Regulatory Focus Quotes Anna Abram on FDA Centers’ Hiring

For its article “User fee hiring: CBER on track while CDER lags,” Regulatory Focus quoted Akin lobbying & public policy senior advisor Anna Abram. The article looks at the discrepancy in hiring patterns at the US Food and Drug Administration (FDA) for staff at FDA’s drugs and biologics centers, the Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER). According to the article, the former has reached 57% of its full year hiring goal under the Prescription Drug User Fee Act, while the latter has only filled 34% of the position it aims to fill this year by the end of the second quarter.

Anna said that there may be something “more challenging in the CDER context, and it becomes a more granular question: is there a particular scientific area in which they are encountering a little bit more challenge in hiring than they anticipated? Another way to look at it, will they make it up in Q3?”

She followed by noting that hiring goals are “integral and arguably a launching pad for the agency’s work…I don’t think the agency would agree to something that they do not think they could achieve.”