What if you could get orphan drug-related regulatory and compliance clarity directly from the FDA?
You can, by attending this webinar.
Brian Malkin is a partner at McDermott, Will & Emery who spent time in the Office of the Commissioner and the Center for Drug Evaluation and Research (CDER) at the FDA. Along with Aaron Friedman, senior regulatory counsel in the FDA’s Office of Orphan Products Development (OOPD), and Karin Hoelzer, director of policy and regulatory affairs at the National Organization for Rare Disorders® (NORD®), he will discuss the recent decisions and litigation related to orphan drugs, ensuring you understand the implications and the FDA’s challenges.
The presentation team will reveal perspectives from a cross-section of current and former FDA regulators, FDA litigators and major orphan drug trade organizations.
You’ll discover how the FDA has resolved some issues, is seeking legislative fixes for others (such as those in the Catalyst decision and the Avadel litigation) and what additional changes the agency might make (including the recommendations in the Government Accountability Office’s 2018 report).
They’ll also show you the potential pathways forward for greater regulatory transparency, accountability and predictability.
All so you’re more secure in how to proceed with your orphan products.
- Why orphan drug development — and transparent, consistent, predictable decisionmaking by the regulators — helps the industry, affected patients and their healthcare providers
- Recent regulatory decisions and legislative changes regarding orphan drug exclusivity — e.g., when a plausible theory of clinical superiority must be demonstrated to obtain orphan drug exclusivity for a “same” drug (same active moiety/ingredient and orphan indication), newer rulings on being considered an orphan drug based on lack of ability to make a profit on the drug (is this still viable?), and orphan drug labeling considerations for same disease/condition or use/indication
- How the FDA interprets statutes and promulgates regulations, and what happens when federal courts/appeals courts determine the agency did not interpret correctly
- The Government Accountability Office’s (and others’) recommendations to OOPD to improve decisionmaking and whether such recommendations have been implemented — and, if so, to what effect?
- Legislative or other changes that may be contemplated or recommended for orphan products
If you’re selling, developing or considering developing orphan products or products with potential orphan indications, you need the information these FDAers and rare disease advocates have to share!
Who Will Benefit:
- Regulatory affairs
- Government affairs
- Regulatory counsel or in-house counsel and outside counsel