Complex Generics & the Prescription Drug Landscape

Many American adults–nearly 60 million, according to some recent consumer surveys–have difficulty affording their prescription drug medicines even with insurance, putting their health and financial priorities at odds.

Complex generics have the potential to generate significant savings for patients and the health care system. But market dynamics and regulatory complexities are seen as significant hurdles.

What policies can be put into place to safely accelerate evaluation and approval timelines? How could next year’s reauthorization of the Generic Drug User Fee Amendments create opportunities to institute innovative policy changes and how is the pandemic’s spotlight on therapeutics and pharmaceutical development timelines likely to influence the thinking behind complex generic approval processes?

Join The Hill for a discussion with leading medical voices, policy experts, and members of Congress to discuss how complex generic medical alternatives can impact and potentially enhance the American healthcare system.

Tuesday, February 9, 2021

1:00 PM ET / 10:00 AM PT

Speakers:

• Tammy Boyd, Chief Policy Officer & Counsel, Black Women’s Health Imperative
• Alex Brill, Founder and CEO, Matrix Global Advisors; Resident Fellow, American Enterprise Institute
• Dr. Sally Choe, Director, Office of Generic Drugs, FDA
• Rep. Brett Guthrie (R-KY), Ranking Member, Energy and Commerce Committee Subcommittee on Health
• Dr. Kashyap Patel, CEO, Carolina Blood and Cancer Care
• Rep. Peter Welch (D-VT), Co-Chair and Founder, Congressional Affordable Medicines Caucus
• Tonya Winders, President and CEO, Allergy & Asthma Network

Sponsor Perspective:

• Christine Baeder, Senior Vice President, Chief Operating Officer for U.S. Generics, Teva
• Christine Simmon, Senior Vice President, Policy & Strategic Alliances, Association for Accessible Medicines & Executive Director, Biosimilars Council 

Moderator:

• Steve Clemons, Editor-at-Large, The Hill

Sponsor Content Message:

Accelerating FDA approval for complex generic drugs is an untapped avenue for lowering drug prices that can save the U.S. billions while lowering costs for patients. According to an independent analysis commissioned by Teva Pharmaceuticals, regulatory delays for 7 complex generics alone cost the U.S. health system an estimated $1.3 billion each year.

Complex drugs, which include auto-injectors like the EpiPen and inhalers used to treat asthma, are critical to the care of conditions such as metastatic breast cancer, osteoporosis and diabetes. Read the report here.