The “Right to Try” movement has brought to the forefront the debate regarding the most effective and safe way for patients to gain access to investigational therapies. Proponents of “Right to Try” argue for less governmental oversight and alternative pathways to access; deterrents decry “Right to Try” legislative efforts as providing false hope to patients, and as being unnecessary in light of the existing expanded access regulatory pathways overseen by the Food and Drug Administration (“FDA”). President Trump, in his first State of the Union address, called on Congress to pass a bill allowing terminally ill patients to request access to experimental drugs, articulating Administration support for recent efforts to pass a federal “Right to Try” bill. The evolving legislative landscape has many stakeholders wondering how to request – and receive requests – for patient access to investigational products. Where do the several proposed federal “Right to Try” bills stand today? How would an enacted federal “Right to Try” law interact with the FDA’s recently streamlined process for expanded access to investigational drugs and the potentially inconsistent requirements of already enacted state “Right to Try” laws? Which requirements will apply and when?
In this webinar, Robert Romanchuk, IRB Chair at Advarra, Kate Gallin Heffernan, Partner and Chair of the Academic and Clinical Research Group at Verrill Dana, LLP, and Marylana Saadeh Helou, an Associate practicing in the Academic and Clinical Research Group at Verrill Dana, LLP, will provide an overview of the current state of the FDA’s Expanded Access Program and “Right to Try” legislative efforts at the state and federal levels. The presenters will also analyze key terms of approved and proposed “Right to Try” legislation, and discuss what the recent emphasis on “Right to Try” – in the context of FDA’s existing Expanded Access Program – means to various impacted parties including, institutions, physicians, investigators, manufactures, patients and IRBs involved in requests for access to investigational products.
In this free webinar, we will:
- Identify the recent streamlining changes undertaken by the FDA to increase the efficiency of the Agency’s response to requests for expanded access and the mechanisms patients can use outside of a clinical trial to get access to an investigational device for treatment.
- Describe key ways in which “Right to Try” legislation (both state and federal) deviates from the existing FDA expanded access pathway.
- Explain practical considerations for stakeholders involved in requests for expanded access given the shifting legislative frameworks and potentially competing requirements at the state and federal levels.
Who Should Attend
- IRB members
- Manufacturers of FDA-regulated products
- Research sites and other institutions
- Patient advocacy groups.
Certificates of attendance are available for this event. The presentation may qualify for continuing education credits; check with your certifying organization(s) for more information.
Wednesday, May 30
Presentation: 2:00-3:00pm ET
Q&A: 3:00-3:15pm ET