Woodcock Lays Out Top CDER Priorities for 2019

Regulatory NewsRegulatory News | 12 December 2018 |  By 

While noting that the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has reached some important milestones in 2018, CDER Director Janet Woodcock also unveiled the center’s priorities for 2019 at the CMS/FDA Summit in Washington, D.C. on Tuesday.

“We’ve generally accomplished what we set out to do” in 2018, she said, noting that in the generic drug space, “we’ve reached a steady state,” while in the new molecular entity (NME) space, CDER has seen a step up in productivity from industry in terms of producing more NMEs with varied science and platforms.

As far as her priorities for 2019, the top slot is for CDER’s work around opioids and opioid addiction, Woodcock said. While there has been “some reduction in prescribing” of opioids, there are still more than 200 million prescriptions for opioids every year and “it’s that kind of exposure and saturation of the environment that’s leading this problem,” she said. “It’s really the general population exposure that we have to focus on.”

The second priority Woodcock mentioned was implementing the legislative framework around drug compounding, where there continue to be reports of contamination or infection. FDA is working with the National Academies of Sciences, Engineering and Medicine, as well as the Kennedy Krieger Institute at Johns Hopkins University to deal with compounding.

The third top priority is the modernization of the Office of New Drugs (OND), which just hired a new director, Peter Stein, who was previously a deputy director. “Over the next year, we’ll be implementing many things we’ve been talking about,” Woodcock said, including regulatory automation tools and a multidisciplinary review template to reduce redundancies. The modernization will also increase the number of offices within OND from five to nine and increase the number of review divisions within those offices from 19 to 30.

The fourth priority mentioned is on implementing provisions of the 21st Century Cures Act, which has been ongoing. Woodcock noted the patient-focused elements that CDER is honing in on, particularly in trying to integrate patient input into regulatory processes. She also mentioned the biomarker qualification program and the real-world evidence framework, which more details on both have been released in the last week.

And the final priorities laid out by Woodcock were related to implementing the FDA Reauthorization Act (user fee legislation) and other user fee goals, in addition to tracking the implementation of Track and Trace legislation, which just recently came into effect.

Looking into the long-term future, Woodcock also said the agency has to look at new ways for exchanging information with industry. The current system of electronic PDFs is not as advanced as it should be considering the current state of technology.


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