Frank Pallone: “Thank you, Mr. Waxman. Mr. Speaker, I rise in support of the Drug Quality and Security Act. This bill represents a…”

“Thank you, Mr. Waxman. Mr. Speaker, I rise in support of the Drug Quality and Security Act. This bill represents a bipartisan, bicameral effort to clarify current pharmaceutical compounding laws and secure our Nation's pharmaceutical drug supply chain. It's the culmination of several months of hard work and tireless negotiations between our committee and the Senate Health Committee. As a result of the terrible tragedy in Massachusetts, the House Energy and Commerce Committee held hearings and engaged with stakeholders and the FDA in order to understand the existing problems and the best options for addressing them. What became clear was a need for patients and providers to have access to safe compounded drugs. This legislation helps ensure that quality compounded drugs are available to patients who need them. This effort also makes clear that FDA's authorities over compounding pharmacies needed to be fixed. A court split decision over the statute had hampered FDA's ability to effectively enforce their authority over compounding pharmacies and ensure the safety and effectiveness of compounded medications. The bill before us will fix this constitutional flaw by deleting the provisions that were deemed unconstitutional by the courts.…”