Accelerated Approvals & The Pathway to Treatments

Last year the Food and Drug Administration approved 14 new drugs including those for various types of cancer, kidney disease, diabetes and Crohn’s disease via an accelerated approval pathway that fast tracks potential life-saving treatments to patients. 

The program allows the FDA to approve drugs that treat serious conditions and which fill an unmet need in a shorter time frame than the regular approval process, based on variables that suggest the drug likely works. Drugmakers are then required to conduct trials after receiving an accelerated approval.

The FDA’s recent approval of an Alzheimer’s drug has put the accelerated approval process in the spotlight with critics focused on what they call safety risks and advocates focused on the importance of patient access to promising experimental drugs. 

The Hill will bring together policymakers, patient advocates and experts for a conversation on expedited drug approvals.

Tuesday, April 26, 2022
1:00PM ET/10:00AM PT

Speakers:

• Rep. Neal Dunn, MD (R-FL), Member, Energy & Commerce Committee & Doctors Caucus
• Rep. Brian Higgins (D-NY), Sponsor, Comprehensive Care for Alzheimer’s Act; Member, Ways and Means Subcommittee on Health
• Rep. Brad Wenstrup, MD (R-OH), Co-Chair, Doctors Caucus; Member, Ways and Means Subcommittee on Health
• Dr. Mark McClellan, Former Commissioner, FDA; Former Administrator, CMS; Founding Director, Duke-Margolis Center for Health Policy, Duke University
• Cynthia Rice, Chief Mission Strategy Officer, JDRF
• Jamie Sullivan, Senior Director for Policy, EveryLife Foundation for Rare Diseases
• Neil Thakur, Chief Mission Officer, ALS Association

Sponsor Perspective:

• Dr. Maria Carrillo, Chief Science Officer, Alzheimer’s Association
• Kristen Clifford, Chief Program Officer, Alzheimer’s Association
• Joe Montminy, Patient Advocate

Moderator:

• Bob Cusack, Editor-in-Chief, The Hill

Join the conversation! Tweet us: @TheHillEvents and #TheHillAlz

SPONSORED CONTENT MESSAGE:

The Alzheimer’s Association is leading the way to end Alzheimer’s and all other dementia — by accelerating global research, driving risk reduction and early detection, and maximizing quality care and support. But today, there are still more than six million Americans living with Alzheimer’s disease, and 11 million more are providing unpaid care to them.

Thanks to supporters, advocates and congressional champions, we are one step closer to finding a cure, but to achieve this goal, we need further support of innovation and research. The FDA’s Accelerated Approval pathway is a critical tool for bringing therapies to people currently living with unmet medical needs like Alzheimer’s disease. It is because of this pathway that lives have been lengthened, improved and saved.