Heidi Alexander: “I have been working very hard with Senator Harkin, members of the HELP Committee, and members of the House Energy and…”

“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.…”