March 21, 2016

Hatch and Whitehouse’s Ensuring Patient Access and Effective Drug Enforcement Act Passes Senate

Washington, D.C. – Today, the Senate unanimously passed the Ensuring Patient Access and Effective Drug Enforcement Act, to help ensure that prescription drugs land in the hands of patients and not those who would abuse them.  The bill, 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.  The bill now awaits action in the House.

“Prescription drug abuse is a complicated and troubling trend that requires better coordination between drug manufacturers and law enforcement,” Hatch said. “The fact that prescription drugs can be abused should not prevent patients from receiving the medications they need. This bill takes a balanced approach to the problem of prescription drug abuse by clarifying penalties for manufacturing or dispensing outside approved procedures while helping to ensure that supply chains to legitimate users remain intact. It will encourage companies to notify law enforcement proactively when they discover potential diversion and to work with officials to help keep these drugs in the right hands.”

“When used correctly, prescription drugs can provide patients with lifesaving treatments. However, they can be tremendously harmful when abused,” said Whitehouse.  “We can avoid some of that harm if we can keep prescription drugs from being diverted into the wrong hands.  By offering better guidance for companies in the prescription drug supply chain, and by promoting better communication between those companies and federal regulators, this bill can help fight drug abuse and ensure that patients have access to their prescriptions.  I was very glad to see it pass unanimously today.”

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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