On this episode of the podcast, Terry and Bob discuss the Food and Drug Administration and its lessons learned from the pandemic. They highlight how best practices from Operation Warp Speed and research on Covid-19 long haulers can inform ongoing treatments for those in the rare and chronic disease community. 

They discuss the threat to patients posed by Colorado’s proposed drug price review board, which would set an upper payment limit for treatments, threatening access and innovation for those who need them most. They highlight efforts in Texas to pass a copay accumulator ban to help patients who receive copay assistance access their treatments. And Bob explains how ICER inherently discriminates against minorities and the chronically ill by using an arbitrarily low value for a year of life, among other problems with its methodology.  

Bob interviews FDA Acting Commissioner Dr. Janet Woodcock, who explains how the pandemic is helping to democratize clinical research and clinical trials. She highlights how the 21st Century Cures Act has helped more drugs get approved through accelerated and breakthrough designations. And she notes that through personalized medicine, FDA regulators can make better risk/benefit analyses for treatments. She argues that those who seek cost containment shouldn’t pick on those dying from cancer and rare diseases. Rather than focus on cost, she explains, we should consider broader cost containment.

Patient correspondent Kate Pecora interviews Teonna Woolford, who has sickle cell disease. Teonna discusses the intersection between this illness and reproductive health and her efforts at helping patients with fertility preservation. She argues that this disease, which disproportionately affects people of color, is the posterchild for healthcare discrimination and disparities. She points out how other less common illnesses like cystic fibrosis nevertheless receive far more attention and funding. Sickle cell patients often get viewed by doctors as drug-seekers. And she highlights how sickle cell patients — and all patients with rare diseases — are threatened by efforts to curtail treatments that receive FDA accelerated approvals. 

Listen HERE