FDA Head Califf Lays Out Biopharma Prioritization Gameplan

Recently appointed to his second term as the FDA’s commissioner, Dr. Robert Califf has been straightforward about his priorities for the agency and its mission in guiding public health solutions past the goal line. Now, Califf has called on the biopharma industry to laser focus on treatments for persistent population wellness issues such as chronic illness and addiction.

“Existing approaches to develop and assess pharmacologic therapies, medical devices, and interventions for [common chronic diseases] and addiction, including behavioral techniques, should be reexamined by the biomedical community,” said Califf. In terms of success stories, as well as examples to live up to, he pointed to significant improvements in the treatment of cystic fibrosis, Type-1 diabetes, and multiple myeloma that stemmed from greater collaboration and communication between parties in the companies-regulators-patients pipeline.

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Putting his money where his mouth is, Califf has steered the FDA into an agreement with the NIH and its grantees to subsidize new research efforts. Also collaborating in this undertaking will be a new player, the currently leader-less Advanced Research Projects Agency for Health.

Califf has also sounded off on the importance of digital data integration for research and clinical care, but cautioned that “attention to cyberattack vulnerability” is critical to protecting as well as streamlining better digital infrastructure.