From headlines and social media, psychedelic therapies, cannabis use and GLP-1 medications have seemingly become commonplace overnight, but the science underlying these treatments and the pathway to drug approval is often more nuanced than the headlines suggest.
In the following Q&A, Penn State researchers discussed the safety and availability of popularized drugs, what it takes for a new drug to be approved by the Food and Drug Administration (FDA) and what changes in drug policy mean for everyday Americans.
Q: With hearings by the Drug Enforcement Agency (DEA) on the proposed rescheduling of marijuana to Schedule III status concluded recently, what does that shift mean in practical terms?
Daniel Mallinson, associate professor of public policy and administration at Penn State Harrisburg, is an expert in local and state politics and policy, particularly in Pennsylvania. He also studies cannabis policy including efforts around marijuana legalization.
Mallinson: Medical marijuana was recently rescheduled to Schedule III of the Controlled Substances Act, meaning that the federal government now recognizes marijuana as having medical value with low dependence risk. That said, the change has not created a national market for medical marijuana, so state medical marijuana regulations still rule the day.
While the DEA is considering moving marijuana completely to Schedule III, that will not legalize state recreational programs. Schedule III drugs are still controlled substances that require prescription by an FDA-registered physician.
Q: Now that medical cannabis has moved to Schedule III, will that make medical research easier? Beyond research, what does this mean for cannabis businesses?
Mallinson: Rescheduling marijuana to Schedule III removes the restrictive requirements previously placed on researchers, but that does not mean researchers can simply now purchase marijuana from state-legal medical suppliers to conduct their research. The law still requires registration with the DEA of any clinical research and purchase of research material from DEA-registered manufacturers. DEA has already increased the number of registered suppliers and further increases would make research easier.
Medical dispensaries should now qualify for business exemptions on their federal taxes, which removes a substantial financial burden on those businesses. But to qualify for such benefits, these businesses will need to register with the federal government, which will bring greater federal oversight of state-legal medical marijuana operations.
While access to banking is not technically resolved by this change - and not resolved at all for recreational marijuana businesses - banks may perceive less risk in making loans to medical marijuana businesses and serving their other banking needs. This change may also help push Congress to enact marijuana banking reform.
Q: There has been renewed interest in psychedelics - like MDMA to treat depression, post-traumatic stress disorder (PTSD) and substance use disorder - and a desire to accelerate research on and approval of psychedelic therapy. What would it take for psychedelics to be approved by the FDA?
Dan Cahoy, Robert G. and Caroline Schwartz Professor of business law and chair of the department of risk management at Penn State's Smeal College of Business, is an expert in intellectual property and business law, including FDA regulatory policy, pharmaceutical patents and government incursions related to increasing access to medicines.
Cahoy: In general, if a treatment involves a cannabis-derived medicine or psychedelic that is used to treat or cure a disease, as opposed to recreational use, it must be approved by the FDA as a drug or biologic, which are medications made from living cells or organisms. FDA approval is only granted after a drug or biologic passes three phases of review that establish safety and efficacy. In other words, an applicant must show that their treatment produces a beneficial outcome in relation to existing treatments that outweighs the risks.
In April 2026, the president issued an executive order directing several federal agencies, including the FDA, to accelerate the review process for psychedelics and even permit non-approved use under the "right to try" system in the hope that new treatments will emerge. However, accelerated reviews do not circumvent the process, though they can rely on early-stage proofs of efficacy. They may also require post-approval review to confirm that the drug is truly effective in the long run.
Not everyone supports accelerated review for treatments using cannabis or psychedelics. Some believe that regulators may end up rushing to approve such treatments before enough evidence of adverse effects is available. And such drugs may not work better than existing treatments, sending patients down the wrong path.
Q: GLP-1 drugs like Ozempic and Wegovy have exploded in popularity. How do GLP-1s work, and are GLP-1s safe? What are their long-term effects?
Travis Masterson, assistant professor of nutritional sciences at Penn State, studies how technology, media and food marketing influences eating behavior and health outcomes. His research also explores food noise, or food cue reactivity, and the role GLP-1 medications
Masterson: GLP-1 medications mimic a signaling molecule that's released when you consume food and helps with digestion and absorption of food. We also see a psychological effect that may be helping with weight loss because there are GLP-1 receptors throughout the body, including the brain.
When you see food, you have a physical response which, combined with internal signals like hormones, leads you to eat. One reason it can be hard to maintain weight loss is because when you lose weight, your body ramps up internal signals to drive your weight back up. We think that GLP-1s may act as a counter signal, balancing hormone levels and reducing "food noise" - the constant mental chatter about food and eating - and tells your body to slow or stop eating and not pay as much attention to food.
There's still a lot we don't know about the long-term effects of GLP-1s. If people choose to stop taking them, we don't know how to set people up for success without the medication or if there's a maintenance dose that still provides benefits. There are also concerns such as the losing too much muscle while taking GLP-1 medications.
Q: What's not being discussed about GLP-1s that you think is important for the public to know?
Masterson: In clinical trials, where we see the most meaningful weight loss results, GLP-1 medications are always given alongside nutritional and physical activity coaching. But in the real world, these medications are being prescribed by physicians and telehealth companies without the additional support that patients might need or could benefit from to support weight loss and health.
The other thing is that we don't expect everyone to have the exact same experience on GLP-1s. Like all medications, some people respond to GLP-1s better than others while others may not experience weight loss.
Q: There's been interest in GLP-1 medications as a potential treatment for substance use disorder. What do we know and don't know about the use of GLP-1s for addiction treatment?
Sarah Kawasaki, associate professor of psychiatry and behavioral health and of medicine at Penn State College of Medicine, is an addiction medicine specialist who studies opioid use disorders. She is currently part of a team that's investigating the use of GLP-1 medications to reduce cravings among people with opioid use disorder through a clinical trial.
Kawasaki: There have been anecdotal reports that in addition to helping with weight loss, people taking GLP-1s have noticed less "noise" or constant thoughts about food and even alcohol or other substances.
There are some very promising results on GLP-1s and alcohol use disorder such as reduced cravings and use of alcohol. But so far, those results have only been seen in individuals who are overweight or have obesity.
Similarly, there's very little data on the use of GLP-1 medication for opioid use disorder. We don't know the ability of GLP-1s to aid existing treatments for opioid use disorder, like methadone and buprenorphine, until the study results are in. There are studies, including a clinical trial that Penn State is leading to see if GLP-1s can help reduce opioid cravings, but we need more research.
Q: While the number of deaths attributed to opioid overdose has declined in recent years, opioid use disorder still claims many lives every year. What are the major barriers to opioid use disorder treatment?
Kawasaki: The most effective treatment for opioid use disorder is behavioral counseling coupled with FDA-approved medications called medication for opioid use disorder, or MOUDs. However, there are only three FDA-approved MOUDs: methadone, buprenorphine and naltrexone.
While regulations on methadone have relaxed considerably over the last two years, which makes treatment more accessible, methadone can only be prescribed through federal- and state-licensed clinics for the treatment of opioid use disorder. There are approximately 2,100 clinics in the United States, but clinics aren't evenly distributed, leaving some areas, like rural communities, underserved. Potential cuts to insurance coverage, such as Medicaid, could also make it harder for people to access clinics and afford treatment.
Another factor is that the powerful synthetic opioid fentanyl has replaced heroin as the predominant illicit opioid used, and it's changed how doctors treat opioid use disorder. Because of fentanyl's unique chemistry, it has become harder for physicians to start individuals on buprenorphine treatment. That, in turn, has increased the need for and access to methadone.
There are proposals that would expand access to treatment. For example, there's currently a bill in Congress that would allow for outpatient addiction medication physicians to prescribe methadone.
