HB1332: HB1332 Georgia Buy American Medicine Act; enact

26 LC 46 1498S The House Committee on Health offers the following substitute to HB 1332: A BILL TO BE ENTITLED AN ACT To amend Chapter 2 of Title 31 of the Official Code of Georgia Annotated, relating to the1 Department of Community Health, so as to require certain hospitals to give a preference to2 American manufactured pharmaceuticals; to provide for definitio ns; to provide for3 exceptions and waivers; to provide for documentation; to provide for rules and regulations;4 to provide for construction; to provide for related matters; to provide for an effective date;5 to provide for a short title; to provide for legislative findings; to repeal conflicting laws; and6 for other purposes.7 BE IT ENACTED BY THE GENERAL ASSEMBLY OF GEORGIA:8 SECTION 1.9 This Act shall be known and may be cited as the "Georgia Buy American Medicine Act."10 SECTION 2.11 The General Assembly finds that:12 (1) Responsible stewardship of state taxpayer funds and the promotion of public health13 security are important priorities for this legislative body;14 H. B. 1332 (SUB) - 1 - 26 LC 46 1498S (2) American-made prescription drugs are generally safer for c onsumption than15 foreign-made prescription drugs;16 (3) Domestic drug production facilities undergo more frequent inspections by the federal17 Food and Drug Administration than do international facilities, providing higher certainty18 regarding manufacturing standards;19 (4) Domestic drug production facilities are much more likely t o be inspected without20 receiving advance notice than are international facilities, fur ther ensuring the safety of21 American-made prescription drugs;22 (5) The federal Food and Drug Administration has found higher rates of drug quality23 deficiencies in foreign-made than in American-made prescription drugs;24 (6) When hospitals give American-made prescription drugs preference over similar drugs25 from other countries, doing so encourages the standardization o f uniform drug26 concentrations, thereby further protecting consumers; 27 (7) Domestic sourcing of prescription drugs reduces reliance o n foreign countries for28 essential medicines that may experience shortages; and29 (8) Many hospitals in this state receive taxpayer funds yet do not give American-made30 prescription drugs any preference over foreign-made drugs.31 SECTION 3.32 Chapter 2 of Title 31 of the Official Code of Georgia Annotated, relating to the Department33 of Community Health, is amended by adding a new Code section to read as follows:34 "31-2-20.35 (a) As used in this Code section, the term:36 (1) 'American manufactured pharmaceutical' means a prescriptio n drug or medication37 that is manufactured, processed, and finished at a facility located within the United States38 and registered with the federal Food and Drug Administration.39 H. B. 1332 (SUB) - 2 - 26 LC 46 1498S (2) 'Finished' means a drug product in the form in which it wi ll be administered to a40 patient, such as a tablet, capsule, solution, or topical application.41 (3) 'Healthcare provider' means any hospital, health system, c linic, or medical facility42 licensed to operate in the State of Georgia that receives state funds.43 (4) 'Reasonably available' means available in sufficient quantity, quality, and timeliness44 to meet patient care needs without causing unreasonable delay or disruption.45 (5) 'State funds' means any funds appropriated or distributed by the State of Georgia or46 any of its agencies, departments, authorities, or political subdivisions, excluding federal47 funds.48 (6) 'Substantially higher' means greater than 20 percent.49 (b) Any healthcare provider receiving state funds shall give p reference to American50 manufactured pharmaceuticals when procuring prescription drugs for use in patient care,51 provided such pharmaceuticals are reasonably available.52 (c) The preference referenced in subsection (b) of this Code section shall apply only to the53 expenditure of state funds and sh all not apply to federal funds or any funds subject to54 federal procurement requirements.55 (d) A healthcare provider may procure pharmaceuticals not manu factured in the United56 States if:57 (1) An American manufactured pharmaceutical is not reasonably available;58 (2) Procurement of an American manufactured pharmaceutical would jeopardize patient59 safety or clinical outcomes;60 (3) The pharmaceutical is required in response to a public hea lth emergency, drug61 shortage, or disaster; or62 (4) The cost of the American manufactured pharmaceutical is su bstantially higher or63 would significantly limit patient access or care.64 (e) Healthcare providers shall document the basis for any exception under subsection (d)65 of this Code section and retain such documentation for a minimum of three years.66 H. B. 1332 (SUB) - 3 - 26 LC 46 1498S (f) The department shall promulgate rules and regulations necessary to enforce this Code67 section.68 (g) Failure to comply with this Code section may result in corrective action plans or, for69 repeated or willful violations, suspension or termination of eligibility to receive state funds.70 (h) Nothing in this Code section shall be construed to interfe re with a physician's71 independent medical judgment or patient-specific treatment decisions.72 (i) Nothing in this Code section shall be construed to conflic t with federal law, federal73 funding requirements, or regulations of the federal Food and Drug Administration."74 SECTION 4.75 This Act shall become effective upon its approval by the Governor or upon its becoming law76 without such approval.77 SECTION 5.78 All laws and parts of laws in conflict with this Act are repealed.79 H. B. 1332 (SUB) - 4 -