The recent election of Donald Trump as President has introduced significant shifts in the U.S. healthcare landscape. Notably, President Trump has announced his intention to appoint Robert F. Kennedy Jr. to oversee federal health agencies, including the Department of Health and Human Services (HHS), the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), the National Institutes of Health (NIH), and the Department of Agriculture (USDA).
In alignment with his new role, RFK Jr. has launched Policies for the People, an open-sourced policy forum designed to bridge the gap between Washington policymakers and the public. This platform empowers Americans to propose and discuss policies that directly impact their lives, fostering a collaborative approach to governance.
One pressing issue within the GLP-1 community, and the broader healthcare sector is the recurring shortage of GLP-1 medications, which are vital for treating obesity and type 2 diabetes. These shortages have disrupted treatment plans and compromised patient health. To address this, On The Pen is advocating for policy change on the Policies for the People forum, aiming to enhance transparency in drug shortage reporting and protect the rights of 503B compounding pharmacies to produce GLP-1 medications during shortages.
Key Components of the Proposed Policy:
Mandatory Public Transparency in Drug Shortage Reporting:
Detailed Reporting Requirements: Pharmaceutical companies experiencing or anticipating shortages in FDA-approved GLP-1 medications must submit comprehensive public reports to the FDA, detailing the causes, expected duration, mitigation efforts, and timelines for restoring supply.
Public Access to Shortage Data: All data provided to the FDA regarding shortages—including manufacturing details, inventory levels, and production schedules—should be publicly accessible, enabling patients, healthcare providers, and policymakers to make informed decisions.
Periodic Public Updates: These reports should be updated every 30 days and made accessible to inform stakeholders of the current status and anticipated availability of medications.
Requirement for Six-Month Buffer Stock:
Buffer Stock Based on Demand Projections: Pharmaceutical companies must maintain at least six months of buffer stock for GLP-1 medications, calculated based on the most recent demand projections, including sales forecasts provided to investors.
Verification and Accountability: The FDA should have the authority to verify the accuracy of buffer stock reports and monitor compliance, with penalties for non-compliance and provisions to increase buffer stock requirements for repeat offenders.
Annual Disclosure of Buffer Stock Data: Companies must publicly disclose buffer stock levels annually, allowing for independent review of whether adequate safeguards are in place to meet potential demand surges.
Empowering 503B Pharmacies to Compound GLP-1 Medications During Shortages:
Protections for Compounding During Shortages: In the event of an FDA-declared shortage of GLP-1 medications, 503B compounding pharmacies should be permitted to produce compounded versions to bridge supply gaps, with automatic permission if a shortage persists beyond 30 days.
Streamlined Oversight for Rapid Response: FDA oversight should ensure safety and quality standards while streamlining regulatory processes during shortages to expedite patient access without unnecessary delays.
Exemption from Duplication Restrictions: 503B pharmacies should be allowed to temporarily produce compounded GLP-1 medications that replicate FDA-approved formulations when commercial supply is insufficient to meet demand.
Annual Review and Congressional Oversight:
Annual Reporting to Congress: The FDA should submit an annual report to Congress on the status of GLP-1 shortages, adherence of pharmaceutical companies to reporting and buffer stock requirements, and the role of 503B pharmacies in supplementing access during shortages.
Review of Policy Effectiveness: A yearly review committee should assess the policy’s effectiveness, evaluating patient access, pharmaceutical compliance, and the impact on compounding pharmacies, with adjustments considered based on real-world outcomes.
This policy aims to safeguard patient access to critical medications by mandating transparency, ensuring sufficient buffer stock levels, and protecting 503B pharmacies’ ability to fill demand during shortages. Requiring pharmaceutical companies to disclose detailed shortage data and maintain robust buffer stocks will create a more accountable and patient-focused healthcare system, ensuring reliable access to essential GLP-1 treatments even in times of supply chain instability.
Call to Action:
To support this initiative and ensure it garners the attention it deserves, please visit the Policies for the People forum and "like" the proposal. Your engagement is crucial in advocating for policies that prioritize patient health and transparency in the pharmaceutical industry.
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