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Michael Causey

FDA Compliance

FDA’s CDER Has Ambitious ‘Front-Burner’ Priorities

They may need a bigger burner

Published: Thursday, January 22, 2015 - 11:13

The folks at the Center for Drug Evaluation and Research (CDER) 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 review goals that went into effect Oct. 1, 2014
• Continue the build out of the 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 reevaluate regulation of drug advertising and promotion
• Execute immediate actions required by the Sunscreen Innovation Act and implement a longer-term plan
• Respond to the Ebola outbreak
• Issue final guidances on abuse-deterrent opioid formulations

Woodcock is 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 50 guidances in advertising, biopharmaceuticals, biosimiliars, clinical medical/pharmacology/statistical/drug safety, electronic submissions, generics, and labeling, among others. Earlier this month the CDER said all of these guidances are already under development.

It’s certainly important to have goals, and a person’s reach should exceed their grasp, but there’s also the problem of over-promising and under-delivering.

The FDA has 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!

First published Jan. 8, 2015, on the AssurX blog.

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About The Author

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Michael Causey

James Michael Causey’s been a journalist since he started his own neighborhood newspaper in the 1970s. In addition to quizzing FDA officials for the past 10+ years, he’s also interviewed political satirist Art Buchwald, FCC Chairman Reed Hundt, SEC Chairwoman Mary Schapiro, and is the past president of the Washington Independent Writers. Causey is the editor and publisher of eDataIntegrityReport.com and is a contributing writer on the AssurXblog.