CDER Priorities Include New Drugs Modernization
CDER director Janet Woodcock says her top priorities include modernizing the new drug review program and hiring a permanent director for the Office of New Drugs (OND). Woodcock has been overseeing OND since former director John Jenkins retired 1/2017. His departure became controversial after he made it clear that he had delayed his retirement out of concern that Woodcock would step in as acting director and damage the new drugs review program (see earlier story). Their contentious relationship came to a boil after Woodcock supplanted reviewers’ judgment with her own and and cited a “totality of evidence” standard in the 2016 approval (see earlier story) of Sarepta’s Duchenne drug Exondys 51 (eteplirsen).
“We are assuming a broad modernization process for the new drugs program which includes not just new drugs but also supporting statistical quality, clinical pharmacology, and we are well into that, which includes restructuring of the review process as well as restructuring the organization,” Woodcock told an Alliance for a Stronger FDA gathering in Washington, DC 9/21. “So I would hope by next summer we could stand up that new organization and we would have the new processes piloted, and we would be using some of them and we would be off in a new direction that would be firmly established.”
Earlier this summer, Woodcock proposed changes to her Center’s new drug regulatory program that are intended to free up resources so staff can “focus on drug development, particularly for unmet medical needs, and on the multiple collaborations needed to make sure candidate drugs are developed and assessed properly, with appropriate input from external scientists, expert physicians and patient communities.” Proposals include regulatory and review process changes, organizational restructuring and improved information technology (IT), she said at the time.
Under the reorganization, the number of offices that oversee the review divisions would nearly double from five to nine. Within those offices, Woodcock said up to 30 review divisions would be established — up from the current 19. Woodcock said the reorganization would enhance the Center’s focus on multidisciplinary teams in the drug review process. “A central component of our proposed changes involves stronger integration of our talented staff so they can better work together – within and across offices, a concept we refer to as ‘integrated assessment,’” she said. “Previously, CDER reviewers would seek consults from specialists in other scientific disciplines (as issues were identified in the course of review). For greater collaboration, a cross-disciplinary team will be assigned to work on a new drug application at the outset.”
To improve CDER’s knowledge management, Woodcock said her proposal would improve IT capabilities and access to information “to better enable the storage and management of the collected experience of our scientific review staff. Accurate historic information from many past drug reviews is essential to informing current and future reviews – and to assure consistent regulatory decision-making. We want to make it easy for staff to find and use scientific and regulatory data, information and precedents.”
In her remarks to the Alliance, Woodcock noted that pharmacy compounding continues to be a public health threat and at the same time it continues to be an essential service, and “so we need to keep up our efforts on bringing that industry up to an acceptable standard and that's going to be a whole series of guidance documents and rule making actions by the agency.” Getting adequate funding for a robust pharmacy compounding program has been a challenge, she said.
“We got a few user fees,” Woodcock continued, “but it is turning out to be more work because we are getting all these nominations from pharmacists who want to compound from bulk drugs for all these obscure diseases, and we have to get our medical staff and toxicologists to go over all the stuff... Plus we are still finding all these violative pharmacies. We just found one that had a dog bed outside the clean room. We are seeing people shipping sterile drugs that have visible stuff floating around in them and so forth. And so we have to have an enforcement presence... We asked in this budget to have money for a center of excellence to train the 503b pharmacy facilities and we need to get them up to a level where they are making fit-for-purpose drugs and not life-threatening products. So that program is pretty deficiently funded.”
Additionally, hiring continues to be an issue at CDER, Woodcock acknowledged, and if the Center were fully staffed there would not be enough office space at FDA’s headquarters in White Oak, MD, to house everyone. Currently, there are 6,023 allocated positions for CDER and 5,003 are on board right now. The capacity at White Oak is just over 5,500.
Woodcock said there was a “triple conundrum” to hiring all the allocated positions. “If we hire all these people, we would have less operating cash and we are spending a lot of the operating on contractors to get certain kinds of work, and we are also investing this money in IT and other systems.”