Durbin, Kennedy Urge DEA To Use Its New Authorities To Lower Opioid Quotas

https://www.durbin.senate.gov/newsroom/press-releases/durbin-kennedy-urge-dea-to-use-its-new-authorities-to-lower-opioid-quotas

Letter Follows Recent Bipartisan Law And Amendment Yesterday Directing DEA To More Proactively Prevent Big Pharma’s Excessive Opioid Production

WASHINGTON – U.S. Senators Dick Durbin (D-IL) and John Kennedy (R-LA) today, in a letter to Drug Enforcement Administration (DEA) Acting Administrator Uttam Dhillon, called on DEA to use its new authorities—passed into law by Durbin and Kennedy last year—to prevent and limit opioid diversion by properly regulating the pharmaceutical industry and appropriately reducing opioid production quotas for 2020.  In its 2020 proposal, DEA explained it would only lower opioid production quotas based upon reported theft loss and seizures, an inadequate reflection of the abuse, overdose, and public health harms created by excessively high production levels that the DEA approves for drug manufacturers.  The Senators urged DEA to better comply with the 2018 law they passed and not to ignore important health information when setting new opioid production quotas.

“We fear that the explanation provided by DEA for ignoring the clear connection between the staggering volumes of painkillers approved for production and the current overdose epidemic signals that DEA is reverting to the short-sighted approach that precipitated this opioid crisis.  The statute is clear that DEA must exercise its quota authority to serve as a gatekeeper and weigh the public health impact of how many opioids it allows to be sold each year in the United States,” Durbin and Kennedy wrote.

Between 1993 and 2015, the DEA allowed production of oxycodone to increase 39-fold, hydrocodone to increase 12-fold, and fentanyl to increase 25-fold.  As a result, the number of opioid pain relievers dispensed in the United States skyrocketed. The increase in opioid-related overdose deaths has mirrored the dramatic rise in opioid prescribing, with more than 42,000 deaths in 2016.

In 2016, the pharmaceutical industry put 14 billion opioid doses on the market—enough for every adult to have a one-month supply.

Last year, after passage of Durbin and Kennedy’s Opioid Quota Reform Act of 2018, DEA was granted new authorities that enhanced its opioid quota-setting authority by improving transparency and enabling DEA to adjust quotas to prevent opioid diversion and abuse while ensuring an adequate supply for legitimate medical needs.  This is the first year DEA set quotas with the new requirements passed into law. Yesterday, Durbin and Kennedy secured an amendment in the Fiscal Year 2020 Commerce, Justice, and Science funding bill to provide DEA with additional tools to limit the over-production of prescription painkillers. 

After two decades of dramatic increases to the volume of opioids allowed to come to the market, the DEA has heeded Durbin and Kennedy’s repeated calls over the past several years to help prevent opioid addiction by responsibly reducing nearly all opioid quotas.  In part resulting from their efforts with DEA, five powerful, addictive painkillers are set to see a significant reduction in 2020 from what was allowed on the market just four years prior, including a 48 percent cut to oxycodone production over four years; a 59 percent cut to hydrocodone production over four years; and a 65 percent cut to fentanyl production over four years. 

Full text of today’s letter is available here and below:

November 1, 2019

Dear Acting Administrator Dhillon:

We write to comment on the proposed 2020 aggregate production quotas for controlled substances that the Drug Enforcement Administration (DEA) published on September 12.  As DEA finalizes the 2020 aggregate production quotas for schedule II opioids, we strongly urge the agency to consider the public health crisis caused by the opioid epidemic and meaningfully reduce opioids quotas from 2019 levels, as proposed in the Federal Register notice.

As our nation confronts the worst drug overdose epidemic in its history, we write to urge the Drug Enforcement Administration (DEA) to tackle the opioid crisis by utilizing new authorities that Congress provided to establish more sensible opioid production quotas for 2020.  The Opioid Quota Reform Act, which was signed into law as Section 3282 of the SUPPORT for Patients and Communities Act (P.L. 115-271), strengthened DEA’s statutory quota-setting authority by enhancing transparency and requiring opioid quotas to be adjusted to reflect diversion, overdose deaths, and public health.  As the bipartisan authors of that legislation, we strongly encourage you to use this new authority to rein in the pharmaceutical industry’s incessant demand for excessive levels of opioid production. 

We have previously shared our deep concern that, between 1993 and 2015, DEA allowed aggregate production quotas for oxycodone to increase 39-fold, hydrocodone to increase 12-fold, hydromorphone to increase 23-fold, and fentanyl to increase 25-fold.  Recent reporting from the Washington Post revealed that the pharmaceutical industry flooded every corner of the country with 76 billion oxycodone and hydrocodone pills between 2006 and 2012—outsized and unjustifiable volumes of painkiller production undertaken with DEA approval and awareness. 

The October 1 report from the Department of Justice’s Inspector General specifically highlighted that, while the opioid epidemic surged, “DEA was authorizing manufacturers to product substantially larger amounts of opioids.”  While we appreciate the initial steps taken in recent years to reduce the aggregate production quotas for schedule II opioids, we remain concerned that they are still far too high. 

Approximately thirteen billion opioid doses were put on the market in 2017—enough for every adult American to have at least a three-week prescription of painkillers.  As powerful painkillers are aggressively marketed and prescribed at high rates, this sheer volume of available opioids heightens the risk for illicit diversion and abuse.  For example, four in five new heroin users first began their addiction with prescription painkillers.

DEA explained in its proposed rule that its estimate of diversion—for the purpose of setting the aggregate production quotas—was based upon reported theft loss and seizures, and that DEA could not use Medicaid sales data or drug overdose and death data from the Centers for Disease Control and Prevention (CDC).  While we appreciate the challenges in directly linking patient overdoses to a specific controlled substance, DEA cannot ignore or discard this essential information from the quota-setting process.  DEA stated that, “illicit manufacturing cannot be tempered by adjusting the aggregate production quotas”, but this fails to acknowledge the potential impact that such adjustments may have on illicit demand. 

We fear that the explanation provided by DEA for ignoring the clear connection between the staggering volumes of painkillers approved for production and the current overdose epidemic signals that DEA is reverting to the short-sighted approach that precipitated this opioid crisis.  The statute is clear that DEA must exercise its quota authority to serve as a gatekeeper and weigh the public health impact of how many opioids it allows to be sold each year in the United States.     

As DEA finalizes the opioid production quotas for 2020, we urge you to apply DEA’s new authorities to prevent and limit opioid diversion due to excessively high production levels.  Thank you for your commitment to addressing the opioid epidemic.  We look forward to our continued engagement on this issue.

Sincerely,

According to this website https://www.reference.com/world-view/many-adults-live-usa-b830ecdfb6047660  there is abt 248 million adults in the USA..

Using the numbers in this article In 2016, the pharmaceutical industry put 14 billion opioid doses on the market—enough for every adult to have a one-month supply

Using those numbers means that each adult would get abt 60 doses of a opiate.

Using the normal number of chronic pain pts being 100 million… so it would suggests that abt 40% of the adults are chronic pain pts.

So if anyone wanted to do the math for 100 million chronic pain pts taking one opiate dose twice a day (60 doses/month) they would need 72 BILLION doses of opiates. Abt FIVE TIMES what Sen Durbin & Kennedy believes is an excessive amount of opiate production.

Within that 72 billion doses, does not provide any opiate doses for acute pain management… a hard to calculate number.

To put it another way… presuming that SIXTY DOSES/MONTH would provide adequate pain management for the 100 million chronic pain pts… ONLY ONE IN FIVE  (20%)  CHRONIC PAIN PTS would get adequate pain management.

Of course, there is no mention as to what mgs or what opiates they came up with this excessive opiate production.

It is also stated in the letter that in a SEVEN YEAR PERIOD  pharmaceutical industry flooded every corner of the country with 76 billion oxycodone and hydrocodone pills between 2006 and 2012. The pharmas produced enough oxycodone & Hydrocodone to potentially provide adequate pain management for chronic pain pts for a ONE YEAR PERIOD…again no provision for pts dealing with acute pain nor any considerations for high impact/intractable chronic pain pts nor pts that are fast/ultra fast metabolizers that need higher and/or more frequent doses.

Within the time frames that they claim there was excessive opiate production was during the “Decade of pain” that encourage prescribers to treat pain as the “5th vital sign” in a bill/law from the 106th Congress https://www.congress.gov/bill/106th-congress/house-bill/2260

This seems to follow a pattern with Congress… in 1914 they passed the Harrison Narcotic Act – which created the “black drug market” and then in 1970 they passed the Controlled Substance Act that declared a “war on drugs” that the 1914 act created… then in 2000 the “Decade of Pain” encourage prescribers to treat pain as the “5th vital sign”… now we are seeing Congress attempting to take corrective action from the outcomes of the 2000 law.

Maybe it is this sort of things that caused Einstein to create his infamous definition of “insanity” ?

Or is Congress like a dog chasing their tail, expending a lot of energy and revenue and getting no where ?

 

Filed under: General Problems