AMA wants more FDA transparency, physician involvement during COVID vaccine development
Scientists are moving at breakneck speed to develop a COVID-19 vaccine, and the American Medical Association is urging the U.S. Food and Drug Administration to remain transparent during the process.
In a letter sent Tuesday to Commissioner Stephen Hahn, the AMA said it’s beginning to receive an increasing number of “questions and concerns” from physician members regarding the rapidly advancing vaccines.
Specifically, the lobbying group said there is perceived to be “very little” available information about ongoing efforts and the FDA’s planned review processes.
Chief executive of the AMA, James L. Madara, MD, asked the administration to more closely align itself with the physician community and formulate a plan to quell doctors’ concerns.
“The AMA and our physician members are strongly committed to ending this global pandemic and to fighting medical misinformation,” Madara wrote in the letter.
“To help physicians promote vaccine confidence among their patients and the general public, we must start now to provide information, education, and transparency around the FDA’s process for authorization or licensure, as well as the standards by which FDA will review vaccine candidates and the clinical endpoints which the FDA hopes to achieve,” he added.
Hahn has come under some recent fire for overstating the benefits of an experimental blood plasma therapy for COVID-19 patients. He has since apologized for the miscue and vowed to stick to the science going forward, according to an interview with Bloomberg News.
Madara went on to acknowledge that federal regulators are currently facing “unprecedented circumstances,” but more needs to be done to ensure vaccine education and acceptance among communities that have been devastated by the virus.
“We strongly urge the FDA to work more closely with the physician community starting now to develop a plan for further education and transparency surrounding COVID-19 vaccine candidates,” the letter concluded.