'Cures,' User Fees and Automation: Woodcock Details Priorities and Challenges for 2017

Regulatory NewsRegulatory News | 15 December 2016 |  By 

The US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Director Janet Woodcock said Wednesday at the FDA/CMS Summit in Washington, DC, that she's looking to develop a plan to automate processes for new drug reviews, implement provisions of the 21st Century Cures Act and support the reauthorization of the user fee acts in 2017.

21st Century Cures

On Tuesday, President Obama signed the 21st Century Cures Act into law, ushering forth a number of changes to how FDA regulates drug, biologics and medical devices.

In an email to CDER staff on Thursday, Woodcock said the center leadership is already working on their implementation plan for Cures.

"The Agency, and CDER, are currently conducting a detailed analysis of the provisions of this Act. Once we have them analyzed and have an implementation plan, we will share this with everyone. I believe that the patient-focused drug development and drug development tools provisions will have the most significant impact on our work, in the sense that they will require additional processes and procedures to be put in place," Woodcock wrote.

However, Woodcock notes that CDER has been working in some of these areas for years: "We've been running programs like that for quite some time … over the last four years of [the Prescription Drug User Fee Act] PDUFA V," Woodcock said, adding that the programs' inclusion in 'Cures' substantiates them as part of the center's mission.

"We will try to accomplish what 21st Century Cures calls on us to do," Woodcock said. "The agency, however, as a whole is chronically under-resourced. That's why, for example, take our IT, why we're behind much of the rest of the world in the kind of IT support we have that actually could improve our efficiency."

One of the act's provisions is intended to help the agency address one of its biggest struggles in recent years: to attract and retain top talent.

"The hiring and the new pay structure that is put in the legislation … would be very advantageous to us in attracting talent and activity and would get people in, in a more efficient manner," Woodcock said.

Currently, Woodcock said that CDER is still "many hundreds of positions below [its staff] ceiling," though she acknowledged that hiring has improved. In addition to her speech at the conference, she also spoke at length with CNBC.

User Fee Act Reauthorization

Keeping with the theme of funding the agency's operations, Woodcock said that CDER is "ready to do whatever is needed" to ensure the existing user fee programs for prescription drugs, generics and biosimilars are reauthorized by Congress.

"That's a huge priority for us," Woodcock said. "We're going to need either continued user fee support, or some other kind of money support if we don't have user fees, for the program to meet the many obligations."

In addition to the existing user fee acts, Woodcock said another priority will be to "modernize" the current over-the-counter (OTC) monograph process and to create a new user fee program to support that system.

"We've been talking to the industry and to many other stakeholders … on reform of the OTC monograph system. That system is not working for us, or I think for the public, very well. It's bogged down," Woodcock said.

While she did not indicate when OTC monograph reform might happen, she told the audience that the agency has "made significant progress" towards a new user fee program in its talks with industry. "Stay tuned on that one," she said.


While not the most glamourous area of reform, Woodcock said that CDER leadership agreed that developing and implementing a plan to "fully automate" its processes for reviewing new drugs is also a top priority.

"We've automated the generic drug process. [Now] we're picking off pieces of other processes that have acute needs. We're working very hard … to figure out how to implement a workflow management system for new drug review," Woodcock said.

Specifically, Woodcock said these improvements will come in the form of revamped IT governance systems.

Part of this plan would be to develop or adopt data standards for additional aspects of new drug submissions to help streamline the agency's workflows.

"For example, just the pure standardized data sets that are submitted under [International Council for Harmonization] ICH are extremely helpful. But, there are many other parts that are not standardized—parts of applications, parts of what we do—and we need to make sure we establish and adhere to data standards," Woodcock said.

Additionally, Woodcock said that automating CDER's processes and implementing data standards will help the center to better understand its workload and how it is performing.

Other Challenges and Priorities

In addition, Woodcock also detailed several other priorities for the center in 2017.

"We're going to continue to drive efforts for mutual reliance with the EU, because we can see the payoff there," Woodcock said, referring to ongoing efforts to implement a mutual reliance agreement for good manufacturing practice (GMP) inspections.

She also hinted that the agency is looking to further increase its efforts to establish mutual reliance agreements in other areas: "Of course there's a possibility to expand this to other regions and other types of inspections in the future, but this is what we're starting on."

Woodcock also said that CDER is working to release a number of outstanding guidances that were expected in 2016, most notably its long-awaited draft guidance on biosimilar interchangeability.

"It's getting less likely as we get more toward the end of the year," Woodcock said. "We'd like to get the remaining guidances that are kind of pending out as soon as possible, but obviously we only have a few weeks left and much of them are holiday time."


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