Latest news with #RighttoTryAct
Yahoo
06-06-2025
- Health
- Yahoo
US state passes law allowing experimental drugs to be prescribed – a model for the future?
The US state of Montana has become the first in the country to let patients try experimental drugs – even if they are not terminally ill. The new law allows doctors to refer patients to licensed 'experimental treatment centres', where they can access drugs that have only passed phase 1 clinical trials – the earliest stage of testing in humans. This goes far beyond existing federal law, which only allows terminally ill patients to access such drugs under the Right to Try Act, passed in 2017. Montana already had a fairly permissive right to try law, which was originally designed to let terminally ill patients access treatments that hadn't yet received full approval by the drug regulator. In 2023, that law was expanded to include patients with any medical condition. The latest law goes even further, creating a formal system for clinics to offer these experimental treatments. According to an article in MIT Technology Review, the new law was shaped and promoted by a group of longevity advocates – a mix of scientists and influencers who are focused on extending human life. Get your news from actual experts, straight to your inbox. Sign up to our daily newsletter to receive all The Conversation UK's latest coverage of news and research, from politics and business to the arts and sciences. Before new medicines reach the market, they usually go through several stages of testing. A phase 1 trial is the first step in human studies and is designed to find a safe dose and spot early side-effects. It typically involves a small group – between 20 and 100 people – and does not prove the drug works. Only around 12% of drugs that enter phase 1 trials go on to gain full approval. Many fail due to safety issues or lack of effectiveness. Montana's new law allows access to these early-stage treatments with a doctor's recommendation – even for patients who are not terminally ill. Clinics must be licensed as experimental treatment centres, and 2% of their profits must be used to help low-income patients access these therapies. Supporters say it gives people more control over their own health and could help boost innovation in areas like cancer, neurodegenerative disease and age-related decline. There is also hope it could turn Montana into a destination for medical tourism, attracting biotech investment. But critics warn that the move could put vulnerable patients at risk. Drugs in phase 1 trials may be safe enough to test – but their long-term effects are still unknown, and they may not work. There are also concerns over whether insurers will cover complications, since the drugs are not approved. Legal protections for both patients and doctors remain unclear. Elsewhere in the world, access to experimental drugs is more tightly controlled. In the UK, experimental drugs are usually only available through formal clinical trials or special 'compassionate use' requests – all subject to strict oversight by regulators like the Medicines and Healthcare products Regulatory Agency and the Health Research Authority. The same applies across the EU, where compassionate use is typically limited to drugs in later stages of testing. Japan has a similar system, called 'expanded access clinical trials', which also limits use to drugs already in phase 2 or beyond. And in South America, some countries allow patients to keep receiving experimental drugs after trials end – but not to start them outside of a trial. Montana's decision marks a bold new approach in the continuing debate over patient rights. It raises big questions about safety, ethics, regulation and the role of government in balancing innovation with public health. It could end up being a model for other states – or a cautionary tale. This article is republished from The Conversation under a Creative Commons license. Read the original article. Dipa Kamdar does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.
Yahoo
30-03-2025
- Business
- Yahoo
DEA Forces Marijuana Pharma Drug Industry Offshore: A Symbol of DEA Systemic Obstruction Against Trump Administration Directives
"The DEA's marijuana approach is stuck in an outdated 'war on drugs' mentality," said Duane Boise CEO of MMJ International Holdings. "While lawmakers push for medical progress, the DEA's red tape is suffocating innovation." DEA officials, including Matt Strait and Thomas Prevoznik, have been accused of imposing unnecessary hurdles, such as slow-walking API Bulk Manufacturing registrations, and imposing opaque approval processes while patients continue to suffer. WASHINGTON, DC / / March 30, 2025 / As the Trump administration pushes to reshore pharmaceutical manufacturing through aggressive tariffs and trade policies, a less visible but equally critical challenge persists: the Drug Enforcement Administration's (DEA) stringent regulations. Critics argue that the agency's bureaucratic delays and restrictive oversight are not only hindering medical research but also driving pharmaceutical companies overseas , undermining domestic innovation and economic goals. The MMJ Marijuana Case: A Symbol of DEA Systemic Obstruction At the heart of this debate is a high-stakes legal battle between MMJ International Holdings and the DEA . The company, which specializes in cannabis-based treatments for conditions like multiple sclerosis and Huntington's disease , alleges that the DEA has unlawfully delayed approvals for cultivating proprietary marijuana strains needed for research and drug development. These delays, MMJ claims, have delayed FDA clinical trials for its flagship drug, MMJ-002, and reflect a broader bias against cannabis-derived medicines. The lawsuit also challenges the constitutionality of protections for Administrative Law Judges (ALJs), who oversee DEA cases. MMJ argues that these protections insulate ALJs from accountability, allowing inefficiency and bias to fester. The Department of Justice (DOJ) recently backed this view, declaring ALJ removal safeguards unconstitutiona l - a move that will force the DEA to operate with greater transparency and responsiveness. Regulatory Delays vs. Legislative Progress The DEA's actions stand in stark contrast to recent legislative efforts aimed at advancing medical research. Laws like the Right to Try Act and the Medical Marijuana Research Expansion Act were designed to streamline access to experimental treatments and expand cannabis studies. However, DEA officials, including Matt Strait and Thomas Prevoznik , have been accused of imposing unnecessary hurdles, such as slow-walking cultivation licenses and imposing opaque approval processes. "The DEA's approach is stuck in an outdated 'war on drugs' mentality," said Duane Boise CEO of MMJ International Holdings. "While lawmakers push for medical progress, the agency's red tape is suffocating innovation." DEA Driving Pharma Offshore The DEA's sluggish processes are exacerbating a growing trend: pharmaceutical companies relocating operations to countries with friendlier regulatory climates. Canada, Germany, and Israel-nations with clearer pathways for cannabis research-have emerged as hubs for drug development, luring American firms deterred by U.S. bureaucracy. "Every month of delay costs millions and risks losing talent overseas," noted a CEO of a biotech startup. "The DEA's inefficiency is a competitive disadvantage for the U.S." Broader Implications for DEA Accountability MMJ's case could set a precedent for reforming how federal agencies operate. If the court sides with MMJ, agencies like the DEA will face increased executive oversight, potentially dismantling systemic inefficiencies. This shift could revitalize sectors reliant on timely approvals, including pharmaceutical manufacturing, and biotechnology. The Cannabis Conundrum Critics argue that the DEA's resistance to cannabis research is particularly shortsighted. With 38 states legalizing medical marijuana and global markets for cannabis-based therapies projected to reach $55 billion by 2027, the U.S. risks ceding leadership in a burgeoning industry. "The DEA is clinging to stigma over science," said Duane Boise an advocate for Pharmaceutical marijuana. "Patients are paying the price." A Crossroads for U.S. Pharma and Marijuana Drug Development The outcome of MMJ's lawsuit could determine whether the U.S. retains its edge in pharmaceutical innovation. A win for MMJ International Holdings will catalyze regulatory reforms, aligning the DEA with legislative and public sentiment. Conversely, a loss could accelerate the offshoring of research and production, leaving American patients dependent on foreign-developed treatments. As the Trump administration champions "America First" trade policies, the DEA's role as an inadvertent roadblock highlights a stark contradiction . Without regulatory modernization, tariffs alone may fail to reverse the pharmaceutical exodus-or unlock the potential of groundbreaking therapies. The Bottom Line: The DEA's regulatory inertia is more than a bureaucratic hiccup; it's a critical threat to U.S. medical innovation and economic competitiveness. As legal and political battles unfold, the agency's ability to adapt may well decide the future of American pharmaceutical leadership. For updates on this evolving story and its impact on cannabis research and federal accountability, follow our ongoing coverage. MMJ is represented by attorney Megan Sheehan . CONTACT: Madison Hisey mhisey@ 203-231-8583 SOURCE: MMJ International Holdings View the original press release on ACCESS Newswire
