I have been working very hard with Senator Harkin, members of the HELP Committee, and members of the House Energy and Commerce Committee on legislation to provide options for patients and providers who want compounded drugs made in FDA-regulated facilities. As we debate this bill today, I want to make clear that all involved on this legislation have no intent of limiting patient or provider access to quality compounded drugs that fill a clinical need. The process in the HELP Committee began as soon as news of the outbreak broke in Tennessee, and I cannot thank enough the folks at the Tennessee Department of Health, including Dr. Kainer, for all their good work that prevented so many further cases and lives being destroyed. We have been working very hard to reach an agreement on how compounding should be regulated--and we have come a long way. Stakeholders including pharmacists, public health groups, and the FDA, have been sitting around a table to find a consensus solution. We have made good progress, and I want to talk about this legislation. For traditional pharmacy, currently regulated under 503A of the Food, Drug, and Cosmetic Act, we strike the provisions found unconstitutional by the Supreme Court related to marketing.…
Share
More from Heidi Alexander
here is my view of serving in the U.S. Senate: It is hard to get here, it is hard to stay here, and while you are here, you might as well try to accomplish something good for the country. Accomplishing something good in the U.S. Senate…
I ask unanimous consent that I be recognized to speak for as long as I may require. The PRESIDING OFFICER. Without objection, it is so ordered. ____________________
our great country has developed a dangerous habit when it comes to pandemics. Public health experts call it panic, neglect, panic. In 2007, after the emergence of the Asian flu, former Utah Governor Mike Leavitt, who was then the Secretary…
I thank the Senator from Ohio for his courtesy, as well as his leadership. I will not be long. (The remarks of Mr. Alexander pertaining to the introduction of S. 4284 are printed in today's Record under ``Statements on Introduced Bills and…





