In Virginia’s 2019 General Assembly (GA) Session, five of six proposed cannabis-related bills passed and will soon reach the desk of the Governor, ushering in some significant changes to the Commonwealth’s medical cannabis program. Among them, allowing full therapeutic-strength medical cannabis preparations, and the addition of physician assistants and nurse practitioners to the list of providers permitted to make medical cannabis recommendations.
On December 12, 2018, Congress passed the 2018 Farm Bill (The “Agriculture Improvement Act of 2018” or the “Bill”), which includes provisions that exempt Cannabis plants with lower than 0.3% THC content (also called “Hemp”) from the Controlled Substances Act (CSA). Once signed into law, the Farm Bill effectively legalizes the production, commercialization, and interstate shipment and sale of hemp and hemp-derived products like cannabidiol or “CBD”. Each state (including Indian Tribes and U.S. Territories) will eventually be able to regulate hemp production like any other agricultural commodity, as long as the U.S. Department of Agriculture (USDA) approves its plan to monitor and regulate the plant’s production.
The Cures Act is aimed at modernizing and personalizing healthcare by encouraging innovation and streamlining the process for discovery, development, and delivery of new treatments and technologies to those suffering from illness. Importantly, the legislation provides for significant funding to advance these goals, to the tune of $4.8 billion to the National Institutes of Health ("NIH"), $500 million to the Food & Drug Administration ("FDA"), and $1 billion in grants to states for opioid abuse prevention and treatment. This article will provide an overview of key components of the Cures Act and highlight implications for the future of healthcare.
The U.S. Food and Drug Administration is currently accepting requests from medical software developers to participate in a precertification pilot program that is scheduled to begin September 1, 2017. The program is aimed at developing precertification criteria for software companies that would allow approved companies to engage in a streamlined premarket review process for certain digital health products. The FDA will accept up to nine participants for the pilot program, which the Agency says will include both large, established software developers and small startup companies.