FDA Votes Against Approving MDMA
The Food and Drug Administration (FDA) must approve every ingredient before it can be used as an ingredient in a food or pharmaceutical drug. It is the regulatory body that decides, among other things, which food dyes are legally considered edible, thereby determining which radiant hues can be present in the candies in your Trick or Treat pumpkin. If you are wondering why it is so hard to find fresh mangosteen fruit or black currant flavored candies in the United States, thank the FDA. This month, you can also thank the FDA for putting a damper on your ecstasy. The FDA voted not to approve an application that would allow the legal use of the psychedelic chemical MDMA in pharmaceutical drugs. This is a setback, albeit probably a temporary one, in the long quest to make psychedelics a widely available treatment for mental illnesses such as post-traumatic stress disorder (PTSD). Thus, as of July 2024, MDMA remains a Schedule I controlled substance. If you are facing criminal charges for possession of MDMA, contact a Florida drug offenses attorney.
What Went Wrong With the MDMA Application for FDA Approval?
Popular support for psychedelics as part of the treatment regimen for mental illnesses ranging from depression and PTSD to substance use disorder has been growing over the past few years, especially as the public has embraced cannabis as a medicine rather than a recreational drug. Clinical trials on MDMA and other psychedelics have offered hope to patients who have tried just about everything else without finding long-term relief for their symptoms.
One of these clinical trials was the cornerstone of the recently rejected application for FDA approval for MDMA. The FDA rejected it because the study had so many flaws that it could not prove that the study patients benefited from MDMA in the ways that the authors of the study claim that they did. For example, the FDA alleged that the authors reported the positive results while failing to report the negative ones. They also claimed that clinical staff coached patients to give more positive responses to questionnaires about the improvement of their symptoms after taking MDMA.
Flawed research methodology is common in clinical trials and other published studies. If you want to know how widespread it is, just visit the Retraction Watch website. In fact, many medical studies that make news headlines are based on studies that are imperfectly designed or imperfectly conducted. A flawless research study would require a team of researchers with superhuman abilities; therefore, the discussion sections of published studies address the limitations of the present study and how future studies could fill in information that the present study was unable to discover.
Contact FL Drug Defense Group About Drug Cases
A Central Florida criminal defense lawyer can help you if you are facing charges for illegal drugs because the MDMA that you use to maintain your state of mental wellness isn’t legal yet. Contact FL Drug Defense Group in Orlando, Florida to discuss your case.
Source:
clickorlando.com/health/2024/07/26/veterans-lobbied-for-psychedelic-therapy-but-it-may-not-be-enough-to-save-mdma-drug-application/
