Health Law Advisor

The latest attempt to expand the psychedelic world is making its way through Congress. On September 21, 2023, Congressmen Robert Garcia (CA-42)  and Earl Blumenauer (D-OR) introduced the “Validating Independence for State Initiatives on Organic Natural Substances Act of 2023”. Aptly titled the VISIONS Act, this legislation would, if enacted, protect legal psilocybin use from federal law enforcement intervention in any state or locality where psilocybin is legally permitted. The language in the Act specifically states that it aims to prohibit any federal funds from being ...

On Friday, October 6, 2023, the Drug Enforcement Administration (“DEA”) and Department of Health and Human Services (“HHS”) filed a Second Temporary Extension of the COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications (“Second Temporary Rule”), extending the full set of telemedicine flexibilities adopted during the COVID-19 public health emergency (“PHE”) through December 31, 2024. The Second Temporary Rule is scheduled for publication in the Federal Register today (October 10, 2023) and scheduled to take effect on November ...

On August 30, an official at the United States Department of Health and Human Services (HHS) released one of the most significant announcements made at the federal level concerning marijuana reclassification. In a letter dated August 29, 2023, Rachel Levine (HHS Assistant Secretary for Health), provided a formal recommendation to Anne Milgrim (Agency Administrator) at the United States Drug Enforcement Agency (DEA) to reclassify cannabis from a Schedule I drug to a Schedule III drug under the Federal Controlled Substances Act (CSA).

A DEA spokesperson confirmed the department ...

On August 4, 2023, the Drug Enforcement Administration (“DEA”) announced plans to host two public listening sessions, scheduled to take place on September 12 and 13, 2023 at DEA’s headquarters in Arlington, VA, to collect additional input regarding the practice of telemedicine and specifically the remote prescribing of controlled substances without conducting an in-person evaluation of patients before prescribing.

The listening sessions will be open to the public, and those who anticipate attending must register through DEA’s Diversion Control website. The registration process opens today (August 7, 2023). DEA also plans to make the listening sessions available via livestream and copies of transcripts from the sessions also will be made available at a later date on the DEA Diversion Control Program website.

On February 24, 2023, the Drug Enforcement Agency (“DEA”) announced proposed permanent rules around prescribing controlled substances via telemedicine that expand the circumstances under which practitioners can prescribe controlled substances without first conducting an in-person medical evaluation of the patient outside of the COVID-19 public health emergency (“PHE”). The proposed rules are more restrictive than the DEA emergency waivers under which providers conducted telemedicine prescribing for the last three years, but are less restrictive in comparison to the pre-PHE regulations applicable to telemedicine prescribing of controlled substances under the federal Controlled Substances Act (“CSA”).

Both the proposed rules related to telemedicine prescribing of Schedule III-V non-narcotic controlled substances, and the separate proposed rules related to telemedicine prescribing of buprenorphine, were published in the Federal Register on March 1, 2023. The public has been given until March 31, 2023 to review and provide comments regarding the proposed rules, which the DEA will consider before promulgating final regulations.

The Food and Drug Administration (FDA) recently issued both draft and final guidance regarding food allergen labeling requirements.  The draft guidance document, Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5), updates the previous (fourth) edition with new and revised guidance concerning food allergen labeling. FDA also issued a final guidance document with the same title in order to preserve questions and answers that were unchanged from the previous (fourth) edition, which was published in 2004 and last updated in 2006.

On January 24, 2023, FDA published a notice in the Federal Register entitled, “Clarification of Orphan-Drug Exclusivity Following Catalyst Pharms., Inc. v. Becerra.”[1]  In brief, the Catalyst decision by the 11^th Circuit Court of Appeals[2] concerned FDA’s application of the Orphan Drug Act (21 USC 360cc(a)), and in particular the extent of the 7-year orphan drug market exclusivity (ODE) provided with an orphan drug’s approval. The ODE, per the Orphan Drug Act prevents FDA from approving another applicant’s same drug for “the same disease or condition.”

Much like the ambiguous landscape involving cannabidiol (CBD) products on the consumer market, an influx of delta-8 THC containing products for consumption has highlighted a recurrent regulatory issue surrounding the legality of hemp derived products at the federal level. The Agricultural Improvement Act of 2018 (the “2018 Farm Bill”), which, among other things, offered a federal definition of hemp and removed it from the list of Schedule I controlled substances, specifically carved out hemp derived products with less than 0.3% delta-9-tetrahydocannabinol (THC) on a dry weight basis, thereby allowing products that meet this definition to flood the consumer markets.

On April 11, 2022, the Drug Enforcement Administration (DEA) released a final rule which amends DEA regulations to now require all applications for DEA registrations, and renewal of those registrations, to be submitted online. The final rule is effective May 11, 2022.

On January 7, 2021, DEA published a notice of proposed rulemaking (NPRM) that proposed requiring that all applications for DEA registrations, and renewal of those registrations, be submitted online. DEA is promulgating this rule as proposed in the NPRM with one exception: DEA is clarifying that Automated Clearing House (ACH) fund transfers will be accepted as payment for registrations and renewals.