Senators Hatch, Whitehouse Introduce Legislation to Streamline Drug Development Process and Protect Patient Access to Medications

Senators Hatch, Whitehouse Introduce Legislation to Streamline Drug Development Process and Protect Patient Access to Medications

U.S. Senators Orrin Hatch (R-Utah), a current member and former Chairman of the Health, Education, Labor, and Pensions (HELP) Committee, and Sheldon Whitehouse (D-R.I.), a current member of the HELP Committee, introduced two bills inded to streamline the drug development process and protect patient access to needed medications. The bills are titled the “Improving Regulatory Transparency for New Medical Therapies Act” and the “Ensuring Patient Access and Effective Drug Enforcement Act of 2015."

The bipartisan legislation streamlines and increases transparency in the approval process for drugs that fall under the Controlled Substances Act (CSA) by creating a specific timeline for the Drug Enforcement Administration (DEA) to schedule certain controlled substances.  The bill also clarifies terminology in the CSA to improve DEA’s ability to work collaboratively with distributors and other stakeholders to prevent drug diversion. 

Senator Hatch said: “Patients can greatly benefit from a modernized, effective approval process for new therapies. These common-sense pieces of legislation place a greater emphasis on transparency and timeliness while preserving DEA’s authority to prevent unsafe therapies from entering the supply chain."

“Giving patients timely access to treatments and ensuring that prescription drugs don’t fall into the wrong hands are important goals, and I’m glad to be working with Senator Hatch to craft legislation to help,” said Senator Whitehouse. 

Key Provisions of the “Improving Regulatory Transparency for New Medical Therapies Act”:

• Improves incentives for medical innovation by amending the Federal Food, Drug, and Cosmetic Act and the Controlled Substances Act (CSA) to require the Drug Enforcement Agency (DEA) to schedule a drug or substance that has never been marketed in the United States within 45 days of receiving a scheduling recommendation from the Secretary of HHS.
• Speeds the development of new therapies by allowing researchers to indicate on their DEA application that the controlled substance will only be used for clinical trials of a drug.

Key Provisions of the “Ensuring Patient Access and Effective Drug Enforcement Act of 2015”:

• Clarifies terminology in the CSA for the terms “consistent with the public health and safety” and “imminent danger” to improve the ability of the DEA to work collaboratively with distributors and other stakeholders to prevent drug diversion.
•  Allows CSA registrants who face having their registration revoked or suspended to submit a corrective action plan.
• Requires the Secretary of Health and Human Services and Administrator of the Drug Enforcement Administration to submit a report to Congress assessing how enforcement activities may impact patient access and identify how collaboration between agencies and stakeholders can benefit patients and prevent prescription drug abuse.