New staff puts PDUFA goals back on track, Jenkins says

Share this article:
A two-year hiring push at the FDA's Center for Drug Evaluation and Research (CDER) has added enough new staff to bring itself back on track with meeting Prescription Drug User Fee Act (PDUFA) goals, according to Office of New Drugs (OND) director John Jenkins.

Speaking at an Elsevier conference, Jenkins said he reversed a 2007 directive that allowed OND managers to miss PDUFA goals due to workload constraints caused by implementing the FDA Amendments Act (FDAAA) and the renewal of the user fee program. At the time, Jenkins instructed review managers that they may miss PDUFA deadlines by up to two months and decline some sponsor meeting requests, among other steps to manage workload and staff shortages.

Over the past two years, the CDER has grown by 760 employees (34%) and the OND by 183 employees (26%). The downside, he said, is that 38% of the staff at the CDER and the OND have been on the job for less than two years. It's estimated that it can take over three years for a reviewer or project manager to be fully productive.
Share this article:
You must be a registered member of MMM to post a comment.
close

Next Article in Legal/Regulatory


Does a health psychology approach hold the key to Rx adherence? In MM&M's latest Leadership Exchange Uncut eBook, industry stakeholders from the payer, provider, academic and pharma realms explore the "why" behind medicine taking. Access here.