Senate passes Ensuring Patient Access and Effective Drug Enforcement Act
WASHINGTON — The Senate this week 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 Sens. Orrin Hatch, R-Utah, and Sheldon Whitehouse, D-R.I. and advocated by the National Association of Chain Drug Stores, 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 U.S. House of Representatives passed its largely similar version of the bill (H.R. 471) in April 2015. Congressional leaders will need to determine the best path to achieving passage of the exact same legislative language in both chambers, so the bill can advance to the President.
“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.”
“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," Whitehouse added.
In late February, NACDS sent a letter to members of the U.S. Senate, urging the passage that was achieved yesterday. “NACDS appreciates the diligence that has brought this legislation to the brink of enactment,” commented Steven Anderson, NACDS president and CEO. “Throughout, NACDS has emphasized pharmacy’s commitment to a zero-tolerance for abuse and diversion, and a 100% commitment to patient care. This legislation will help to deliver on that vision."
"The passage of S. 483, coupled with Senate’s approval of the Comprehensive Addiction and Recovery Act (S. 524), substantially enhances the range of tools now available to regulators, supply chain stakeholders and the broader healthcare community to effectively address the prescription drug abuse epidemic," added John Gray, president and CEO of the Healthcare Distribution Management Association.
NACDS and HDMA have both expressed strong support for this legislation.
According to the Senators, the Controlled Substances Act currently does not make clear which factors the Drug Enforcement Agency 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.
NACDS has noted that the steady progress of the legislation in the Congress can be considered to be highly consistent with public attitudes. In an opinion study commissioned by NACDS last summer, likely voters who are engaged and aware when it comes to current events indicated through their responses an appreciation for the need to address drug abuse and drug access in a complementary manner.
Nearly 8-in-10 respondents agreed with the statement: “Pharmacies have a dual role when it comes to battling prescription drug abuse: They have to be part of the solution by working with law enforcement officials to stop prescription drug abuse, but they also have to maintain their responsibilities to patients by making sure they receive the medications they legitimately need.”