To say a lot is riding on the Nov. 3 presidential and congressional election in the U.S. would be an understatement, as the outcome could impact drug pricing, patent reform, research spending and pandemic response and preparedness.
The push for a vaccine for the COVID-19 pandemic may have no parallel in pharmaceutical history, and FDA commissioner Stephen Hahn vowed in a Senate hearing that the agency will rely on the agency’s traditional standards for scientific evidence in premarket reviews of those vaccines.
The Senate Health, Education, Labor and Pensions (HELP) Committee met again June 23 to discuss the federal government response to the COVID-19 pandemic, and one clear signal that emerged from the hearing is that Congress will have to provide annual funding to build a sustainable infrastructure for vaccine development and manufacture if the nation is to deal appropriately with the next pandemic.
The COVID-19 pandemic has fueled an unprecedented uptick in telehealth use, from medical and behavioral health services to remote patient monitoring, as federal and state regulators have relaxed certain policy restrictions to increase access to care. Sen. Lamar Alexander (R-Tenn.) recommended in a Senate hearing that certain temporary policy changes, such as elimination of the “originating site” rule and expansion of Medicare- and Medicaid-covered telehealth services, should be lasting to ensure patients retain health care access when the crisis is over.
Stephen Hahn, of the MD Anderson Cancer Center, generally managed to avoid any controversy in today’s Senate confirmation hearing for the FDA commissioner’s job, stating for instance that he is “open to all science and data that could potentially support” drug reimportation as a solution to the drug pricing problem.