FDA's Major Priorities for Center for Drug Evaluation and Research in 2017

With President Donald Trump taking office and Republicans gaining control of the government, much has changed since January 20, 2017. A top priority of lawmakers has been healthcare, especially repealing and replacing the Affordable Care Act (ACA).

Trump and other GOP lawmakers have supported the idea of revising some processes of the FDA in order to expedite approvals and improve patient access to life-saving prescription drugs.

In a new episode of the Director’s Corner podcast, which features commentary from Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research (CDER), the agency’s top priorities for the year ahead were discussed.

Dr Woodcock stressed that the CDER’s top priority for 2017 was implementing informatics process management, and improving the agency’s approach along the way. The CDER also created the Bio Informatics Governance, which deals with data standards, standards boards, changing control boards, process control boards, and process governance, according to the episode.

Thus far, the platform has already been integrated into the Generic Drug Review process, and in smaller processes. By October, Dr Woodcock hopes the platform can be implemented in certain parts of the drug review process, and continue building the platform.

The CDER’s second priority is implementing the 21^st Century Cures Act. While some of the provisions do not have specific timelines, implementing them sooner and working under the law’s framework will be beneficial, according to the Dr Woodcock.

Once the law is fully analyzed, and the CDER’s responsibilities are well-known, Dr Woodcock said there will be working groups created to start improving care and implementing the law.

Another priority outlined by Dr Woodcock is to provide assistance in reauthorizing User Fee bills as they move through Congress.

A personal priority for Dr Woodcock is to extensively work to “re-invent, reimagine, refresh, or reinvigorate the new drug review process,” according to the podcast.

For the past 4 months, Dr Woodcock has been holding sessions with the staff in the Office of New Drugs, and plans to hold similar sessions with the Office of Translational Sciences to fully understand what is working with the program and how to improve it.

The FDA’s CDER is also planning to continue the push forward with work related to the opioid epidemic, including the approval of abuse-deterrent drugs.

“We really need to work on encouraging new non-addictive pain treatments whenever we can, because that is one of the major sources of both the opioids that are awash in the system out there, as well as people who inadvertently become habituated to the drugs—it’s just the massive amount of exposure,” Dr Woodcock said.

Additionally, Dr Woodcock said the center will continue to modernize the evaluation of manufacturing facilities to create a transparent process. Recently, the FDA came to an agreement with the European Medicines Agency that will allow entities from both agencies to inspect facilities in their respective countries rather than traveling to various places do so.

The CDER also recently created the Oncology Center of Excellence, which will have research and outreach activities. Dr Woodcock expects the creation of this center to improve innovation, and change how the new drug review is approached, according to the podcast.

The final priority for the FDA’s CDER is compounding, and reducing harm and deaths associated with it. The CDER will devise a plan to control harm from pharmacy compounding without straining financing and the healthcare industry’s resources.

“So, we look forward to another busy and productive year in which we continue to assure that Americans have access to safe, effective and affordable drugs,” Dr Woodcock concluded.