dea report on the ensuring patient access and effective drug enforcement act

According to former DEA officials cited in The Washington Post report, the Ensuring Patient Access and Effective Drug Enforcement Act of 2016 changed the evidentiary threshold that the DEA needed to meet to a harder standard when seeking to suspend drug companies’ registration.

Full Answer

What is the DEA?

It modified the Controlled Substances Act, which requires the Drug Enforcement Administration (DEA) to identify "imminent danger to the public health and safety" before suspending the registration of a manufacturer, distributor, or dispenser for controlled substances privileges.

When was the Drug Enforcement Act passed?

Committee consideration by Senate Judiciary Committee. Passed the Senate on March 17, 2016. Passed the House on April 12, 2016. Signed into law by President Barack Obama on April 19, 2016. The Ensuring Patient Access and Effective Drug Enforcement Act of 2016 is a United States federal statute enacted by the 114th United States Congress ...

What is the role of the DEA?

As the primary regulator of controlled substances, DEA has the responsibility and capability to take action against diversion, yet the agency’s actions often ran counter to those goals. 1 Registrants: The DEA has primary regulatory authority when it comes to licensing the entities who are prescribing, distributing and dispensing controlled substances, including when to suspend or revoke a license. The DEA regularly increased the number of registrants who were prescribing and dispensing controlled substances on a yearly basis. 2 Annual Production Quotas: The DEA sets the annual production quotas for opioids based on “legitimate medical need” and determines the amount of opioids that can be manufactured each year. From 2004 to 2013, the DEA increased production of controlled substances, effectively adding to the supply of opioids on the market. For example, the DEA approved increased production of oxycodone during this time by 39-fold.

What is the DEA quota?

Annual Production Quotas: The DEA sets the annual production quotas for opioids based on “legitimate medical need” and determines the amount of opioids that can be manufactured each year. From 2004 to 2013, the DEA increased production of controlled substances, effectively adding to the supply of opioids on the market.

What is HDA in healthcare?

The Healthcare Distribution Alliance (HDA) represents primary pharmaceutical distributors — the vital link between the nation’s pharmaceutical manufacturers and pharmacies, hospitals, long-term care facilities, clinics and others nationwide. Since 1876, HDA has helped members navigate regulations and innovations to get the right medicines to the right patients at the right time, safely and efficiently. The HDA Research Foundation, HDA’s non-profit charitable foundation, serves the healthcare industry by providing research and education focused on priority healthcare supply chain issues.

What is the GAO?

The Government Accountability Office (GAO) recognized that a lack of communication from DEA to distributors was hampering efforts to effectively combat prescription drug diversion. In its July 2015 report, GAO stated, “The lack of awareness among registrants of DEA resources and conferences suggests that DEA may not have an adequate means ...

Who has primary regulatory authority when it comes to licensing the entities who are prescribing, distributing and dispensing

Registrants: The DEA has primary regulatory authority when it comes to licensing the entities who are prescribing, distributing and dispensing controlled substances, including when to suspend or revoke a license. The DEA regularly increased the number of registrants who were prescribing and dispensing controlled substances on a yearly basis.

Can the DEA issue an ISO?

Under the CSA, the DEA is able to issue an ISO if there is an imminent danger to public health or safety. However, there was no federal definition of what constitutes an “imminent danger.”. As a result, the DEA had unfettered ability to immediately suspend a registrant’s ability to handle prescription drugs.

What is S. 483?

S. 483 (114. ): Ensuring Patient Access and Effective Drug Enforcement Act of 2016. Library of Congress. We don’t have a summary available yet. The summary below was written by the Congressional Research Service, which is a nonpartisan division of the Library of Congress, and was published on Apr 20, 2016.

What does "imminent danger to public health and safety" mean?

This bill defines "imminent danger to the public health and safety" to mean an immediate threat of death, serious bodily harm, or abuse of a controlled substance due to a registrant's failure to maintain effective controls against diversion.

How does the DEA work?

DEA works with its registrant population by: (1) hosting Pharmacy Diversion Awareness Conferences (PDACs) throughout the country; (2) administering the Distributor Initiative Program with a goal of educating distributors on how to detect and guard against diversion activities; and (3) maintaining an open dialogue with various national associations such as the National Association of Boards of Pharmacy (NABP), American Medical Association (AMA), and other groups to address diversion problems and educate the medical community on improving prescribing practices.8 As of November 2017, DEA has hosted 100 PDACs in all 50 states (and the District of Colombia and Puerto Rico) resulting in the training of more than 13,300 pharmacists, pharmacy technicians, and others on the important role they play in ensuring that valid prescriptions for controlled substances are filled. In 2018, DEA will initiate a nationwide program to offer similar training to individual practitioners.

What is the DEA's role in the opioid epidemic?

In addition to the actions of the Diversion Division, DEA continues to aggressively combat the opioid epidemic through a variety of enforcement and partnership efforts. The DEA Special Operations Division (SOD) Heroin/Fentanyl Task Force (HFTF) Working Group consists of several agencies using a joint “whole of government” approach to counter the fentanyl/opioid epidemic in the United States. The HFTF consists of personnel from DEA, U.S. Immigration and Customs Enforcement Homeland Security Investigations (HSI) and Customs and Border Protection (CBP); supplemented by the Federal Bureau of Investigation (FBI) and the U.S. Postal Inspection Service. HFTF utilizes every resource available, including support from the Department of Justice’s Organized Crime Drug Enforcement Task Forces (OCDETF) Fusion Center (OFC) and Criminal Division, the Department of Defense (DOD), Intelligence Community (IC) and other government entities, and provides field offices (all agencies) with valuable support in their respective investigations.

What is the opioid epidemic?

The United States continues to be affected by a national opioid epidemic, which has been spurred, in part, by the rise of abuse of prescription opioids. DEA’s Diversion Control Division will continue to use all criminal and regulatory tools possible to identify, target, disrupt, and dismantle individuals and organizations responsible for the illicit distribution of pharmaceutical controlled substances in violation of the CSA. We look forward to continuing to work with Congress to find solutions necessary to address the threats posed by controlled prescription drugs, heroin, and fentanyl.

What is the DEA's mission?

One of the DEA’s most critical missions in the fight to address this crisis is to prevent and combat the diversion of controlled substances. Congress designed the Controlled Substances Act to give DEA the ability to issue ISOs to suspend a registration in those instances when DEA concludes that the continued registration represents an imminent danger to public health or safety or the registrant fails to comply with statutory control standards. The “Ensuring Patient Access and Effective Drug Enforcement Act of 2016” (EPAEDA or the Act), by defining “imminent danger,” conditioned the issuance of an ISO on a determination that there is a “substantial likelihood of an immediate threat of death, serious bodily harm, or abuse of a controlled substance” due to the failure of the registrant to maintain effective diversion controls.

What is DEA diversion control?

DEA’s Diversion Control Division has also taken numerous steps to examine sales and monitoring processes. For example, Diversion Control utilizes various reports and records to monitor trends or determine anomalous transactions, which can then be developed into investigative leads. A unit within the Diversion Control’s Pharmaceutical Investigations Section uses aggregated ARCOS data to identify patterns and trends in the flow of narcotic controlled substances through the closed system of drug distribution. This unit is now proactively preparing quarterly threat assessment reports for each of DEA’s 22 Field Divisions to prioritize DEA’s limited resources in furtherance of criminal, civil and regulatory investigations. DEA is working collaboratively with a coalition of 41 States Attorneys General to provide non-public, law enforcement sensitive ARCOS data to support their active investigations against certain manufacturers and distributors.

What is the DEA 360 strategy?

To counter the opioid crisis, DEA continues to expand its 360 Strategy, a comprehensive three-pronged approach tackling the cycle of violence and addiction generated by the link between drug cartels, violent gangs, and the rising problem of prescription opioid misuse and heroin use in U.S. cities. The 360 Strategy features: coordinated law enforcement actions against drug cartels and heroin traffickers in specific communities; diversion actions against DEA registrants operating outside the law and long-term engagement with pharmaceutical drug manufacturers, wholesalers, pharmacies, and practitioners; and community outreach through local partnerships that empower communities to take back affected neighborhoods after enforcement actions and prevent the same problems from cropping up again. In 2016, DEA implemented its 360 strategy in Louisville, Kentucky, Milwaukee, Wisconsin, St. Louis, Missouri, and Pittsburgh, Pennsylvania. In 2017, DEA implemented its strategy in Dayton, Ohio, Albuquerque, New Mexico, Charleston, West Virginia, and Manchester, New Hampshire. In 2018, we are implementing this program in Salt Lake City, Utah, as well as other cities yet to be announced.

What is the DEA's final rule?

On September 9, 2014, DEA issued a final rule, titled “Disposal of Controlled Substances.” These regulations implement the Secure and Responsible Drug Disposal Act of 2010 and expand upon the previous methods of disposal by including disposal at drop-boxes in pharmacies and law enforcement agencies, mail-back programs and drug deactivation systems if they render the product irretrievable. Through these regulations, DEA continues to focus its national attention on the issue of the misuse of prescription drugs and related substance use disorders (SUDs), and promotes awareness that one source of these drugs is often the home medicine cabinet, as 53% of persons aged 12 or older who misused pain relievers in the past year bought or took the pain relievers from a friend or relative, or that friend or relative gave it to the user for free.9 These regulations provide a safe and legal method for the public to dispose of unused or expired CPDs. As of November 30, 2017, 2,948 DEA registrants have become “authorized collectors.”