Latest news with #FDA-sanctioned
Yahoo
04-05-2025
- Business
- Yahoo
DEA Diversion in Cannabis Chaos: MMJ Urges Terrance Cole, President Trump DEA Nominee to Dismantle Biden Era Cannabis Obstructors
Message to President Trump's Appointee: Terrance Cole Must Act on Cannabis Scientific Reform. "Mr. Cole has a historic opportunity to lead with integrity, science, and constitutional fidelity," said Boise. "He must put an end to this unlawful administrative hearing, root out DEA institutional marijuana bias, and restore lawful science-based regulatory practices." WASHINGTON, DC / / May 4, 2025 / MMJ BioPharma Cultivation announced it will file an emergency motion and lawsuit in the U.S. District Court for the District of Rhode Island following a controversial ruling by DEA Administrative Law Judge (ALJ) Teresa Wallbaum. Judge Wallbaum recently issued a ruling to vacate a previously granted stay-clearing the path for a DEA ALJ hearing before what MMJ asserts is a constitutionally defective tribunal. Judge Wallbaum retired immediately after issuing the ruling. The company's forthcoming legal action seeks to block the DEA's internal administrative hearing process, which MMJ argues violates the Supreme Court's landmark ruling in Axon Enterprise, Inc. v. FTC, and inflicts irreparable harm on its constitutional rights and medical mission. MMJ Direct Challenge to DEA Overreach The Axon decision, issued by the Supreme Court in 2023, affirmed that entities subject to unconstitutional agency proceedings can challenge them in federal court before being forced through the flawed administrative process. MMJ contends that the DEA's ALJ system, where judges are insulated from presidential oversight, runs afoul of Article II of the Constitution. "We are not just challenging DEA policy; we are defending the rule of law," said Duane Boise, CEO of MMJ BioPharma Cultivation. "The DEA cannot ignore Supreme Court precedent and funnel applicants into hearings that are constitutionally invalid." From Regulatory Delay to Constitutional Injury MMJ's application to grow pharmaceutical-grade marijuana for FDA-sanctioned clinical trials was filed in 2018. Since then, the company has: Built and passed inspection of a DEA-compliant facility Received a DEA Schedule I analytical registration Filed two FDA Investigational New Drug (IND) applications Been awarded FDA Orphan Drug Designation for Huntington's Disease Despite these milestones and the 60-day processing deadline set by the Medical Marijuana and Cannabidiol Research Expansion Act (MCREA), MMJ has waited over 2,300 days. "The damage done by these delays is not just procedural-it's personal," Boise added. "Patients living with Huntington's and MS deserve answers and access, not bureaucratic purgatory." Biden's Failed Cast of Characters: Milgram, Garland, Thomas Prevoznik, Matthew Strait For years, DEA Administrator Anne Milgram, Attorney General Merrick Garland, and the broader Biden administration have stood idle-overseeing a federal agency that continues to delay and deny legitimate medical cannabis research. Despite bipartisan legislation and judicial precedent, no meaningful reform has occurred. "The Biden administration had every opportunity to fix this. Instead, they turned a blind eye to patients and the Constitution," said Boise. Message to President Trump's Appointee: Terrance Cole Must Act Now, all eyes turn to Terrance Cole, President Trump's nominee for DEA Administrator, who MMJ urges to dismantle the obstructionist legacy left behind by the Biden-era leadership. "Mr. Cole has a historic opportunity to lead with integrity, science, and constitutional fidelity," said Boise. "He must put an end to this unlawful administrative hearing, root out DEA institutional bias, and restore lawful science-based regulatory practices." MMJ emphasized that Cole's leadership can mark a turning point: not just for the agency, but for tens of thousands of patients across the country. "This is about reclaiming the DEA from the grip of politics and putting patients first," Boise added. "Terrance Cole can either reform the agency-or risk continuing the shameful legacy of his predecessors." Federal Court Relief Sought MMJ's legal filing will request: A preliminary and permanent injunction halting the ALJ proceeding A declaration that the DEA's ALJ process violates the Constitution Expedited federal review in accordance with the Axon precedent "We are not seeking special treatment," Boise concluded. "We are demanding a fair, lawful process-something every American is entitled to. The DEA must be held accountable." MMJ is Represented by Attorney Megan Sheahan and Associates CONTACT:Madison Hiseymhisey@ SOURCE: MMJ International Holdings View the original press release on ACCESS Newswire
Associated Press
05-03-2025
- Health
- Associated Press
NCH Appoints Dr. Patrick Smith as President of the Board of Directors of HSS at NCH Kapnick Ambulatory Surgical Center
/ -- Naples Comprehensive Health (NCH) is pleased to announce the appointment of Patrick A. Smith, MD, as the new President of the Board of Directors of HSS at NCH Kapnick Ambulatory Surgical Center. Dr. Smith brings over three decades of experience in orthopedic surgery and sports medicine to this leadership role. A Michigan native, Dr. Smith graduated with honors from the University of Michigan, where he also earned his medical degree. He completed both his surgical internship and orthopedic residency at the University of Michigan Medical Center. Following his residency, Dr. Smith pursued a one-year sports medicine fellowship under the mentorship of Jack C. Hughston, MD, at the Hughston Clinic in Columbus, Georgia. Dr. Smith is board certified by the American Board of Orthopedic Surgery and holds a subspecialty certification in Sports Medicine. In 1986, Dr. Smith joined the Columbia Orthopedic Group in Columbia, Missouri, specializing in arthroscopic surgery and sports medicine. He served as Head Team Physician for the University of Missouri for 30 years and was instrumental in the care of athletes at the college. In recognition of his contributions, the training center at the University of Missouri football field was renamed the Patrick A. Smith Sports Medicine Center in his honor. Throughout his career, Dr. Smith has been extensively involved in orthopedic research, publishing in numerous peer-reviewed journals. He conducted the first FDA-sanctioned study on the use of platelet-rich plasma to treat knee osteoarthritis and has been a pioneer in the use of internal bracing for anterior cruciate ligament (ACL) repair and reconstruction. Currently, he is engaged in clinical studies focusing on essential factors for rotator cuff healing. 'Dr. Smith's expertise, research, and deep commitment to patient care make him an invaluable addition to HSS at NCH,' said Paul Hiltz, President and CEO of NCH. 'His leadership will further our mission to provide world-class orthopedic care to our community, elevating the level of treatment available in Southwest Florida.' 'I am honored to join HSS at NCH and be part of a team dedicated to delivering world-class orthopedic care,' said Dr. Smith. 'Throughout my career, my passion has been advancing innovative treatments that improve patient outcomes, and I look forward to bringing that same commitment to Naples.' Dr. Smith's passion for patient care and his openness to innovative procedures and technologies have been hallmarks of his career. His leadership is expected to further enhance the quality of orthopedic care at HSS at NCH. About NCH NCH (Naples Comprehensive Health) is an Advanced Community Healthcare System™ serving Southwest Florida with premier routine, critical, and specialty care. NCH, a locally governed non-profit, is recognized as one of Healthgrades America's Top 50 Hospitals which puts it in the top 1% in the nation for clinical excellence, in addition to being named a Top 50 Hospital for Surgical Care. The system is more than just two hospitals (referred to as the NCH Baker Hospital and NCH North Hospital) with a total of 713 beds - NCH is an alliance of over 750 physicians and medical facilities in dozens of locations throughout Southwest Florida and is the region's only Joint Commission accredited Comprehensive Stroke Center. NCH cardiac care is ranked top-3 in the state by Healthgrades. NCH collaborates with the Hospital for Special Surgery for orthopedics, Nicklaus Children's Hospital for pediatrics, and ProScan Imaging for radiology services, ensuring top-tier medical care is available in Southwest Florida. With the largest provider network, urgent/immediate care centers, diagnostic facilities, and two hospitals, NCH is always advancing the quality of care near you. For more information, visit About HSS HSS is the world's leading academic medical center focused on musculoskeletal health. At its core is Hospital for Special Surgery, nationally ranked No. 1 in orthopedics (for the 15th consecutive year), No. 3 in rheumatology by U.S. News & World Report (2024-2025), and the best pediatric orthopedic hospital in NY, NJ and CT by U.S. News & World Report 'Best Children's Hospitals' list (2023-2024). In a survey of medical professionals in more than 20 countries by Newsweek, HSS is ranked world #1 in orthopedics for a fourth consecutive year (2025). Founded in 1863, the Hospital has the lowest readmission rates in the nation for orthopedics, Amanda Lucey NCH +1 239-460-7318 Legal Disclaimer:
