Political Quotes

“I will include an exchange of letters between the Committee on Energy and Commerce and the Committee on the Judiciary. Mr. Speaker, H.R. 639 seeks to improve the transparency and consistency of the Drug Enforcement Administration's first scheduling of new FDA-approved drugs under the Controlled Substances Act, the CSA, and, secondly, its registration process for the manufacture of controlled substances for use in clinical trials. Ultimately, this will allow new and innovative treatments to get to patients who desperately need them. Due to the cost and uncertainty of the drug development process, there is broad agreement that a predictable timeline for approval decisions is a necessary component to successful drug development. Industry, the FDA, and Congress have taken steps to provide more transparency and consistency in the drug approval process through the negotiation and authorization of the Prescription Drug User Fee program and a commitment to review goals embedded in the PDUFA agreements. However, drugs that contain substances that have not been previously marketed in the U.S. and that have abuse potential must also be scheduled under the Controlled Substances Act, the CSA, by the DEA before they can reach patients. Under the CSA, there is no deadline for the DEA to make a scheduling decision, and the delays in DEA decisions have increased significantly.…”