Newly appointed Commissioner of Food and Drugs Robert M. Califf, M.D., recently wrote an article on his goals for the Food and Drug Administration (FDA) during his tenure. The article goes through Dr. Califf’s most important goal and responsibility, as well as other important goals that will remain front and center for awhile.
According to Dr. Califf, his most important responsibility is “to encourage and support a professional environment that enables our remarkably dedicated workforce to thrive and to reach its fullest potential.” He believes that we are in the midst of an “era of rapid change,” especially with the dramatic advances in biotechnology and information sciences.
Dr. Califf further believes in the importance of helping the FDA make effective decisions, even when optimal evidence and information is not available. This may mean making changes to adapt national and global systems of evidence generation to meet challenges and opportunities that tend to be presented by technological advances. Dr. Califf mentions that protecting the well-being of patients and consumers is the FDA’s responsibility and that the FDA must continue to keep pace with state of the art changes that are happening that have an effect on the needs and choices patients have. This can be done by “incorporating the best methods for taking patient preferences, experiences, and outcomes into account in every part of [the FDA’s] work.
Dr. Califf also places high importance on working with partners to build and sustain an infrastructure that produces that high quality scientific evidence needed to guide the FDA’s decisions about drugs, medical devices, tobacco products, and food products it is charged with regulating, in addition to decisions that healthcare providers, patients, and consumers make about individual health and well-being.
In addition to his highly-importance goal of making scientific evidence more easily attainable, Dr. Califf has several other goals that are on his “front burner” and “will remain there for the foreseeable future.”
One hot topic Dr. Califf mentioned in his goal list is to play a role in halting the growing epidemic of opioid abuse. The FDA has an Action Plan, which Califf plans to keep in force, including to-do list items such as: expand the use of advisory committees, strengthen postmarket requirements; update the Risk Evaluation and Mitigation Strategy (REMS) Program; and to expand access to abuse-deterrence formulations (ADFs) to discourage abuse.
Also on Califf’s list is the implementation of the FDA Food Safety Modernization Act (FSMA), a statutory directive to transform the food safety system. Dr. Califf plans to lend support in the form of applying cutting-edge analytical and biological science.
Yet another goal is an idea that just about every agency head has had over the past several decades, but few, if any, have achieved: interagency effectiveness. For his tenure, Dr. Califf has decided to continue the FDA-NIH Joint Leadership Council and the FDA-CDC meetings, as well as initiated similar discussions with CMS. Dr. Califf believes that the Biomarkers, Endpoints and other Tools (BEST) Resource serves as a powerful example of the ability of the FDA and NIH to contribute and solve regulatory issues together.
While the aforementioned goals are laudable, they do not signal all of Dr. Califf’s hopes and dreams for his tenure as FDA Commissioner. Even still, it is interesting that in his list of priorities, Dr. Califf makes no mention of promised guidance on off-label promotion. As we have mentioned many times before, such a failure to mention could be due to myriad reasons, including the fact that the FDA has been on the losing side of too many off-label cases as of late, or that the framework they are dealing with is so outdated, putting any energy into off-label promotion cases is not worth it. But without guidance most companies will continue to follow the narrow path previously laid out by the FDA.