October 27, 2015

Senate Passes Improving Regulatory Transparency for New Medical Therapies Act

Washington, DC – The Senate has passed a bipartisan measure that would bring predictable timeframes to the Drug Enforcement Agency (DEA) scheduling process so new treatments can reach patients in a timely and transparent manner. Senators Sheldon Whitehouse (D-RI) and Orrin Hatch (R-UT), who sponsored the legislation, lauded Senate passage of the Improving Regulatory Transparency for New Medical Therapies Act.

“Right now, patients too often have to wait for promising new treatments because of a slow and seemingly unnecessary DEA approval process,” said Whitehouse.  “This legislation will limit the amount of time DEA has to make a decision, ensuring quicker access for patients.  I thank Senator Hatch for working with me on this bill, and I’m glad we were able to pass it today.”

“Our regulatory approach shouldn’t ignore the urgent needs of America’s patients for lifesaving treatments,” said Hatch. “This bill would bring much-needed certainty to the scheduling process and give patients quicker access to new therapies by setting timelines by which the DEA must schedule new drugs. This legislation will improve both patient health and medical innovation, and I look forward to getting this legislation through the final steps and to the President’s desk.”

The Improving Regulatory Transparency for New Medical Therapies Act will now return to the House of Representatives, where the Senate version will be voted on before the bill heads to the President’s desk.

The Improving Regulatory Transparency for New Medical Therapies Act will amend the Controlled Substances Act to require the DEA to schedule a drug or substance that has never been marketed in the United States within 90 days of receiving a scheduling recommendation from the Secretary of the Department of Health and Human Services. In addition, the legislation clarifies that for this subset of drugs that must be scheduled, market exclusivity periods begin on the date a product can actually be marketed, just as it is for other new drug products.

The bill will also allow a company applying to register with the DEA to manufacture a controlled substance to indicate on the application that the substance will only be used for clinical trials of a drug. DEA would be required to either make a final decision on the application for registration within 180 days or inform the applicant of the outstanding issues that must be resolved to reach a final decision.


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