Washington, D.C. – The House of Representatives tonight passed the Ensuring Patient Access and Effective Drug Enforcement Act, introduced by Senators Orrin Hatch (R-UT) and Sheldon Whitehouse (D-RI), which would help ensure that prescription drugs are dispensed to patients who need them and not those who would abuse them. The Hatch-Whitehouse bill clarifies the standards companies must meet when seeking to prevent prescription drugs from being diverted toward improper uses and helps protect patients from dangerous disruptions in the production and delivery of their prescription drugs. Having already passed the Senate unanimously, the bill now goes to the President to be signed into law.
“Prescription drug abuse is a big problem in Utah. A recent study found that our state ranks fifth in the nation in drug overdose deaths. That’s why I’m so glad Congress has passed the Ensuring Patient Access and Effective Drug Enforcement Act to encourage greater collaboration between law enforcement and the private sector in fighting prescription drug abuse. This bill will motivate drug manufacturers, distributors, and pharmacies to step up efforts to prevent diversion of drugs for improper purposes. At the same time, it will put in place safeguards to ensure that patients who truly need medications are able to get them. I’m looking forward to the President signing this important bill into law,” said Hatch.
“This bill strikes an important balance between ensuring patients have the prescriptions they need and protecting against illegal trafficking of powerful controlled substances,” said Whitehouse, whose comprehensive legislation to combat the addiction crisis nationwide passed the Senate last month. “It will offer better guidance for companies working to safeguard prescription drugs headed to market, and promote better communication between companies and regulators so patients have reliable access to their prescriptions.”
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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