Call To Action

SIGN ONTO FED UP! COALITION’S LETTER TO US ATTORNEY GENERAL WILLIAM BARR
WE WANT JUSTICE!

We urge your organization to join this initiative in solidarity with FED UP!. To sign the letter displaying your support, please email John McCally john.mccally@feduprally.org with your organization’s name, city and state.  Deadline to sign the letter is extended to Friday, August 28th at 6 PM CST.

Re: Justice for Victims of the Opioid Crisis

Dear Attorney General Barr:

On behalf of dozens of organizations and millions of families devastated by the opioid crisis, we write in hope of obtaining justice for the victims of opioid industry executives.

A federal judge presiding over hundreds of county and state cases against opioid manufacturers and distributors recently stated: “It is accurate to describe the opioid epidemic as a man-made plague, 20 years in the making.”[1] This man-made plague was created by the opioid industry—the companies that manufacture, and distribute prescription opioids. The President’s Commission on Combatting Drug Addiction and the Opioid Crisis also pointed to the role played by opioid manufacturers and distributers in causing the opioid crisis, highlighting as causes the “aggressive promotion of [OxyContin],” an industry campaign to treat pain like “the Fifth Vital Sign,” and “unrestrained distributors.” [2] Of note, the opioid industry continues to impede efforts to reduce the supply of opioids. As the President’s Commission observed “To this day, the opioid pharmaceutical industry influences the nation’s response to the crisis,” citing front group opposition to the CDC opioid guideline as but one example.

While we are encouraged by reports that the Department is pursuing $18.1 billion in penalties from Purdue Pharma after uncovering evidence of criminal and civil misconduct,[3] we urge the Department of Justice to hold members of the Sackler family and other Purdue executives personally responsible for their criminal acts in furtherance of their company’s wrongdoing.

We further urge the Department to pursue criminal charges against executives from other companies who, like the Sacklers, broke the law in their pursuit of profit and took actions that harmed millions of Americans. Senior executives from AmerisourceBergen, Cardinal Health, Endo Pharmaceuticals, Johnson & Johnson, Mallinckrodt, McKesson, Teva (Cephalon) and other companies, must be brought to justice as individuals.

An important lesson from the opioid crisis is that fines and settlements paid by opioid manufacturers and distributors are not an adequate deterrence. It is clear from their actions that the individuals controlling these companies see fines and settlements as the cost of doing business. For example:

  • In 2007, Purdue Pharma was fined $634.5 million for its deceptive marketing campaign. Had members of the Sackler family been held individually accountable for Purdue’s wrongdoing in 2007, they would likely have refrained from engaging in a criminal kickback scheme with an electronic health records vendor.[4] And criminal action taken against the Sacklers would likely have deterred other opioid industry executives from engaging in similar behavior.
  • In 2007 and 2008, AmerisourceBergen, Cardinal Health and McKesson were held liable and fined by the Department of Justice for improperly distributing opioids. If senior executives had been held individually accountable for their illegal and reckless behavior, their companies would likely have changed their ways.[5] Instead, they would continue to break the law year after year, continue to pay fines, and continue to flood states and counties with hundreds of millions of opioid pills.
  • In 2008, Teva (Cephalon) was convicted for committing a felony and paid $425 million in criminal and civil penalties for off-label marketing of its fentanyl lollipop (Actiq) but the executives responsible for the company’s criminal behavior were never charged or fined.[6] Had the bad actors been prosecuted, Teva would likely not have repeated the exact same criminal behavior with its off-label marketing of a fentanyl lozenge (Fentora) and Insys would likely have been deterred from bribing doctors to prescribe its fentanyl spray (Subsys) off-label.[7]
  • In 2009, Johnson and Johnson (J&J)was caught violating federal law by downplaying the risks of tramadol (Ultram ER).[8] In 2011, J&J was again caught downplaying opioid risks.[9] Had J&J’s executives been held personally accountable, their company’s improper marketing of opioids would likely have ceased. Instead, J&J would continue to improperly promote its opioid products and fund front groups that downplayed opioid risks.[10]

It is important to recognize that the actions described above led to millions of cases of opioid addiction and more than 500,000 deaths since 1999. While families emptied their bank accounts seeking treatment for their loved ones, executives responsible for the opioid crisis have acted with impunity and accrued immense wealth.

The trajectory of the opioid crisis would likely have been far less severe if, from the beginning, opioid industry executives were prosecuted for the actions they took that led to addiction and death. But it is not too late to act. On behalf of the millions of victims of the opioid industry, we urge the Department of Justice to hold these individuals accountable to the fullest extent of the law.

Sincerely,


[1] Feeley J. Opioid-industry claims proceed as judge cites “man-made plague.” Bloomberg News. December 20, 2018. https://www.bloomberg.com/news/articles/2018-12-20/opioid-industry-claims-proceed-as-judge-cites-man-made-plague.

[2] Cite

[3] Randazzo S. Justice Department Seeks as Much as $18.1 Billion From Purdue Pharma. Wall Street Journal. August 4, 2020.

[4] Spector M, Hals T. Exclusive: OxyContin maker Purdue is ‘Pharma Co X’ in U.S. opioid kickback probe. Reuters. January 28, 2020.

[5] Drug Topics, DEA hits third Cardinal Health distribution center, December 21, 2007, available at https://www.drugtopics.com/pharmacy/dea-hits-third-cardinal-health-distribution-center. Drug Topics, Cardinal caught between DEA and pharmacies over diversion control, April 14, 2008, available at https://www.drugtopics.com/community-practice/cardinal-caught-between-dea-and-pharmacies-over-diversion-control. May 2, 2008 Settlement and Release Agreement and Administrative Memorandum of Agreement between DEA and McKesson Corporation, available at https://www.dea.gov/sites/default/files/2018-06/Pharmaceutical%20Agreements%20-%20McKesson%20-%202008_0.pdf.

[6] https://www.justice.gov/archive/opa/pr/2008/September/08-civ-860.html

[7] https://www.justice.gov/usao-ma/pr/founder-and-former-chairman-board-insys-therapeutics-sentenced-66-months-prison

[8] Letter from FDA to William Weldon, Chairman of the Board and Chief Executive Officer

Johnson & Johnson, RE: NDA# 21-692, ULTRAM® ER (tramadol HCl) Extended-Release Tablets. MACMIS # 17464;

[9] Letter from FDA to Roxanne O. McGregor-Beck RE: NDA # 022304 NUCYNTA® (tapentadol) immediate-release oral tablets C-II MA # 147

[10] Hoffman J. Johnson & Johnson ordered to pay $572 million in landmark opioid trial. New York Times. August 26, 2019. https://www.nytimes.com/2019/08/26/health/oklahoma-opioids-johnson-and-johnson.html.

CARE ACT – WE NEED FEDERAL FUNDING FOR TREATMENT

Treatment is the most vital component in dealing with the opioid addiction epidemic. Treatment saves lives. Due to advocacy efforts, treatment is more available now than it was. In 2016, the NSDUH survey showed that 453,000 (21.6%) Americans with OUD received treatment for OUD. In 2017, that number rose to 603,000 (28.6%).  But this is far short of what is needed.

Obtaining treatment continues to be a real challenge to those with OUD. In general, accessing treatment remains more difficult than getting drugs. We have no simple universal route into treatment, no place where a patient can simply show up and be guaranteed entry. And the power of addiction is such that the OUD patient needs help now, or the opportunity for treatment may be lost.  Difficulty accessing treatment often results in no treatment at all.

Medicaid has provided simpler entry into treatment.  Americans with OUD who are on Medicaid are significantly more likely to receive OUD treatment (43%) than those who are uninsured (21%) or have private insurance (23%).   It is ironic that so few of those with private insurance are receiving OUD treatment, but many of those with insurance who have attempted to obtain treatment can attest to what a frustrating experience it can be. 

              Obamacare (The Affordable Care Act) made Medicaid available to millions of Americans living in the 36 states that accepted the terms of Medicaid Expansion, under which Medicaid eligibility criteria rose from 43% of the poverty line to 138% of the poverty line, making Medicaid newly available to 12.7 million Americans.  This has been of great value to the working poor needing OUD treatment.

              But 14 states did not accept the terms of Medicaid expansion.  Obtaining Medicaid is not possible in those states for many of the 2.2 million people in those states whose income falls between 43% and 138% of the poverty line.  These are the working poor who make too much money to be on Medicaid and are too poor to afford Obamacare insurance, even with subsidies.

Worse, the proposed 2019 Federal Government Budget would eliminate Medicaid for the 12.7 million Americans only recently covered by Medicaid expansion. 

              Over the past few years, the federal government has enacted several pieces legislation designed to improve the prospects of treatment for those with OUD.  These include The Comprehensive Addiction and Recovery Act (CARA), the 21st Century Cures Act, The Omnibus Spending Bill of 2018, and the SUPPORT for Patients and Communities Act of 2018 (see * below for elaboration on these pieces of legislation.) 

None of these have been comprehensive in the way that the successful Ryan White Comprehensive AIDS Resources Emergency Act of 1990 was. The Ryan White Act committed the federal government as the payer of last resort for treatment for all those with HIV or AIDS. None of these allow an OUD patient a guaranteed path of entry into treatment.  And the current legislation does not make a commitment to sustained funding. It is unreasonable to expect people to build a clinic knowing that the funding for treatment could dry up in 2 years.

And parts of the current legislation came with a price which undermined its very goals. The ACA did not allow Medicare to negotiate drug prices with manufacturers 

Last year, Sen. Elizabeth Warren (D-Mass.) and Rep. Elijah Cummings (D-Md.) introduced the Comprehensive Addiction Resources Emergency Act, a bill that would provide $10 billion per year over 10 years to deal with the opioid addiction epidemic.  This bill is modeled after the Ryan White Act.

A major step of this kind is vital if we are to develop easy availability of treatment for all those afflicted with OUD and truly diminish the impact of this epidemic.  Please contact your Congressman and Senators.

REPEAL The Ensuring Patient Access and Effective Drug Enforcement Act of 2016

The FED UP! Coalition also asks that you contact your Congressional representatives to repeal the Ensuring Patient Access and Effective Drug Enforcement Act since, as we wrote in a letter to the appropriate Congressional Chairmen, “the law constrains the D.E.A.’s ability to enforce the Controlled Substances Act and allows perpetrators of illegal opioid distribution to act with impunity.”

The Ensuring Patient Access and Effective Drug Enforcement Act dramatically increased the standard of proof required for the D.E.A. to suspend a D.E.A. registration. The law was passed because it was falsely promoted as a way to ensure patient access to narcotics and improve cooperation between the D.E.A. and industry. In reality, the law constrains the D.E.A.’s ability to enforce the Controlled Substances Act and allows perpetrators of illegal opioid distribution to act with impunity.

On Sunday, Oct 15, 2017, the Washington Post and 60 Minutes jointly brought national attention to this legislation and its impact to the D.E.A.’s ability to protect public health. The news coverage provided multiple examples of opioid distributors willfully neglecting their responsibility to report suspicious prescription opioid orders.

It is time for Congress to act. Until this law is repealed, the D.E.A.’s ability to enforce the Controlled Substances Act will be hampered. Repealing this law will save lives and help bring the nation’s most urgent public health crisis under control. Please contact your Congressman and Senators and urge them to Repeal this bill.

SOFA Act

WRITE YOUR CONGRESSIONAL REPRESENTATIVE TODAY!

IMPLORE HIM OR HER TO SUPPORT THE SOFA ACT (H.R. 2935).  THE SOFA ACT AMENDS THE CONTROLLED SUBSTANCES ACT TO ADD ILLICIT FENTANYL ANALOGS TO SCHEDULE I.

THIS LEGISLATION IS A MUST IN THE FIGHT AGAINST FENTANYL ANALOG OVERDOSE DEATHS.

POINT OUT THAT CHINESE CHEMICAL MANUFACTURERS SWITCHED FROM MAKING FENTANYL TO MAKING MULTIPLE FENTANYL ANALOGS BECAUSE INTRODUCING MULTIPLE FENTANYL ANALOGS MADE IT EASIER TO GET AROUND THE U.S. LAWS.

POINT OUT THAT WHEN THE DEA ENACTED REGULATIONS PLACING FENTANYL ANALOGS IN CONTROLLED SUBSTANCES SCHEDULE I, THE RATE OF INTRODUCTION OF NEW FENTANYL ANALOGS INTO THE UNITED STATES DROPPED DRAMATICALLY.

POINT OUT THAT THE US HAS BEEN ABLE TO PERSUADE CHINA TO MOVE FENTANYL ANALOGS INTO THEIR EQUIVALENT OF SCHEDULE I, AND WE MUST DO THE SAME IN THE U.S.!

POINT OUT THAT ALL 50 STATE ATTORNEYS GENERAL AS WELL AS THE ATTORNEYS GENERAL OF WASHINGTON, D.C. AND PUERTO RICO UNANIMOUSLY SENT A LETTER TO CONGRESS REQUESTING PASSAGE OF THE SOFA ACT.

POINT OUT THAT THE TEMPORARY PLACEMENT OF FENTANYL ANALOGS IN SCHEDULE I WILL EXPIRE FEBRUARY 6TH UNLESS THE SOFA ACT IS PASSED BEFORE THEN.

Background:

The SOFA Act amends the Controlled Substances Act to add illicit fentanyl analogs to Schedule I.

Schedule I controlled substances have a high potential for abuse and no currently accepted medical value.  They are subject to strict regulatory controls and penalties under the Controlled Substances Act.

              Fentanyl analogs are a group of drugs that share the fentanyl backbone and act at the same receptors as fentanyl. They have minor surface tweaks which make them legally distinct compounds. Federal officials attempting to fight the opioid epidemic were faced with having to go through a lengthy process to get each legally distinct analog moved into Schedule I, and during the lengthy process, new fentanyl analogs were being introduced. 

In February 2018, the Drug Enforcement Administration invoked emergency powers to temporarily move all illicit fentanyl analogs into Schedule I.  The result of this action was that the pipeline of new fentanyl analogs shut down.

But this ban expires February 6th, and we may expect a rapid resumption of widespread distribution of fentanyl analogs shortly after the expiration. 

The SOFA Act was designed to amend the Controlled Substances Act to permanently add illicit fentanyl analogs to Schedule I.

At this point, the only major resistance to the SOFA Act is coming from civil liberties groups.  They argue that drug use and addiction are primarily public-health matters that need treatment rather than criminal sanctions.  They argue that passage of the SOFA Act would grant the DEA the power to impose harsh mandatory minimum sentences for possession of an analog.

We obviously agree that drug abuse and addiction need treatment, not harsh criminal penalties. But the SOFA Act is aimed at those who are distributing death throughout our country, not at the individual suffering from a substance use disorder.  And it is simply wrong-headed to prevent law enforcement from using the SOFA act to pursue those who are selling deadly fentanyl analogs to men and women suffering from opioid use disorder.

In 2017, 40% of opioid overdose deaths in Florida were due to fentanyl analogs.  We need to do whatever can be done to stop fentanyl analog death.

We need the SOFA Act.

STOPPING OVERDOSES of FENTANYL ANALOGUES (SOFA) ACT

This bill amends the Controlled Substances Act to add certain fentanyl analogues to schedule I. A schedule I controlled substance is a drug, substance, or chemical that: has a high potential for abuse; has no currently accepted medical value; and is subject to regulatory controls and administrative, civil, and criminal penalties under the Controlled Substances Act. Please, contact your senator and congressperson, and implore them to support the SOFA Act, and why they must pass the legislation ASAP!! 

Submit your comments to the FDA

The FDA is looking into how naloxone can be made more available.  They’ll be having an Advisory Committee meeting on December 17th and 18th to discuss this matter.

The FED UP! Coalition has long advocated for ready access to naloxone. Too many people have died because they did not have naloxone readily available.

The FED UP! Coalition plans to communicate to the FDA:

  1. All forms of naloxone should be sold over the counter
  2. The Federal government should subsidize over the counter naloxone to keep the price under $20 per dose.
  3. The Federal government should launch a public awareness campaign regarding Naloxone to cover such issues as:
    • Should you have naloxone in your home or place of business?
    • How do you know when to administer naloxone?
    • How do you administer naloxone?

The FDA is also asking what has worked in your community to expand naloxone access and in what circumstances you believe that naloxone should automatically be prescribed when an opioid is prescribed.  You may want to let them know your opinion on these issues as well.

Comments sent by Friday, Dec. 14, 2018, will be reviewed by the FDA Advisory Committee.