Pharmaceutical Industry Reform Act (PATA-Subsection 07)

Health
,
1

Pharmaceutical Industry Reform Act (PATA-07)

[*Draft Work in Progress]

Executive Summary

The PATA-07 seeks to address the capture of regulatory agencies, kickbacks, the misuse of physician licensure, and state actions that infringe on doctors’ rights to free speech when questioning pharmaceutical practices. It aims for a health system where public interest, transparency, and accountability prevail, supported by an independent regulatory body and protections for medical professionals.

Purpose

To eliminate industry capture across regulatory, licensing, and legal entities, ensuring these systems prioritize public health, protect free speech in medical practice, and enable doctors to advocate for patient care without fear of retribution.

Historical Context

  • Regulatory Capture: Documented instances where regulatory agencies have favored industry profits over public health1.
  • Physician Licensure Misuse: Licensing boards have penalized doctors for advocating treatments outside of industry-favored protocols during the recent health crisis2.
  • State Legal Overreach: Actions like California’s attempt to silence doctors on pharmaceutical practices can be seen as First Amendment violations3.
  • Industry Influence on Policy: The pharmaceutical and insurance industries have shaped healthcare policy, often at the expense of public interest4.

Problems

  • Entrenched Conflicts of Interest: Financial ties between regulatory bodies, medical professionals, and industry compromise healthcare decisions5.
  • Suppression of Medical Voices: Doctors have faced censure for questioning or proposing alternatives to industry-backed treatments, infringing on free speech rights6.
  • Lack of Transparency: Opaque relationships between healthcare, state legal bodies, and industry undermine public trust and oversight7.
  • Industry-Driven Health Policy: Decisions influenced by profit, including the misuse of EUA for therapeutics mislabeled as vaccines8.

Key Components

  • Elimination of Industry-Friendly Structures:

    • CDC Foundation:
      • Option 1 - Reform: Refocus the CDC on public health, free from industry influence.
      • Option 2 - Abolish: Replace with a new, independent regulatory entity.

  • Reform or Establishment of Regulatory Agencies:

    • CDC Reform: Ensure independence from industry.
    • NIOSH Independence: Autonomous research and policy advice.

  • Addressing Kickbacks and Incentives:

    • Ban on Kickbacks: Enhance laws against financial incentives for prescribing.
    • Transparency in Financial Relationships: Mandate full disclosure.

  • New Regulatory Body:

    • Composition: Independent doctors, NGOs, with no industry ties.
    • Role: Oversee pharmaceutical practices, protect medical free speech, and monitor licensing integrity.
    • Linkage with IATA: Coordinate with insurance transparency efforts9.

  • Physician Licensure and Free Speech:

    • Protection Against Retaliation: Safeguard doctors from punitive licensing actions for differing from industry-backed treatments or questioning mandates.
    • Licensing Board Oversight: Ensure licensing decisions are based on medical ethics, not industry alignment.
    • Review of Past Actions: Mechanism to reassess licensure sanctions related to the recent health crisis.

  • Addressing State Legal Overreach:

    • First Amendment Protections: Laws to prevent states like California from restricting doctors’ free speech regarding pharmaceutical practices3.
    • State-Industry Collusion: Mechanisms to investigate and prevent collusion between state legal entities and pharmaceutical companies in silencing dissent.

  • Empowering Medical Advocacy Groups:

    • Support for Alliances: Recognize and support groups like the Great Barrington Declaration10 and the Front Line COVID-19 Critical Care Alliance (FLCCC)11 for their advocacy in medical freedom and patient care.

  • Conflict of Interest Mitigation:

    • Cooling-off Period: 10-year wait for former officials before industry employment12.
    • Strict Employment and Financial Disclosure: Full reporting required.

  • Enhancing Transparency and Accountability:

    • Independent Oversight: Empower watchdogs to monitor industry, state, and licensure interactions.
    • Public Participation: Engage the public in health policy and regulatory oversight.

Key Observations

  • Observation-07.1: Regulatory capture has led to health policies favoring industry profits over public health13.
  • Observation-07.2: The suppression of medical professionals’ voices has had a chilling effect on healthcare innovation and patient advocacy14.
  • Observation-07.3: State legal actions against doctors need scrutiny to ensure they do not infringe on constitutional rights3.

Legal Precedents

  • First Amendment Challenges: Legal fights against state laws restricting medical professionals’ speech3.
  • Global Regulatory Models: Examples where independent bodies have managed industry influence15.

Appendix

Public Input

Your input is vital:

  • How can we better protect doctors’ rights to free speech in healthcare?
  • What should be done to prevent state-industry collusion in medical regulation?
  • Share your thoughts on supporting medical advocacy groups or any additional observations here.

Resources

Footnotes

[1]: Mechanisms of regulatory capture: Testing claims of industry influence in the case of Vioxx - Wiley Online Library

[2]: Licensure Actions Against Doctors

[3]: California’s Law on Doctors’ Speech

[4]: The Cost of Capture: How the pharmaceutical industry has corrupted policymakers and harmed patients - Roosevelt Institute

[5]: Editorial: Fraud and Corruption in Healthcare - National Library of Medicine, Frontiers in Public Health

[6]: Censorship and Suppression of Covid-19 Heterodoxy: Tactics and Counter-Tactics
 - Springer Nature

[7]: Transparency Issues in Government - the House Select Subcommittee on the Coronavirus Pandemic Report - key findings: Rampant fraud, waste, and abuse plagued the COVID-19 pandemic response.

[8]: Misuse of EUA for Therapeutics

[9]: Insurance Accountability and Transparency Act (IATA)

[10]: Great Barrington Declaration

[11]: Front Line COVID-19 Critical Care Alliance (FLCCC)

[12]: Cooling-off Periods

[13]: Examples of Regulatory Capture

[14]: Licensure and Public Health Advocacy

[15]: Global Regulatory Models

2

simple solution, make tort reform on medical malpractice illegal and remove liability shielding protections from the industry.

3

Yes @Sean_Collins

That’s discussed in this companion act

:point_right: Policy to Establish the Separation of the Corporatocracy and the State (Addressing Corporate Personhood)