President Trump’s proposed FY 2018 Budget (a/k/a the “skinny budget”) presented a departure from his predecessor’s proposed annual budgets – namely a $54 billion increase in defense and military spending paired with corresponding cuts to virtually every other federal department. But one area President Trump did not cut was the implementation of the 21st Century Cures Act (the “Cures Act”), which also happens to be one of the last bills signed into law by then-President Obama.
The FY 2018 budget blueprint proposes to appropriate $1.1 billion towards the Cures Act’s implementation in the upcoming fiscal year. The Cures Act strives to expedite the discovery, development, and delivery of new treatments and cures. Those in the medical, biotechnology, and pharmaceutical industry should look to the Cures Act as the potential game-changer that the bipartisan sponsors of the law hoped it would be.
Not only does the Cures Act provide the National Institute of Health with significant new funds to speed up research into diseases like cancer and Alzheimer’s, but it also attempts to speed up the process by which new treatments are reviewed and approved by the FDA. The Cures Act also focuses on changes to the treatment of mental health and substance abuse. The reforms included in the Cures Act create a new Assistant Secretary for Mental Health and Substance Abuse to coordinate mental health programs, expand assisted outpatient treatment for children and adults, and direct the Department of Health and Human Services to issue guidance to clarify the role of HIPAA to ensure proper communications occur between providers, patients and their families.
The inclusion of funding in the “skinny budget” is just one of the many hurdles the Cures Act will face during its implementation phase. The President’s budget blueprint is unlikely to be enacted by Congress in its present form, and it remains to be seen what priorities Congress will seek to fund. Perhaps most important, and as we previously wrote about, President Trump’s Executive Order requiring two regulations be removed for every new regulation proposed will make the rulemaking process much more cumbersome for the Department of Health and Human Services, the Food and Drug Administration, and other agencies with responsibilities under the Cures Act.