“This isn't idealism. This is pragmatic innovation.” https://medium.com/@QNFO/choose-innovation-choose-autonomy-cea14683001f
Subject: Urgent Call for Fundamental Reform: Addressing Regulatory Capture and Prioritizing Public Health
Dear FDA Commissioner,
I am writing to you today as Rowan Quni, Executive Director of Empowering Change, a harm reduction nonprofit dedicated to supporting individuals and communities affected by substance use and addiction. I also write as a former drug addict myself, someone who has firsthand experience with the devastating consequences of addiction and the failures of our current drug policies.
From the front lines of this public health crisis, we witness daily the tragic consequences of regulatory failures and the undue influence of the pharmaceutical industry. The approval of the fentanyl patch, with its tragic consequences, serves as a stark reminder of how the pursuit of profit can override the paramount duty to protect public health.
The fentanyl crisis is a direct result of the pharmaceutical industry's relentless push for more potent and longer-acting opioids, often under the guise of "improved pain management." The focus on profit-driven innovation, rather than patient safety, has led to a flood of highly addictive and dangerous opioids into our communities.
As a former drug addict, I understand the insidious nature of addiction and the desperate measures people take to alleviate suffering. The availability of highly potent and easily accessible opioids like fentanyl has fueled this crisis, leading to countless overdose deaths and devastating families across the nation.
The FDA, as the guardian of public health, must break free from the stranglehold of industry influence. The current system, with its opaque decision-making processes, undue deference to industry interests, and limited transparency, fosters an environment where patient safety can be compromised.
This regulatory capture manifests in various ways:
* The "evergreening" of patents: Pharmaceutical companies exploit loopholes to extend their market exclusivity, delaying the availability of more affordable generic medications and denying patients access to life-saving treatments.
* The prioritization of profit over innovation: The FDA often prioritizes the approval of incremental improvements to existing drugs, rather than fostering true innovation in areas of unmet medical need. This focus on incremental gains serves the interests of pharmaceutical companies seeking to maintain their market dominance.
* The erosion of public trust: The perception of industry influence within the FDA erodes public trust in the regulatory system. This distrust can have serious consequences, leading to vaccine hesitancy, non-compliance with medical advice, and a general sense of cynicism about the healthcare system.
To address this critical issue and restore public trust, I urge the FDA to take the following bold steps:
* Establish an Independent Scientific Advisory Board: Create a truly independent board, free from industry influence, to provide scientific and ethical oversight of all drug approval decisions. This board should include representation from public health experts, patient advocacy groups, and independent researchers.
* Implement a "Sunshine Act" for the FDA: Mandate the public disclosure of all meetings and communications between FDA officials and representatives of pharmaceutical companies. This transparency will help to ensure that industry influence does not unduly sway regulatory decisions.
* Prioritize public health research: Increase funding for independent research on drug safety, efficacy, and long-term outcomes. This research should inform regulatory decisions and help to identify potential risks and benefits of new medications.
* Promote non-pharmacological interventions: Actively support and promote non-pharmacological approaches to healthcare, such as lifestyle modifications, preventative measures, and complementary therapies. This will help to ensure that patients have access to a full range of treatment options.
The FDA has a unique and crucial role to play in safeguarding public health. By addressing the issue of regulatory capture and prioritizing the needs of patients above the interests of the pharmaceutical industry, the agency can regain the public's trust and fulfill its vital mission.
Sincerely,
Rowan Quni
Executive Director, Empowering Change
Former Drug Addict
I just upended the entire intellectual property system for the better. Read all about it! https://qnfo.org/notes/0.5/2025-01-04/20250104-145803
Despite our growing ability to manipulate the physical world, including even the fabric of spacetime in ways previously unimaginable, the unidirectional flow of time remains stubbornly beyond our control. While we can measure time with exquisite precision and account for its relativistic effects, we cannot reverse it, accelerate it, or isolate it from the unfolding of events. This inherent uncontrollability of time presents a fundamental limit to our understanding of the universe. The persistent linearity of cause and effect, bound by time's arrow, serves as a stark reminder of this ultimate constraint.