The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has outlined priority goals in 2017, which include improved informatics, the implementation of the 21st Century Cures Act, reauthorization of user fees for new drugs, generics, and biosimilars, and evaluating the new drug review process, in a recent FDA podcast in which Janet Woodcock, MD, director of the CDER, spoke.
The number one priority for the FDA is improving informatics process management across the whole of CDER. To that end, the agency has set up a governance board called the Bio Informatics Governance (BIG), which will oversee the data standards effort, the standards boards, the change control boards, process control boards, and process governance as well as the information technology that works into that, Dr. Woodcock said.
The CDER has already implemented this platform in the generic drug review process and in other small processes around the center and hopes to be implementing the platform in some parts of the new drug review process in October.
“[This] requires discipline, it requires that we do have change control boards and governance boards over data, over process standards, and that we standardize our processes so they can be automated,” Dr. Woodcock said.
The CDER aims to have a five-year plan put forth that shows which processes are going to be worked on and standardized and which ones could be put into the platform and automated so that, eventually, a coherent system can be formed that will provide information and knowledge management for the whole CDER.
The FDA’s second priority is implementing the recent provisions of the 21st Century Cures Act (Cures Act), a law passed in December 2016 to expedite the discovery, development, and delivery of new treatments and cures, particularly precision medicines, cancer treatments, and therapies for Alzheimer’s disease. The CDER is still analyzing the legislation to see when it will have to implement some of the act’s provisions and to understand what responsibilities the CDER has under the act.
Another critical priority, on which the agency has already done some work, is shepherding and providing technical assistance to the re-authorization of various user fee under proposed legislation as they move through Congress, Dr. Woodcock noted.
Dr. Woodcock has noted that she has made it a personal priority to work on the evaluative process for a new drug review program in the coming year: “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 Science] 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,” Dr. Woodcock said.
Other priorities the FDA is looking at include: continuing work on the opioid epidemic, including approving new abuse deterrent drug formulations; continuing to modernize the assessment of manufacturing facilities, including working out a concept of operations and having transparent processes, procedures, and timelines under that; and building on the recent mutual agreement with the European Commission to share manufacturing inspection data between US and European regulators.
In addition, the FDA will continue to work on its program for compounding, the pharmacy practice of combining, mixing or altering ingredients of a drug to tailor a medication to the specific needs of an individual patient. Compounded drugs can serve a medical need for certain patients, but they present a risk to patients. FDA’s compounding program aims to protect patients from unsafe, ineffective, and poor quality compounded drugs, while preserving access to lawfully-marketed compounded drugs for patients who have a medical need for them.
Dr. Woodcock noted that there continue to be deaths and harm from compounding, and the agency has to work out a way to manage and control harm that would come from pharmacy compounding. The challenge to the FDA is finding a way to do this that will not strain resources and the field’s resources so that the agency can also conduct its other obligations, according to Dr. Woodcock.
Source: Food and Drug Administration and Energy and Commerce Committee