Letter to Shaun Donovan, Director of the Office of Management and Budget - Offering Safe Prescription Drug Disposal Options

Letter

July 31, 2014

Mr. Shaun Donovan
Director
Office of Management and Budget
725 17th Street, NW
Washington, DC 20503

Dear Director Donovan:

In order to ensure that all Americans have a safe and convenient method for disposing of unwanted, unused, or expired prescription drugs, we urge you to complete expeditiously your review of the proposed Disposal of Controlled Substances rule. This rule was transmitted by the Drug Enforcement Administration (DEA) to the Office of Information and Regulatory Affairs (OIRA) on February 25, 2014, and the automatic 90-day review period has expired. We are troubled that the DEA has yet to issue final regulations that could help address the misuse and abuse of unused prescription drugs and are concerned about the extended duration of this rulemaking.

The Secure and Responsible Drug Disposal Act of 2010 authorized the Attorney General to promulgate regulations for delivery of controlled substances by ultimate users for disposal. Attorney General Holder delegated this responsibility for promulgating the Disposal Act implementing regulations to the DEA. After taking public comment and holding a public meeting January 19-20, 2011, the DEA published notice of proposed rulemaking for disposal of controlled substances on December 21, 2012. As of July 2014, the DEA continues to be unable to provide any timetable for approval of the final rule.

Until the DEA finalizes the implementing regulations for the Disposal Act, ultimate users are not permitted to deliver their lawfully obtained controlled substances to any other person for the purpose of disposal other than by surrender to law enforcement or under direction of the area's DEA Special Agent in Charge. The proposed rule would expand the options available for the collection of prescription drugs, including more take-back events, programs to mail-back prescriptions, and increased availability of collection receptacles. Unfortunately, without a final rule the State of Ohio does not have all necessary tools to implement any of these options and get potentially deadly, unneeded prescription medications out of circulation.

President Obama has recognized the importance of providing a responsible and convenient way for people to properly dispose of their prescription drugs and prevent future drug abuse and overdoses. One pillar of the President's 2014 National Drug Control Strategy includes disposal by increasing prescription return/take-back and disposal programs. The July 2014 publication of the Office of National Drug Control Policy's National Drug Control Strategy includes "developing more convenient and environmentally responsible disposal methods to remove unused medications from the home."

As you may know, prescription drug abuse is the fastest growing drug problem in the United States and it affects all age groups, including middle and high school students. In 2012 alone, 1,914 Ohioans died from a drug overdose, and studies show that 70% of abused medications are obtained from families or friends. Therefore, it is imperative that prescription drugs be kept out of the home setting when plausible. Proper disposal methods must be implemented so that we may curb the growing prescription drug abuse problem in the United States.

We urge the DEA to expedite its rulemaking so that proper drug disposal methods are implemented to help curb the growing prescription drug abuse problem in the United States. We urge the agency to carefully consider all stakeholder feedback and work with law enforcement, the public health community, regulatory entities, and supply chain partners to prevent diversion while also protecting patients, healthcare workers, transporters, and the environment. We remain committed to working with you to establish common-sense guidance that will prevent the further abuse of prescription drug medication in Ohio and the rest of the United States. Thank you in advance for your consideration of this request.