CDER Goals for 2017: Improved Informatics, Cures Act Implementation and User Fees

Regulatory NewsRegulatory News | 07 March 2017 |  By 

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) Director Janet Woodcock outlined the critical priorities for 2017 in a new podcast as part of what she said will be "another busy and productive year."

On the informatics front, Woodcock said that last summer, the executive committee of the FDA had a retreat and "the number one item there was improving and really implementing Informatics Process Management and so forth across the whole Center."

To that end, Woodcock said CDER has set up a governance board known as the BIG, or Bio Informatics Governance, which will look to integrate FDA’s data standards effort, the standards boards, the change control boards, as well as process control boards and process governance and IT changes too.

"Now we’ve already implemented the platform in the Generic Drug Review process and in other small processes around the Center. We hope in October to be implementing the platform in some parts of the new drug review process and we hope to keep building on that," she said.

She also said CDER hopes to have a five-year plan showing which processes are going to be tackled and standardized and then "which ones could be put into the platform and automated so that eventually this will all come together into a coherent system that will provide much more information and knowledge management for everyone in the Center."

Cures and User Fees

Woodcock said CDER’s second priority is implementing provisions from the 21st Century Cures Act, which she said her center is still analyzing "to see when we have to implement some of these things. Some of the provisions don’t have timelines, but in fact, the sooner the better for some of them because we might as well working under statutory framework that’s been enacted and not stay in whatever old process we were doing."

An analysis of the Cures provisions that CDER will be responsible for is still progressing, she said,  and then the center plans to "put together working groups and really start making this happen."

Another critical priority, Woodcock pointed to is "shepherding and providing technical assistance to the reauthorization of these various User Fee bills" for new drugs, generic drugs, medical devices and biosimilars.

Her comments echo similar priorities and challenges she outlined at the FDA/CMS Summit last December. In January, CDER outlined which guidance documents are expected this year.

Other Priorities

"Another priority for me personally, is the work I plan to do with the new drug review program in the coming year. We’re undergoing a process to more or less re-invent, reimagine, refresh, or reinvigorate the new drug review process. I’ve held listening sessions for the past four months now with the staff in OND [Office of New Drugs] and I’m going to have listening sessions now with OTS [Office of Translational Sciences] staff and hear what’s working about the program, what’s good, what are best practices, what are pain points, what could be changed, what are the suggestions, and so forth. We’ll also be having a contract to more widely gather information of that sort that hopefully will be implemented soon and then we’ll have multiple work streams for change," she noted.

FDA’s work on the opioid epidemic will also continue, as will its work on improving its manufacturing inspections, Woodcock said.

"We also need to continue to modernize the assessment of manufacturing facilities. This is a really important activity that we’re just starting on. It wasn’t completely baked in to OPQ [Office of Pharmaceutical Quality]. It is a shared activity between our Office of Compliance, OPQ, and ORA [Office of Regulatory Affairs]. And ORA is undergoing a massive reorganization as part of the ‘PAG’ activity. Once that is done we’ll have a new way of interacting with ORA and we’ve already worked out a concept of operations of how that’s going to work."

Those improvements follow FDA’s recently negotiated a mutual reliance initiative with the EU, which Woodcock said "will allow as it’s implemented, sort of country by country, will allow us to rely on those inspectors in that country to inspect facilities in their country and we will not have to inspect those facilities.

"And then finally, compounding—we can’t let up on that. We continue to have deaths and harm from compounding," Woodcock added. "We did in 2016, and we will probably continue to have that. But we have to work out a way that will not totally strain our resources and the field’s resources so we can conduct our other obligations, but at the same time manage to control any harm that would be coming from pharmacy compounding."

In addition to the FDA podcast, Woodcock also spoke with the Pink Sheet on Monday.

FDA Podcast


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