Von Eschenbach Confirmed as FDA Commissioner
One of the last acts of former Senate majority leader Bill Frist (R-Tenn) was to push through confirmation of Andrew von Eschenbach as the official head of the Food and Drug Administration (FDA).
One of the last acts of former Senate majority leader Bill Frist (R-Tenn) was to push through confirmation of Andrew von Eschenbach as the official head of the Food and Drug Administration (FDA). Frist had to invoke a seldom-used legislative procedure to overcome a number of “holds” on confirmation by fellow Senators with serious grievances against the agency. But in the end, the Senate strongly endorsed FDA’s new leader on December 7, 2006, with an 88–11 vote in favor of confirmation.
Von Eschenbach became acting head of FDA in September 2005 following the abrupt resignation of Lester Crawford from the job and was nominated to be commissioner in March 2006. Confirmation of the former director of the National Cancer Institute initially was delayed by Democrats angry about FDA refusal to approve an over-the-counter version of the emergency contraceptive pill Plan B. More recently, other Senators mounted protests over sale of the abortifacient RU-486 and FDA opposition to importation of drugs from overseas. Sen. Charles Grassley (R-Iowa) was furious over FDA’s failure to provide all the information he demanded about possible fraud in clinical studies for the antibiotic Ketek.
The new commissioner will have to deal with these and other contentious issues as the official head of this high-profile agency, which has been attacked in recent years for lax oversight of drug safety, too-slow approval of new generic drugs, conflicts of interest among advisory committee members, and overly favorable treatment of Big Pharma. Von Eschenbach has weathered the drawn-out confirmation process by limiting his public comments to the need to spur innovation to reflect great progress in molecular biology, but now will have to directly address these and other tough regulatory and legal issues. Inadequate agency funding and the need to renew the prescription drug user fee program are at the top of the list.
Mastering Antibody-Drug Conjugates
December 19th 2024In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.
