January 8, 2015
The holidays came a little early for the folks at the Center for Drug Evaluation and Research (CDER). They just released their sometimes optimistic, but always enlightening guidance wish list and overall priorities for 2015. Let’s take a look.
CDER Director Janet Woodcock recently said these are her agencies “front burner” priorities:
- Implementing and clarifying statutory provisions on drug compounding.
- Meeting Generic Drug User Fee Amendments (GDUFA) review goals that went into effect Oct. 1 last year.
- Continue the build out of Office of Generic Drugs “super office.”
- Build out the Office of Pharmaceutical Quality.
- Implement and continue to develop Program Alignment Group agreements with the Office of Regulatory Affairs.
She singled out the implementation of a new process, data and document management IT system as a “big deal” goal this year
But there’s plenty more on FDA’s big front burner:
- Respond as needed and participate in “21st Century Cures” legislative activities.
- Rapidly re-evaluate regulation of drug advertising and promotion.
- Execute immediate actions required by the Sunscreen Innovation Act and implement a longer-term plan.
- Respond to Ebola outbreak.
- Issue final guidances on abuse-deterrent opioid formulations.
She’s also hoping to fill more than 600 staff vacancies and recruit for a slew of executive positions.
Woodcock’s ambitious goals include five more bulleted pages of additional “important” priorities ranging from implementing a biosimiliars program, working on the Drug Label Improvement Initiative and developing a strategic plan for managing a growing pile of drug imports.
In the agency’s spare time, the plan is to issue nearly fifty guidances in advertising, biopharmaceuticals, biosimiliars, clinical medical/pharmacology/statistical/drug safety, electronic submissions, generics, and labeling, among others. Each of these guidances are already under development, CDER said earlier this month.
It’s certainly important to have goals, and a person’s reach should exceed their grasp, etc, but there’s also the problem of over-promising and under-delivering.
FDA’s got a big front burner but maybe not enough cooks, or oven space, to get it all done in 2015. We’ll keep an eye on it and report back throughout the year. Bon appetit.
