By Jim Shehan, head of Lowenstein Sandler’s FDA Regulatory Practice and Donna Hanrahan, life science attorney, Lowenstein Sandler
Life sciences companies are navigating sweeping changes brought about by the 21st Century Cures Act (the “Cures Act” or the “Act”) signed in December 2016. Of most interest to those companies is how the Act is changing the pathways and processes for developing and getting approval for new drugs and devices and new uses for existing products.
The drug and device provisions of the Cures Act are designed to accelerate the discovery, development, and delivery of life-saving therapies. While the rhetoric of the new administration has been largely confined to speeding up FDA review of approval applications, knowledgeable industry veterans are well aware that current review times are historically fast and that the real opportunities to speed innovation lie in the development and testing phases that occur prior to FDA review. The Act therefore incorporates the long-standing desire of patient advocacy groups, drug and device manufacturers, and research organizations to modernize the regulation of drug and device development and minimize barriers to innovation that occur prior to submission of an application. But don’t expect most of these changes to occur soon — the Act allows the FDA several years to implement many of the most sweeping provisions and, on top of that, the FDA has a long tradition of missing deadlines set in legislation.