A new federal watchdog report is calling on agencies to improve their policies that govern the drug scheduling process\u2014including how they evaluate substances and develop recommendations.<\/p>\n
The new U.S. Government Accountability Office (GAO) report published on Wednesday comes as the federal government continues to consider whether to comprehensively reschedule marijuana under the Controlled Substances Act (CSA) to Schedule III as was recommended by the Department of Health and Human Services (HHS).<\/p>\n
In general, GAO found that the Drug Enforcement Administration\u2019s (DEA) scheduling decisions usually aligned with HHS and Food and Drug Administration (FDA) recommendations during the period of six years that it examined\u2014but that both agencies lack important procedures for carrying out their responsibilities and to ensure consistency in the process.<\/p>\n
\u201cWe found that DEA and FDA have some policies that address aspects of the scheduling process; however, these policies have gaps,\u201d the report said. \u201cFor example, DEA does not have any policies or procedures regarding how its staff are to conduct evaluations or schedule substances. In addition, FDA does not have policies or procedures specifying how its staff are to conduct evaluations or develop scheduling recommendations for substances.\u201d<\/p>\n
\u201cDEA does not have policies that assign roles and responsibilities related to scheduling substances, and neither DEA nor FDA have policies that describe the specific procedures staff should follow for fulfilling their responsibilities related to preparing scheduling evaluations and recommendations.\u201d<\/p>\n
GAO said DEA specifically is lacking policies that identify roles, responsibilities and procedures for<\/p>\n
FDA, for its part, does not have policies or procedures that:<\/p>\n
\u201cThese policies have gaps that may pose a risk to the consistency of DEA\u2019s and FDA\u2019s future operations in the event of staff turnover or any other disruption that could lead to a loss of institutional knowledge,\u201d the report said.<\/p>\n
GAO noted that an FDA memorandum of understanding with the National Institutes of Health\u2019s (NIH) National Institute on Drug Abuse (NIDA) that describes procedures for consulting on scheduling recommendations is over 40 years old and, as such, is \u201coutdated because it does not reflect the current entities involved or procedures.\u201d<\/p>\n
GAO is making three recommendations to improve the drug scheduling process:<\/p>\n
The watchdog said that the Department of Justice, DEA, HHS, FDA and NIH have all agreed with the recommendations.<\/p>\n
Depending on the process through which a drug is being scheduled\u2014via administrative scheduling, new drug application scheduling, temporary scheduling, international treaty scheduling through domestic scheduling orders or legislation\u2014DEA is sometimes required to consider recommendations and medical and scientific evaluations from HHS.<\/p>\n
During the period GAO examined\u20142020 through 2025\u2014DEA was required to do so for 95 of the 208 substances for which the agency took scheduling actions, and it did so 100 percent of the time. The agency\u2019s final scheduling decision aligned with HHS recommendations for all 84 substances for which it published a final scheduling decision, while the remaining 11 were still subject to extended temporary scheduling orders.<\/p>\n
DEA and FDA officials told GAO that \u201cdifferences of scientific opinion between the two agencies about a substance\u2019s schedule are rare, but they have occurred,\u201d the report said. \u201cIn such cases, they typically discuss their differences, share data and other information, and resolve any differences before DEA solicits public comments.\u201d<\/p>\n
GAO said that it conducted the new evaluation because \u201cmembers of Congress have raised questions and concerns about how DEA considers scientific and medical evaluations and scheduling recommendations from HHS when making its decisions.\u201d<\/p>\n
\u201cA substance\u2019s schedule and quantity control the extent to which criminal penalties under the Controlled Substances Act may be levied regarding its illegal manufacturing, distribution, or possession. In recent years, members of the public, interest groups, and elected officials have raised questions about how certain substances are scheduled under the act.\u201d<\/p>\n
\u201cFor example, substances such as marijuana have been legalized in some states for medical use,\u201d the report said, noting that Attorney General Todd Blanche in April issued an order immediately moving\u00a0marijuana products regulated by a state medical cannabis license from Schedule I<\/a> of the CSA to Schedule III, along with marijuana products that are approved by the Food and Drug Administration (FDA).<\/p>\n A DEA hearing that recently concluded testimony is\u00a0considering broader marijuana rescheduling<\/a>.<\/p>\n The GAO report<\/a> included an appendix focused on the ongoing cannabis rescheduling process, and noted that it involved a new two-part test to evaluate marijuana\u2019s medical value was sanctioned by the Department of Justice Office of Legal Counsel.<\/p>\n \u201cIn April 2024, the Department of Justice Office of Legal Counsel issued an opinion related to questions on the potential rescheduling of marijuana. One issue addressed by the Office of Legal Counsel was whether a substance that satisfies HHS\u2019s two-part inquiry was sufficient to establish a currently accepted medical use under the statute, even if the substance has not been approved by the FDA and does not satisfy DEA\u2019s five-part test. According to the Office of Legal Counsel, DEA\u2019s approach to determining whether a substance had a currently accepted medical use was an impermissibly narrow interpretation of the Controlled Substances Act and that satisfying HHS\u2019s two-part inquiry was sufficient to establish a substance had a currently accepted medical use. This was still the case, even if the substance had not been approved by the FDA and did not satisfy DEA\u2019s test.\u201d<\/p>\n That office, it noted, also determined that moving cannabis to Schedule III would not violate the U.S.\u2019s international treaty obligations.<\/p>\n A DEA administrative law judge is currently considering testimony in the marijuana rescheduling hearing. After he issues a recommendation, DEA Administrator Terrance Cole will make the final determination on whether cannabis is comprehensively moved to Schedule III.<\/p>\n That said, the marijuana rescheduling process is being challenged with several lawsuits<\/a>\u00a0that have been consolidated by a federal appeals court. Those pieces of\u00a0litigation against the cannabis reform have been filed by state attorneys general<\/a>,\u00a0marijuana legalization opponents<\/a>\u00a0and a\u00a0cannabis-focused biopharmaceutical corporation<\/a>.<\/p>\n The U.S. Court of Appeals for the District of Columbia Circuit recently\u00a0rejected a drug testing industry association and a pharmaceutical company\u2019s request to block the Trump administration from moving forward with cannabis rescheduling<\/a> while the litigation is considered.<\/p>\n The post Federal Watchdog Agency Says Drug Scheduling Process Has \u2018Gaps\u2019 As DEA\u2019s Marijuana Review Continues<\/a> appeared first on Marijuana Moment<\/a>.<\/p>\n
A new federal watchdog report is calling on agencies to improve their policies that govern the drug scheduling process\u2014including how they evaluate substances and develop recommendations. The new U.S. Government Accountability Office (GAO) report published on Wednesday comes as the federal government continues to consider whether to comprehensively reschedule marijuanaContinue Reading<\/a><\/span><\/p>\n","protected":false},"author":459,"featured_media":0,"comment_status":"false","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[18,81],"tags":[],"_links":{"self":[{"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/posts\/86990"}],"collection":[{"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/users\/459"}],"replies":[{"embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/comments?post=86990"}],"version-history":[{"count":1,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/posts\/86990\/revisions"}],"predecessor-version":[{"id":86991,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/posts\/86990\/revisions\/86991"}],"wp:attachment":[{"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/media?parent=86990"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/categories?post=86990"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/tags?post=86990"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
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\nRead More: Federal Watchdog Agency Says Drug Scheduling Process Has \u2018Gaps\u2019 As DEA\u2019s Marijuana Review Continues<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"