Judiciary Committee Passes Six Bills in Fight against Opioid Crisis

The Senate Judiciary Committee recently advanced six bipartisan bills aimed at combatting the ongoing opioid epidemic. The bills focus largely on enhancing enforcement and reducing the misuse of prescription opioids.

 

 

Opioid abuse often begins when prescription opioids are misused by a patient or are obtained and used by someone else, which is known as diversion. Certain retail pharmacies are authorized to voluntarily collect unused prescription drugs from the public to reduce diversion. However a recent GAO study found that only 3 percent of eligible pharmacies and other entities were participating in take-back programs.

 

This bill:

·        Encourages increased participation in drug take-back programs through grants to states. Five states will be awarded grants, with no less than three of them being states within lowest quartile of participation in take-back programs. States may then choose a state agency that will administer and distribute grant funding to eligible collectors.

·        Requires states to report to Congress on how the grant funding was used and how it changed participation rates in take-back programs.

 

 

Millions of opioids have been distributed to pharmacies in the United States, increasing the potential for abuse when the supply outpaces quantities needed to fill legitimate prescriptions. For example, between 2006 and 2016, nearly 21 million opioids were distributed to two pharmacies in Williamson, W.Va., which has a population of about 3,000. Between 2007 and 2012, 780 million oxycodone and hydrocodone pills were distributed to pharmacies throughout West Virginia. During this same timeframe, these two drugs contributed to 1,700 drug overdose deaths in the state. While manufacturers and distributors of opioids are required to report sales and deliveries of narcotics to DEA, DEA is not required to disclose the total number of distributors serving a single pharmacy or probationer or the total quantity and type of opioids being distributed.

 

This bill:

·        Requires DEA to share anonymized information with manufacturers and distributors, including the total number of distributors serving a single pharmacy or practitioner, and the total number of opioid pills distributed to a single pharmacy or practitioner.

·        Requires DEA to share information on opioid orders to help identify statistical trends and outliers.

·        Increases civil and criminal penalties for violations by drug manufacturers and distributors.

·        Requires a report to Congress on DEA’s use of data to identify and stop suspicious opioid orders.

 

 

DEA sets annual quotas for the exact amount of each opioid drug that is permitted to be produced in the United States. However, DEA is only authorized to consider certain factors such as past sales and estimated demands when setting production quotas. In the last three decades, total opioid production has increased significantly.

 

This bill:

·        Requires that DEA consider additional factors when setting annual quotas, such as opioid diversion, abuse, overdose deaths, and public health impacts.

·        Requires DEA to explain how any annual quota increase outweighs potential harmful consequences.

·        Requires DEA to report statistical data to Congress on the number of manufacturers that DEA authorizes to produce opioids each year, and how many manufacturers’ quotas increased over the previous year.

·        Allows DEA to consider variations in dosage forms when setting quotas.

 

 

While the sale and distribution of certain synthetic drugs that are substantially similar to controlled substances (analogues) is prohibited, there is a carve-out in existing law for substances that are “not intended for human consumption.” As a result, analogues are often marketed as products not intended for human consumption, thwarting effective prosecution.

 

This bill:

·        Closes the existing loophole by allowing the consideration of additional factors when determining whether a controlled substance analogue is intended for human consumption including:

o   The marketing of a substance and its known efficacy for the marketed purpose;

o   The difference between sale price and marketed price;

o   The covert importation of a substance or known diversion from legitimate channels; and

o   Whether the defendant knew or should have known that the substance was intended to be used as a drug.

 

 

Congressional authorization Office of National Drug Control Policy (ONDCP) expired in FY2010. Since 2010, ONDCP has received federal funds, but is in need of updated reauthorizing legislation, particularly to help address the opioid crisis.

 

The bill:

·        Reauthorizes ONDCP.

·        Explicitly clarifies that the Drug Free Communities and High-Intensity Drug Trafficking Area programs should remain within ONDCP.

·        Provides grant program funds to equip and protect law enforcement officers that come in contact with Fentanyl and other substances, and provides training on how to be safe when coming in contact with those substances.

·        Encourages expanding awareness campaigns and prevention efforts in CARA.

·        Establishes best practices for states on interventions and strategies for keeping families affected by substance use disorder together.

·        Creates grant programs to provide support for training non-physician healthcare professionals in the use of medication-assisted treatment.

·        Makes grants to states for to establish or expand Sobriety Treatment and Recovery Team programs to determine the effectiveness of pairing social workers and mentors with families struggling with substance abuse.

 

 

DEA has sought clarity from Congress on how the agency, pharmaceutical distributors and other industry members can better identify and address suspicious opioid orders that may fuel increased diversion. Those entities are currently limited by a narrow definition of “suspicious orders.”

 

This bill:

·        Amends the Controlled Substances Act to define the criteria for a “suspicious order” to include unusual size of an order, an order that deviates substantially from a normal pattern and an order of unusual frequency.

·        Requires industry members to identify and notify DEA of any suspicious orders.

·        Establishes a centralized database to collect reports of suspicious orders.

·        Requires data on suspicious orders to be shared with states.

·        Requires a report to Congress on the database, the data provided to states, and how the bill impacted the reporting of suspicious orders.