§ 31-53-52. Impact of Insufficient Funding
If at any time it is determined that there is not sufficient funding to finance the ongoing operations of the GAPCD, the GAPCD shall cease operating and the advisory committee and administrator shall no longer have the duty to carry out the functions required pursuant to this article. If the GAPCD ceases to operate, any […]
§ 31-52-2. Legislative Findings
The General Assembly finds and declares that: The process of approval for investigational drugs, biological products, and devices in the United States protects future patients from premature, ineffective, and unsafe medications and treatments over the long run, but the process often takes many years; Patients who have terminal illnesses do not have the luxury of […]
§ 31-52-3. Definitions
As used in this chapter, the term: “Eligible patient” means a person who meets the requirements of Code Section 31-52-4. “Investigational drug, biological product, or device” means a drug, biological product, or device which has successfully completed Phase I of a federal Food and Drug Administration approved clinical trial but has not yet been approved […]
§ 31-52-4. Eligibility Criteria
In order for a person to be considered an eligible patient to access an investigational drug, biological product, or device pursuant to this chapter, a physician must document in writing that the person: Has a terminal illness; Has, in consultation with the physician, considered all other treatment options currently approved by the federal Food and […]
§ 31-52-5. Written Informed Consent
Written informed consent shall, at a minimum, include the following: A description of the currently approved products and treatments for the terminal illness from which the patient suffers; An attestation that the patient concurs with his or her physician in believing that all currently approved and conventionally recognized treatments are unlikely to prolong the patient’s […]
§ 31-52-6. Manufacturers Permitted to Make Investigational Drugs, Biological Products, or Devices Available
A manufacturer of an investigational drug, biological product, or device may make available and an eligible patient may request access to the manufacturer’s investigational drug, biological product, or device pursuant to this chapter; provided, however, that nothing in this chapter shall be construed to require that a manufacturer make available an investigational drug, biological product, […]
§ 31-52-7. Coverage Under Health Benefit Plan Permitted but Not Required
A health benefit plan or governmental agency may provide coverage for the cost of any investigational drug, biological product, or device pursuant to this chapter; provided, however, that nothing in this chapter shall be construed to require a health benefit plan or governmental agency to provide coverage for the cost of any investigational drug, biological […]
§ 31-52-8. Physician Immunity From Sanction for Recommending, Prescribing, or Treating With Investigational Drugs, Biological Products, or Devices
The Georgia Composite Medical Board shall not revoke, suspend, sanction, fail to renew, or take any other action against a physician’s license solely based on such physician’s recommendation, prescription, or treatment of an eligible patient with an investigational drug, biological product, or device pursuant to this chapter. History. Code 1981, § 31-52-8 , enacted by […]
§ 31-52-9. State Prohibited From Blocking Eligible Patient Access
No official, employee, or agent of the state shall block or attempt to block an eligible patient’s access to an investigational drug, biological product, or device. Counseling, advice, or a recommendation for treatment consistent with medical standards of care shall not be construed as a violation of this Code section. History. Code 1981, § 31-52-9 […]
§ 31-49-1. Legislative Findings
The General Assembly finds and declares that it is estimated that as many as 55,000 Georgia residents suffer from lupus, a life-long autoimmune disease in which the immune system becomes unbalanced, causing inflammation, tissue damage, seizures, strokes, heart attacks, miscarriages, and organ failure. Although anyone can develop lupus, it strikes mostly women of childbearing age; […]