top of page
CORRESPONDENCE
IRB: Waiver of Informed Consent on Human Clinical Investigations
Remitted an actionable request to the FDA and HHS to outlining our organizations questions and concerns regarding the "IRB: Waiver of Informed Consent on Human Clinical Investigations" that was issued in July of 2017.
We requested the FDA to add this regulatory change to the Federal Register in order to collect public commentary (post fact) and revise accordingly.
Informed Consent is a basic human right. Engaging in human clinical trials without the partipants' knowledge or consent is a violation of the Belmont Agreement and an abuse of human rights.
We requested the FDA to add this regulatory change to the Federal Register in order to collect public commentary (post fact) and revise accordingly.
Informed Consent is a basic human right. Engaging in human clinical trials without the partipants' knowledge or consent is a violation of the Belmont Agreement and an abuse of human rights.
Pharmaceutical Supply Chain
Sent request for the creation of a federal committee to review issues related to accessing opioid-based medications due to supply chain or public-health policy changes and to make recommendations to address the gaps and inconsistencies in federal polices that are causing public harms.
Correspondence - White House - Office of Public Engagement
Remitted correspondence to the Office of Public Engagement of the White House regarding our concerns of corporate malfeasance and disinformation campaigns being implemented by public, private-partners involved with national drug control and health policy development.
Letter of Inquiry - Oversight and Accountability Committee
Sent a formal letter of inquiry to the Oversight and Accountability Committee Chairman James Comer regarding the NIH-HEAL Initiative's Hemodialysis Opioid Prescription Effort
Submission of Formal Commentary to the CDC
Submitted formal commentary to the CDC Board of Scientific Counselors for the National Center for Injury Prevention and Control regarding their initial "Observations of the Opioid Workgroup" - 2016 CDC Guideline for Prescribing Opioids.
Appropriations Request
Submitted an appropriations request to the House Subcommittee on Labor, Health & Human Services, and Education requesting allocation of funding for an Oversight Committee with additional funding allocation to perform studies assessing and evaluating the impact recent healthcare changes are having on the public's health and well-being.
Addressing the Tri-Crisis
Sent a copy of Addressing the Tri-Crisis to the Biden/Harris Administration. This document outlines goals and recommendations that we would like to see the administration take within the first 100 days of office.
Letter to CMS
Sent a joint letter to CMS requesting communication with the states to permit 90 day supply of schedule II medications during the COVID19 pandemic.
bottom of page