Charging for Investigational Drugs and Devices – Webinar Recording/Transcript
If you’ve been enticed by the FDA’s investigational drug cost recovery program or charging subjects and investigators for the costs of manufacture, research, development and handling of your investigational device, you owe it to yourself to first attend this presentation by a former FDAer.
The FDA is providing opportunities for investigational drug and device direct cost recovery.
But before you assume this is your big break, know there are possible downsides: Have you considered that charging for your investigational product might depress recruitment rate and create barriers to access that can worsen disparities in clinical trial participation?
Two Wilson Sonsini Goodrich & Rosati lawyers — one of whom is a former FDA official — are here to help you take advantage of the opportunities and understand and avoid any potentially negative consequences.
Of counsel Paul Gadiock, who was previously associate center director for policy at the FDA’s Center for Devices and Radiological Health (CDRH), and associate Olivia Cusimano will clarify the FDA’s current stance on charging for investigational drugs and devices. And they will share what you must consider before taking any such action.
- The factors to consider when deciding whether to seek cost recovery from participants in different clinical trial phases, such as retaining runway revenue and maintaining adequate recruitment
- Which investigational drug expenses can be recovered without FDA authorization, which can only be recovered with FDA authorization and which cannot be recovered at all
- The documentation requirements for sponsors to receive FDA authorization for cost recovery under the agency’s most recent guidance, Charging for Investigational Drugs Under an IND: Questions and Answers
- The FDA’s expanded access requirements for charging for investigational drugs
- The FDA’s cost-recovery framework for investigational devices
Investigational drug and device cost recovery can be pivotal to overcoming the financial hurdles of clinical trials. But don’t be so eager that you ignore the potential pitfalls. Find much-needed clarity by listening to this presentation.
Meet Your Presenters
Paul Gadiock, of counsel in the San Francisco office of Wilson Sonsini Goodrich & Rosati, primarily focuses on helping small and large medical device companies efficiently navigate local and national regulatory requirements. He brings unique first-hand experience with the development and application of regulatory programs to counsel clients at all stages of the medical product lifecycle, providing premarket and postmarket regulatory solutions for medical product clients. Previously, he served on the senior leadership team at CDRH. In this role, he advised key agency officials on issues related to the application of policies, programs, regulations and legislation, and was instrumental in appropriately encompassing or excluding devices from the scope of medical product regulation.
Olivia Cusimano, an associate in the Palo Alto office of Wilson Sonsini Goodrich & Rosati, represents a wide range of clients in the technology space, including biotech, emerging drug and medical device companies, software and hardware companies, through all stages of their lifecycle. She also maintains a robust FDA regulatory practice related to the regulation of cannabis and other breakthrough therapies.
Who Will Benefit
- Regulatory affairs personnel
- Finance officers
- Clinical trial coordinators
- Those related to the development and clinical evaluation of experimental drugs and devices
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Nov. 9, 2022