Honorable Dan Patrick, Lieutenant Governor, Senate Honorable Dennis Bonnen, Speaker of the House, House of Representatives
FROM:
John McGeady, Assistant Director Sarah Keyton, Assistant Director Legislative Budget Board
IN RE:
HB3148 by Parker (Relating to the administration and oversight of investigational adult stem cell treatments administered to certain patients.), Conference Committee Report
No significant fiscal implication to the State is anticipated.
The bill would require that institutional review boards that oversee investigational stem cell treatments either be affiliated with a medical school, affiliated with a hospital, accredited by the Association for the Accreditation of Human Research Protection programs, registered by the United States Department of Health and Human Services, or accredited by another national accreditation organization acceptable to the Texas Medical Board (TMB).
The bill would require the Department of State Health Services (DSHS) to establish and maintain an investigational stem cell registry. Under the provisions of the bill, DSHS may not establish an investigational stem cell registry until September 1, 2027.
The bill would prohibit a government entity from considering an adult stem cell product to be an adulterated or misbranded drug solely on the basis of the drug not being approved by United States Food and Drug Administration.
DSHS and TMB indicate that the provisions of the bill could be absorbed using existing resources.
Local Government Impact
No significant fiscal implication to units of local government is anticipated.
Source Agencies:
537 State Health Services, Department of, 503 Texas Medical Board, 529 Health and Human Services Commission