08. CDC, FDA, NIH Reform

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8 CDC, FDA, NIH Reform
8.1. [AGENCIES] This section includes the following federal agencies: CDC, FDA, NIH.
8.2. [PROHIBIT] No Federal agency shall prohibit any private medical doctor or person from the use of any products, procedures, or services during a medical emergency, patient critical condition, or the possibility of a condition deteriorating into a critical condition as determined by an attending medical doctor.
8.3. FDA
8.3.1. [ACCOMPLISHED] Clinical trials must be fully accomplished before an FDA approval is granted.
8.3.2. [APPROVAL] An approval may only be granted to a product that is at least possibly safe.
8.3.3. [DISTINCT] A product which is only legally distinct may not have a simultaneous EUA and Approval. A product which is atomically distinct requires a separate approval process sharing no funding, data, results, or approval/EUA elements.
8.3.4. [FOIA] The FDA has no authority to withhold any documents, data, research, records, computer data, or knowledge from FOIA requests. Personally Identifiable Information (PII) and Protected Health Information (PHI) must be redacted.
8.3.5. Reporting of Clinical Trials Deficiencies [TRIALHOTLINE] Clinical Trials Hotline. The FDA shall create and adequately staff a “Clinical Trials Hotline” permitting 24/7/365 telephonic, email, or website report submission from any person involved in clinical trials who believes an improper activity has occurred. Complaints may only be made by an individual person(s) and not a government agency or corporation. The FDA shall create and maintain a Clinical Trials Hotline website which allows secure uploading of large quantities of electronic data (files, videos, recordings, documents, etc.) related to a hotline report by the complainant or other involved persons. The FDA shall retain any uploaded documents indefinitely. All information submitted to this office shall be kept as a record. The record retention requirement of this information shall be indefinite. It is a felony to alter, delete, or lose any record. The agency director, followed in succession by the next in the organizational hierarchy, shall be accountable for the integrity and preservation of records. Any submitted record shall be kept confidential, immune from disclosure or disclosure via FOIA until either: (a) the FDA makes any preliminary finding corroborating any statements in the report, (b) a period of 1 year has elapsed from the initial report. PII and PHI will be redacted. The clinical trials hotline website shall maintain a publicly accessible database of all clinical trial hotline reports with PII and PHI redacted.
8.3.6. [TRIALBOARD] Clinical Trials Hotline Investigatory Board The FDA shall staff an investigatory board capable of on-site observation within 48 hrs of a Hotline report. Members of the investigatory board shall have scientific credentials and may not currently be serving as FDA management. Members of the board may not have past, present, or future employment with the corporation that is a target of the investigation. A board shall consist of at least 3 members. Sufficient personnel shall be trained such that 3 boards may be deployed at any time. If an insufficient number of boards exist to investigate a report, the investigatory target shall suspend the operation being complained about to the hotline. It is a felony for any FDA employee, manager, supervisor, or administrator to influence the actions or statements of a member of the investigatory board. It is a felony for any member of the board to fail to investigate, document, and report publicly any aspect of the investigation. The FDA shall provide security and housing to any hotline complainant if requested by the complainant. The FDA shall inform any complainant that they are entitled to protection and housing. Protection and housing shall be extended to family members of the complainant. The manufacturer shall reimburse the FDA for any costs related to protection or housing within 30 days of being issued a bill. At a minimum, the board shall: Collect statements from all trial participants after having shown the participants every part of the original hotline complaint. Collect and/or preserve all research materials, physical or electronic, related to the trial. Collect any evidence. Inform any employee involved in the trial (including former involvement in the trial) that the FDA is a conducting an investigation and that they may submit any evidence or statements they feel should be known by the FDA investigatory board. The board shall investigate the specifically referenced physical sites being alleged to having committed violations as referenced in the initial hotline report. The FDA may only terminate the investigation only after the employee making the original report signs a statement affirming that the FDA has adequately investigated and publicly disclosed any factual findings. If the board provides no public reports of factual findings within 15 days of the initial report, and every 15 days thereafter, then the trial shall be immediately halted. The manufacturer may not restart the trial or re-use any data or participants from the original trial. The manufacturer may not terminate or re-assign the duties of any employee involved in the clinical trial unless the trial is permanently canceled and no similar trial is initiated within 5 years. If the complainant alleges any member of the board is not acting in good faith, that board member shall be replaced by another board member. All aspects of any reporting made about a trial shall be made available as informed consent for any applicable medical treatment, procedure, or product. If any element of the investigation corroborates any aspect of the hotline complaint, a criminal referral shall be made to the DOJ and the State Attorney General at the conclusion of the board’s investigatory activities. A contractee shall be fully culpable for the behavior of a contractor. Lack of oversight is at least willful negligence.
8.3.7. No FDA approval may be given to any treatment, procedure, or product which has an FDA hotline investigation pending or which has a finding of any evidence of improper or illegal behaviors.
8.3.8. The FDA shall immediately inform the person making a hotline report whenever any element of their report has been corroborated either as a preliminary finding or a final finding. The complainant shall be given access to any evidence gathered. The complainant may not release any information observed unless it has been officially released by the Hotline Investigatory Board.
8.4. [CDC] CDC
8.4.1. The CDC has no authority to withhold any documents, data, research, records, computer data, or knowledge from FOIA requests. PII and PHI must be redacted.
8.5. [NIH] NIH
8.5.1. NIH is prohibited from funding projects it cannot audit yearly for violations of contract.
8.5.2. NIH may not fund any research outside the continental United States.
8.5.3. The NIH is prohibited from funding “gain of function” research or any other research which has the possibility of generating or contributing to a pandemic or mass public health event.
8.5.4. The NIH may not fund any corporation, person, or group of persons affiliated in any way with a country having a history of human rights abuses.
8.6. [OVERSIGHT] Oversight Board
8.6.1. Any member of Congress will establish an oversight board over any federal agency in this section within 7 calendar days if any US citizen expresses a belief, and sends a written request to a Congressman, that the FDA is engaged in any improper activity. Each Congressman may commission a maximum of one oversight board per year with the ability of continuing the commission of a previous board. The board will have full investigatory power to observe, subpoena, research, interview, or pause any agency functions until the board’s work is complete. All boards shall make available any evidence gathered to any other board on the same day evidence is gathered. All findings shall be simultaneously made available to the general public via website within 24 hrs of collection. Only Protected Health Information (PHI) shall be redacted from materials. Electronic record keeping shall be used to make this possible. Funding. The board shall be funded by the existing agency budget at the direction of the organizing Congressman. Funding shall be sufficient to provide basic office supplies, computer equipment, per diem, and hotel housing, transportation (rental vehicles) at least equal to those afforded to a government employee of that agency, during the full period of the board’s commission. Members of the board. The citizen making the complaint shall have the ability to choose any three people to serve as board executives with full administrative authority over any other members appointed by the Congressman. Conflicts of interest. No member may be placed on the board if that individual has employment with any corporation overseen or doing business with the respective federal agency. The individual may not be an employee of a federal agency.


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