In 2018, the U.S. Food and Drug Administration (FDA) announced plans to modernize the New Drugs Regulatory Program (NDRP) of the Center for Drug Evaluation and Research (CDER). Implementation of the plans began in 2019 and included a reorganization of certain offices within the NDRP. The revised structure is meant to improve efficiency and position the FDA to better meet the needs of new drug sponsors by increasing the number of reviewing divisions and allowing each to focus on certain types of drugs.

Specific changes are to include . . .

• Grouping Office of New Drugs (OND) offices and divisions by therapeutic area to distribute workload and align to changes in the pharmaceutical landscape

• Increasing the number of clinical offices that oversee review divisions from six to eight

• Increasing the number of clinical divisions from 19 to 27, plus six divisions of pharmacology/toxicology, creating divisions with clearer and more focused areas of expertise

• Establishing the new Offices of Program, Administrative, and Regulatory Operations; an Office of New Drug Policy; and an Office of Drug Evaluation Sciences

While the FDA’s objectives are above reproach, the words “government reorg” are not likely to inspire confidence and joy. So, with the reorganization now several months along, you might wonder how things are going.

We at the Bracken Group (TBG) are happy to report that they are going well.

One of the first divisions to be impacted by the FDA reorganization was the oncology division. Several TBG clients were engaged with the agency at the time, including one for which TBG was submitting an Investigational New Drug (IND) application. The process went smoothly.

In fact, in every case that we at TBG are aware of, including those in which sponsors were moved from one division to another midstream, the FDA managed the process with transparency and efficiency. We have every reason to believe that subsequent transitions will also go well and that the reorganization will ultimately deliver an improved experience for sponsors.

Whatever is or is not going on at the FDA at any moment in time, it’s always a good idea to be as open and communicative with the agency as possible. Stay close to your regulatory professionals, because things can change, particularly in regard to the specifics or nuances of any individual review division or project.

Partnering with consultants who are in daily contact with the FDA and thoroughly understand its workings can also help ensure that sponsors have a positive experience. There is no substitute for expertise in regulatory affairs.