FDA Reorganization to Accommodate the Collaborative Nature of Innovation

Innovation is becoming a highly collaborative effort. In recognition of this phenomenon, the U.S. Food and Drug Administration (FDA) is reorganizing the way it works.

Earlier this year, Professor Dacheng Ren from the College of Engineering at Syracuse University pointed out that most research conducted today is a result of multidisciplinary work. He saw the emergence of new fields of science, more accurately speaking, the collaboration of different sciences, like biotechnology or biochemistry. This shift also lead to changes in the way we regulate invention. Professor Ren and his team hold numerous patents and patent applications on inventions, including an innovative antimicrobial hydrogel to treat nosocomial infections. He has also worked closely with the FDA to promote antimicrobial research. After hearing his thoughts, I have been looking out for how changes in innovation has influenced the FDA. On June 4th, 2018, the FDA released a statement specifically addressing this matter.

The FDA has been approving many “first-of-its kind” drugs and medical devices for the past two years, such as the First-in-Class approval of a drug to treat relapsing forms of multiple sclerosis (Ocrevus), first gene therapy (Luxturna), and the first artificial iris (CustomFlex). Although new to the FDA, inventions of this nature have not been unfamiliar to the scientific community.

Changes in the innovative atmosphere are giving rise to entirely new categories of products that have never been contemplated before. There has been a shift from discovery-based invention to collaboration-based invention. This shift has been rapidly growing for the past decade, however only now has it become so evident. To accommodate this shift, the FDA is also innovating its approval process. To accommodate not only the advancement of the nature of innovation, but also the rate of development, the FDA needed to reorganize in order to create a more effective and efficient system.

What used to be an independent working environment is now changing into a collaborative one. There are currently groups of individuals with different backgrounds that are assigned to accessing a single FDA submission because there are few novel inventions today that can be categorized into just one category of study.

The statement released on June 4th was the Proposal of Process Modernization to Support New Drug Development. In this release, the Director of the FDA’s Center for Drug Evaluation and Research, Dr. Janet Woodcock wrote: “[b]oth science and technology are changing at a blistering pace and we need to keep up.” For example, the FDA approved a record high of 46 novel drugs last year. The key pillar for this drug approval modernization process is collaboration. The FDA already works with numerous organizations in the scientific, medical, and regulatory communities in its efforts to provide patients with safe and effective drugs. However, by promoting further collaboration within the FDA itself, the speed at which safe drugs can go from bench-side to bed-side can be greatly accelerated.

The proposal highlights six key focus areas: talent diversity, multidisciplinary teams, efficient operational structure, enhanced IT capabilities, emphasis on safety, and patient voice. The FDA already employs multidisciplinary teams of experts in various fields to tackle new applications, and the proposal suggests that there should be an enhancement and focus on these proven effective multidisciplinary teams to review applications from the get-go. She also recommends that the FDA integrate the various review processes employed by 19 separate review divisions into a single process as to better distribute the work between technical experts and regulatory experts. The proposal also emphasizes future recruitment efforts to attract talent with different backgrounds and experiences. The FDA would train the new talent so they become leaders who can promote the development of safe and effective drugs.

The key in the FDA’s modernization strategy is to promote efficiency while maintaining high safety standards. To emphasize this point, the proposal notes that there should be a unified post-market safety surveillance framework to facilitate drug safety throughout and beyond the drug approval process. Input from direct stakeholders is vital in promoting safety. By allowing patients to have more of a voice in the FDA process, the FDA can have a better idea on the key issues and the effectiveness of the process reorganization. At the end of the day, all effort is made to allow patients to have access to safe and effective drugs at a faster pace.

Not only is the FDA revamping the drug approval process, but Dr. Jeffrey Shuren is also leading a reorganization of the medical device approval process to conform to the rapid pace of innovation seen today. Advancements in technology have been solving problems which have been thought too risky to tackle such as the BrainPortV100 which helps blind individuals navigate through their surroundings by translating visual signals to sensations on the user’s tongue. However, there still requires a process to evaluate the safety and efficacy of these new devices. In recognition of this issue, Dr. Shuren identified 5 key areas of focus: establish a medical device and patient safety net, modernize post-market mitigations, promote the development of safe medical devices, enhance cybersecurity, and promote the collaboration of premarket and post-market offices as mentioned above. The ultimate goal is to promote patient access while protecting patient safety and security.

The FDA recognizes that “safety and innovation goes hand-in-hand.” Through the FDA’s modernization, patients will be able gain access to safe and effective drugs and medical devices at a faster pace, particularly those that address unmet needs. Today, innovation occurs through meeting of the minds. In tune, the regulation of innovation occurs through the collaboration. Innovation is stimulating a change in regulation, and in turn, a modernization of the regulatory process is promoting the speed of innovation.