HEALTH & LIFE SCIENCES NEWS
HEALTH & LIFE SCIENCES NEWS
Exploring Critical Business and Legal Issues across the Healthcare and Life Sciences Industries
HEALTH & LIFE SCIENCES NEWS
Exploring Critical Business and Legal Issues across the Healthcare and Life Sciences Industries
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Doctor-Patient Relationships and Medical Marijuana: Where Are We Now?

On December 2, 2022, President Joseph Biden signed the Medical Marijuana and Cannabidiol Research Expansion Act (Cannabis Research Act), which provides a mechanism for industry and academia to access and research cannabis, including marijuana and other cannabis-derived products without violating the Controlled Substances Act (CSA). The Cannabis Research Act creates a pathway for researchers to register with the US Department of Justice to legally conduct scientific research on such products subject to certain requirements. The act also creates a system to allow drug manufacturers to legally produce products approved by the US Food and Drug Administration (FDA) that contain cannabidiol (CBD) or marijuana for commercial sale. Of particular significance for healthcare providers, the Cannabis Research Act also includes a doctor-patient relationship provision that permits state-licensed physicians to discuss the “currently known potential harms and benefits of marijuana and its derivatives, including cannabidiol, which may be derived from marijuana or other cannabis products such as hemp, as a treatment.”

The full provision is provided below:

  • SEC. 301. DOCTOR-PATIENT RELATIONSHIP.
    It shall not be a violation of the Controlled Substances Act (21 U.S.C. 801 et seq.) for a State-licensed physician to discuss—(1) the currently known potential harms and benefits of marijuana derivatives, including cannabidiol, as a treatment with the legal guardian of the patient of the physician if the patient is a child; or (2) the currently known potential harms and benefits of marijuana and marijuana derivatives, including cannabidiol, as a treatment with the patient or the legal guardian of [...]

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FDA 2019 Year in Review

2019 was a robust year for the US Food and Drug Administration’s (FDA’s) regulatory agenda. The agency continued to implement initiatives and mandates required by the 21st Century Cures Act (Cures Act), and navigated leadership and staffing changes at many levels. Most notably, Commissioner Scott Gottlieb resigned on April 5. Norman Sharpless and Brett Giroir served as acting interim commissioners following Commissioner Gottlieb’s resignation. On December 17, Congress swore in Commissioner Stephen Hahn, a radiation oncologist and former chief executive of MD Anderson Cancer Center.

This Special Report reviews notable actions that shaped FDA-regulated industries and products last year, and offers insight into the agency’s 2020 priorities and expected actions in a number of areas, including:

  • Digital health;
  • Streamlined product approvals;
  • Evolving evidentiary thresholds for product approvals;
  • Strategic enforcement;
  • And much more.

Click here to read the full report. 




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