TSCR Comments to DSHS Pursuant to Senate Bill 7
Texans for Stem Cell Research (TSCR) Public Comments to DSHS Pursuant to Senate Bill 7 Article 14, 82nd Legislative Session
Texans for Stem Cell Research (TSCR) welcomes the opportunity to comment on the proposed rules for an adult autologous stem cell bank in Texas. TSCR believes that patient safety is paramount when considering any rules or regulations that have the potential to affect the health of our fellow Texans considering banking their stem cells. We applaud DSHS for drafting these rules and making patient safety a priority.
TSCR believes these rules are a great first step as Texas moves forward to being a worldwide leader in stem cell research and ultimately therapies. In order for these rules to be most effective, DSHS should consider designating a qualified medical professional or scientist, knowledgeable in stem cell research banking and storage, with the authority to enter and inspect these facilities at any time to ensure compliance. TSCR believes this oversight is important to ensure transparency in operations and product quality.
TSCR appreciates the fact that any company in this business registered with the state needs to adhere to all federal laws and remain in compliance with the Food and Drug Administration (FDA). However, the FDA is a heavily burdened agency with many responsibilities and we believe it will be difficult for them to monitor new banks properly. In addition, TSCR believes DSHS should have the authority to enforce these rules. TSCR strongly believes the need for this oversight justifies this FTE. If DSHS needs funding for the position, DSHS should request the necessary funding for enforcement and product quality inspections in the next legislative session.
Thank you again for your leadership on this issue and for allowing TSCR to make public comments on the record. TSCR and the citizens of Texas appreciate the work you do.