Turnaround at FDA's Drug Center: An Interview with Janet Woodcock
This article was originally published in RPM Report
Janet Woodcock returned to the Center for Drug Evaluation & Research after four years as FDA commissioner Andrew von Eschenbach's right-hand woman. We talked to her about why she went back, how things have changed and the challenges that lie ahead.
You may also be interested in...
The stimulus bill provides an unprecedented $1.1 billion for comparative effectiveness research-and does so with none of the key provisions biopharma companies hope to see as the US federal government takes a more active role in the field. The good news: this is only the first round, and there is reason to believe the field is evolving as most pharma companies would want. But this isn't the time for manufacturers to let their guard down.
For FDA's top biologics review manager, Jesse Goodman, the announcement of the membership list of the Federal Coordinating Committee on Comparative Effectiveness Research was also his debut in a new role: acting chief medical officer. His background in infectious diseases and preparedness aligns well with the topside leadership in FDA and HHS.
There's a new drug safety structure at FDA, with the Office of Surveillance & Epidemiology gaining greater influence in how the agency manages things like REMS and product withdrawals. In many ways, it's a codification of an existing relationship between safety and review officials. But some sponsors worry it will also result in a less friendly approval process.