PhRMA Statement on U.S. Food and Drug Administration COVID-19 Emergency Use Authorization Vaccine Guidelines
WASHINGTON, D.C. (October 6, 2020) – Pharmaceutical Research and Manufacturers of America president and CEO, Stephen J. Ubl made the following statement about reporting around the U.S. Food and Drug Administration (FDA) drafting new guidelines to bring about greater clarity and continued scientific rigor to the review and potential approvals of COVID-19 vaccines for emergency use authorization:
“PhRMA represents an industry built on the bedrock of scientific rigor. Back in September, leading biopharmaceutical companies researching and developing potential vaccines for COVID-19 issued a pledge ‘to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines.’
“This commitment to supporting a sound, scientific and deliberative process for the development and review of COVID-19 vaccines has not wavered.
“PhRMA supports any efforts by FDA to provide clarifying guidance and we have engaged with the agency to support bringing greater transparency to the review process for COVID-19 vaccines. To help address this public health crisis, our companies have also taken unprecedented steps to share vaccine clinical trial protocols and data in real time. We welcome the agency’s efforts to instill confidence in the rigorous safety of these potential vaccines.
“Science is guiding every aspect of our work. We remain focused on ensuring the highest of standards of patient safety, research, clinical testing and manufacturing are upheld throughout the vaccine research and development process.”
The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading innovative biopharmaceutical research companies, which are devoted to discovering and developing medicines that enable patients to live longer, healthier and more productive lives. Since 2000, PhRMA member companies have invested nearly $1 trillion in the search for new treatments and cures, including an estimated $83 billion in 2019 alone.