By oracknows on August 16, 2015.
The approval of new drugs and medical devices is a process fraught with scientific, political, and ethical landmines. Inherent in any such process is an unavoidable conflict between rigorous science and safety on the one side, which tend to slow the process down by requiring large randomized clinical trials that can take years, versus forces that demand faster approval. For example, patients suffering from deadly diseases demand faster approval of drugs that might give them the hope of surviving their disease, or at least of surviving considerably longer. This is a powerful force for reform, as evidenced by HIV/AIDS activism in the 1980s and 1990s that led to the development of fast-track approval mechanisms for drugs for life-threatening conditions, a change whose effects have been mixed. It s also a powerful force potentially for ill, as I ve documented in my posts about the understandable but misguided right-to-try movement. Af
The administration is promising to purchase even more vaccine doses as they become available from the vaccine makers, and to use the Defense Production Act to spur production. But federal health officials and corporate executives said those were longer-term goals because the supply for the first three months of the year was essentially fixed.
The Trump administration invoked the Defense Production Act to force suppliers to prioritize orders from Pfizer, Moderna and other vaccine makers whose products are still in development. Health officials said it was unclear how the new administration could use the law beyond that to boost production.
Credit: The White House
As a new federal administration begins to take shape under President Joe Biden, a growing list of University of California-affiliated alumni and faculty have been nominated or appointed to positions in the new government.
California native Kamala Harris, a graduate of UC Hastings College of Law, is undoubtedly the most prominent of these new faces. With her swearing-in on Jan. 20, she becomes the first UC-affiliated person to ever hold the vice presidency. Dozens of UC-affiliated people, representing virtually all UC campuses, have been tapped to serve in the new administration.
Public service is one of the three core elements of UC’s mission, and these former UC faculty and alumni manifest this mission at its highest level.
Dr. David Kessler, who helped speed the development and approval of AIDS drugs in the 1990s, will become the top science official at Operation Warp Speed.
UVa physician Cameron Webb joins Biden White House COVID team Photo: WINA
CHARLOTTSVILLE (WINA) – UVa physician and former 5th District Congressional candidate Dr. Cameron Webb is joining President-elect Biden’s White House COVID Response Team. Webb is no stranger to the White House since he worked as a White House Fellow in the Obama Administration in 2016 and through the transition to the Trump Administration. After that, he joined the UVa faculty where he has been an assistant professor of medicine and public health sciences, and as director of health policy and equity at the UVa medical school.
Webb will be Senior Policy Advisor for COVID-19 Equity on the new White House COVID team.