Quality and Regulatory Policy. Autor joins Mylan from the U.S. Food and Drug Administration (FDA), where she served for 11 years, most recently as deputy commissioner for Global Regulatory Operations and Policy. At Mylan, Autor will focus on further advancing Mylan’s efforts to lead the industry in establishing one global quality standard for pharmaceutical products and expanding the world’s access to high quality medicine.
Mylan CEO Heather Bresch commented, “We are thrilled to welcome Deb to Mylan in this unique role and believe that her experience, dedication and commitment to advancing global quality standards at FDA align with Mylan’s commitment to ensuring one high quality standard for our products wherever they are made. Deb’s insights into the challenges of globalization to the health care sector will be extremely valuable as we continue to seek to raise the bar on quality standards for the industry around the world. Our goal is to ensure that anyone taking medicine anywhere can be confident in the quality standards used to produce it.”
Mylan President Rajiv Malik added, “Mylan’s reputation for quality has distinguished our company since its founding more than 50 years ago and helped fuel our growth into a global pharmaceutical leader. We believe Deb’s decision to join Mylan speaks to the culture of quality she has seen embedded within our organization and believe that Deb can help further differentiate Mylan from its competitors in terms of quality, integrity and service as we seek to provide the world’s 7 billion people with access to high quality medicine.”
Autor commented, “Mylan has been a leading advocate for ensuring one quality standard, both internally and externally, as evidenced by the company’s active role in the development and passage of the FDA Safety and Innovation Act, or FDASIA. I am very excited to be joining an organization whose people demonstrate such extraordinary passion and commitment to quality and access to medicine. I look forward to contributing to Mylan’s continued leadership on quality – both from an operational and policy perspective.”
Most recently, Autor oversaw the Office of Regulatory Affairs and the Office of International Programs at FDA, with responsibility for 4,400 employees. In this role, she led the implementation of FDA’s strategy for addressing the challenges of globalization and import safety. Under Autor’s leadership, her organization made great strides in becoming more data-driven, strategic and risk-based, moving closer to its vision of a strong global product safety net in which all food is safe, all medical products are safe and effective, and the public health is advanced and protected.
Prior to assuming the role of deputy commissioner, Autor served for five years as director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research (CDER). In that role, she led policymaking and enforcement for key public health programs for drugs, including current good manufacturing practices, human-subject protection and bioresearch monitoring, marketed unapproved drugs, pharmaceutical import and export, Internet and health fraud, over-the-counter monograph compliance, adverse-event reporting, registration and listing, and drug recalls. Under Autor’s leadership, CDER’s Office of Compliance worked to minimize consumers’ exposure to unsafe, ineffective and poor quality drugs.
Autor also served in the CDER Office of Compliance as a senior advisor and as associate director for Compliance Policy. Prior to joining FDA, for seven years, Autor represented the agency as a litigator at the U.S. Department of Justice (DOJ).
In recognition of her contributions to public health, Autor was awarded the 2011 Meritorious Executive Presidential Rank Award, the 2011 Food and Drug Law Institute’s Distinguished Service and Leadership Award, and was a 2010 finalist for the prestigious Service to America Medal. Autor obtained her B.A. from Barnard College of Columbia University and her J.D. magna cum laude from Boston University School of Law, where she was an article editor for the Boston University Law Review.
Mylan is a global pharmaceutical company committed to setting new standards in health care. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what’s right, not what’s easy; and impact the future through passionate global leadership. We offer a growing portfolio of approximately 1,100 generic pharmaceuticals and several brand medications. In addition, we offer a wide range of antiretroviral therapies, upon which approximately 40% of HIV/AIDS patients in developing countries depend. We also operate one of the largest active pharmaceutical ingredient manufacturers and currently market products in approximately 140 countries and territories. Our workforce of more than 20,000 people is dedicated to improving the customer experience and increasing pharmaceutical access to consumers around the world. But don’t take our word for it. See for yourself. See inside. mylan.com
SOURCE Mylan Inc.