On December 13, President Barack Obama signed the 21st Century Cures Act. The landmark bi-partisan health and science bill, which passed the U.S. Senate by a vote of 94 to 5, provides $6.3 billion in funding over 10 years, including $4.8 billion to the National Institutes of Health in support of such programs as President Obama’s “Precision Medicine Initiative,” Vice President Biden’s “Cancer Moonshot,” and the “Brain Initiative.” It also directs over $1 billion in funding over the next two years to the states for opioid abuse prevention and treatment programs, and overhauls Federal policy on care for mental health issues.
Perhaps, most controversial, the Act provides a further $500 million to the U.S. Food and Drug Administration, and calls for “streamlining” the way the agency approves drugs and medical devices and easing regulation around new drug approvals. While how that will be achieved is not yet well defined, industry critics fear changes could undermine efforts to ensure that drugs and devices are safe and effective. In particular, the Act includes the provision of allowing for “real world” evidence to back a broader label, replacing clinical data with data summaries.
The new funding for NIH — while welcomed — is also subject to some uncertainty. Such funding, while authorized, is not guaranteed and needs to be appropriated by Congress each year. Additionally, the timeline for implementation of many of the initiatives included in the Act remains unknown, as few deadlines are laid out. For example, FDA is charged with establishing a new pathway for biomarkers and other drug development tools that can be used to shorten development times and reduce failures — but there is no date specified for this effort’s completion. As we have written, efforts aimed at identifying and validating biomarkers — at least in the immuno-oncology space — will be complex and costly process, as neither the content nor the platform for measuring IO biomarkers have been determined.