November 18, 2015

House Passes Reform for Regulations Covering New Medical Therapies, Bill Heads to President’s Desk

Washington, D.C. – A new 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 has passed in Congress and is now on its way to the President’s desk.  Senator Sheldon Whitehouse, D-R.I., a member of the Senate Health, Education, Labor, and Pensions (HELP) committee, and Sen. Orrin Hatch, R-Utah, a member and former chairman of the Senate HELP Committee, lauded House passage of the Improving Regulatory Transparency for New Medical Therapies Act, for which they are the original cosponsors.

“A slow and seemingly unnecessary DEA approval process is preventing patients from getting new and innovative treatments that can help them,” said Whitehouse. “This legislation will limit the amount of time the DEA has to make a decision, ensuring quicker access for patients.  I thank Senator Hatch for working with me on this bill and our House counterparts for moving it forward.  I look forward to having it signed into law by the President.”

“I am pleased the House of Representatives has passed this important legislation to give patients faster access to newly approved therapies,” Hatch said. “Our regulatory approach shouldn’t ignore the urgent needs of America’s patients for lifesaving treatments. Enacting this law is an important step in streamlining administrative processes, increasing transparency, promoting medical innovation, and improving patient health.”

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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