February 11, 2016

Judiciary Committee Passes Hatch-Whitehouse Bill to Improve Enforcement and Monitoring of Prescription Drugs

Washington, D.C. – This morning, the Senate Judiciary Committee passed legislation to help ensure that prescription drugs get to the patients who need them and not onto the streets where they can be abused.  The bipartisan Ensuring Patient Access and Effective Drug Enforcement Act, authored by Senators Orrin Hatch (R-UT) and Sheldon Whitehouse (D-RI), would clarify the standards companies must meet when protecting prescription drugs from being diverted toward improper uses and help protect patients from dangerous disruptions in the production and delivery of their prescription drugs.

“We need greater cooperation between law enforcement and the drug companies, distributors, and pharmacies in the drug supply chain in responding to and fighting the nation’s prescription drug epidemic.  The promise of prescription drugs to cure and heal need not be undermined by the harm they cause when misused.  This legislation takes important steps toward keeping people safe,” said Hatch.

“Prescription drugs can cure illness and calm excruciating pain, but they can also wreak havoc if they aren’t used the right way or by the right people,” said Whitehouse.  “Right now, companies that manufacture and distribute prescription drugs, and the federal officials responsible for protecting the public from drug abuse, lack effective guidelines to establish which companies should be registered and regulated.  This bill will bring clarity to this murky process, and encourage greater communication between companies and their federal regulators to ensure patients have access to their medications while abusers can be identified.”

Currently, the Controlled Substances Act (CSA) does not make clear which factors the Drug Enforcement Agency (DEA) should consider when deciding whether to register a company applying to manufacture or distribute prescription drugs.  Hatch and Whitehouse’s legislation directs the DEA to use findings Congress compiled while drafting the CSA to define those factors.  The bill also describes the circumstances under which the Attorney General can suspend a company’s registration.  Finally, it allows companies that violate the CSA an opportunity to work with the DEA to correct the violation before having their registration revoked.

A summary of key provisions of the bill can be found here.

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