{"database": "press", "table": "releases", "rows": [["https://www.scott.senate.gov/media-center/press-releases/senator-scott-questions-fda-nominee-on-the-future-of-mrna-and-crispr-technologies/", "Senator Scott Questions FDA Nominee on the Future of mRNA and CRISPR Technologies", "2021-12-14", "2021", "2021-12", "Republican", "Senate", "SC", "Tim Scott", "S001184", "www.scott.senate.gov", "timscott", "https://www.scott.senate.gov/media-center/press-releases/jsf/jet-engine:press-list", "scraper", "WASHINGTON \u2013 Today, U.S. Senator Tim Scott (R-S.C.) questioned Dr. Robert Califf, President Biden\u2019s nominee for Food and Drug Administration (FDA) Commissioner, on the future of mRNA and CRISPR technologies and their potential to treat and cure rare diseases like Sickle Cell Anemia.\n\nClick to watch the senator\u2019s questions\n\nA full transcript is below.\n\nSenator Scott: Thank you, Dr. Califf, for spending some time with us today and talking about some really important issues that we could all spend a day talking about. I only have five minutes, [which is] good news for you.\n\nMy first question is: You\u2019re coming into a very important position in the midst of, really, headwinds in the public health space. And I appreciate the enormity of your responsibilities if you are confirmed to lead the FDA. How do you view the FDA\u2019s role in granting Emergency Use Authorization (EUA) for the new, as well as repurposed, products to address the COVID-19 pandemic? Should the FDA use a wider latitude to ensure multiple avenues\u2014for instance drugs like budesonide, as well as COVID-19 testing kids\u2014making sure that they\u2019re available to combat the pandemic?\n\nDr. Califf: Thanks senator, it\u2019s good to be here with a fellow South Carolinian. \u2026 You\u2019re well aware, and it was during my tenure that the EUA guidance was written that the potential benefits need to be weighed against the potential risks. That\u2019s the authority the FDA is given.\n\nSo there\u2019s a lot of latitude on the types of things that you mentioned, yet I would still point out we need to have enough evidence that we can make a fair assessment of what the potential is, and we need a system in this country, as I\u2019ve emphasized over and over, that produces the evidence more quickly because under that framework, it\u2019s possible you could get it wrong. It\u2019s different if you\u2019ve actually measured the benefits and risks and then you\u2019re confident about it. And so it\u2019s finding that right balance that\u2019s really in play for the FDA.\n\nSenator Scott: No doubt. I would suggest that, based on the severity of the challenge in the public space, that taking the appropriate calculated risk seems to be necessary nowadays more than it has been in the past, and I think we can do that in a way that involves coming to good decisions consistently.\n\nOn the long view of public health, I am excited about the role that the mRNA played in bringing the vaccine to the forefront and saving millions of lives. What\u2019s the future of that technology for future needs in the vaccine arena, number one?\n\nNumber two, I think about the 7,000 rare blood diseases that have very few therapies, [or] treatments of any sort. And I focus a little bit more on CRISPR technologies for things like Sickle Cell Anemia and that path going forward. Do you see: A) more application for CRISPR in the rare blood disease space? And B) on the future forefront of the mRNAs and vaccines, is that future as bright as it appears it could be with the use of these technologies?\n\nDr. Califf: This is one of the things, senator, where the excitement of being part of this is what keeps me going and coming back. I mean, I\u2019m old enough to remember when the Human Genome Project was just being developed, and now we have the code for the genome, and what you\u2019re describing are the downstream consequences of that with reading the code and producing proteins and other substances that determine whether we\u2019re sick or healthy. And there are a whole array of technologies, you know, specifically for mRNA. I think, as a platform for vaccines, this is something that we\u2019ve only dreamed about, but it\u2019s a reality now. And you know, this took a collaboration of FDA scientists and, of course, academia and the private sector all working towards a common goal over decades.\n\nYou also mentioned CRISPR, and the ability to change the fundamental genome is an amazing possibility but also has significant risks. And so, like everything else, we\u2019ve got to come up with the ideas, try them out, and measure things and see what really works, but almost nothing could be more exciting than curing a rare genetic disease with a gene substitution, perhaps for life. And I think, for people with Sickle Cell Disease, I\u2019ve done a lot of work \u2026 I think this is something that\u2019s really needed, and it ties in. You know, chronic treatment for Sickle Cell Disease is not going so well in this country because many of the patients live off the beaten path of the big high-tech centers, and we\u2019ve got to get treatments that are more effective.\n\nSenator Scott: I think we should at least take a second and thank Dr. Francis Collins for his work on the project that really has produced amazing results for our nation and, frankly, for the world. I know he\u2019s retiring or just retired. His work has been amazing for all of mankind, number one. Number two, I would suggest that, as we look into that future, the ethical issues around the new technologies like CRISPR will continue to pop up around the world. I know that China has had some challenges already with the use of CRISPR, and so what becomes a solution also becomes a problem. That\u2019s called reality, and hopefully we will wrestle with those ethical issues in the public forum sometime in the very near future.\n\n###", 1, "2026-03-30T01:40:41Z", "2026-04-06T20:37:48Z"]], "columns": ["url", "title", "date", "year", "month", "party", "chamber", "state", "member_name", "bioguide_id", "domain", "scraper", "source", "date_source", "text", "has_text", "collected_at", "updated_at"], "primary_keys": ["url"], "primary_key_values": ["https://www.scott.senate.gov/media-center/press-releases/senator-scott-questions-fda-nominee-on-the-future-of-mrna-and-crispr-technologies/"], "units": {}, "query_ms": 1.6257541719824076, "source": "dwillis/congress-press", "source_url": "https://github.com/dwillis/congress-press", "license": "MIT", "license_url": "https://github.com/dwillis/congress-press/blob/main/LICENSE"}