A lot of development dollars are shed when the FDA withdraws approval or requests that a drug be withdrawn from the market because new potential risks have come to light. And it’s not just the brand company that feels the loss.

The latest mutation to the coronavirus, dubbed COVID-19, has sparked a reaction by many national governments, but the expense associated with development of vaccines and diagnostics is considerable.

Fisher Wallace Laboratories of New York has filed a citizen’s petition with the U.S. FDA regarding the agency’s proposed class III designation for cranial electrotherapy stimulators (CES) for treatment of depression. The company argued that the agency disallowed evidence at an advisory hearing regarding this therapy provided by direct rather than alternating current, but also that the FDA had reneged on an earlier decision to classify these devices as class II devices.

Health and Human Services (HHS) Secretary Alex Azar was peppered with questions about the Trump administration’s budget proposal for fiscal 2021 during a Feb. 13 Senate hearing. However, another theme that resonated during the hearing was Senate legislation addressing drug prices. Azar addressed the issue of price caps, while noting that the bill “leaves plenty of room” for both ample profit margins and innovation in drug development.