Pharma Firm That Owes Millions in Opioid Settlement Wants in on Lucrative Anti-Overdose Drug Contract

The New York State Department of Health is opening up its exclusive contract for naloxone next year to other companies that make the drug — potentially including one on the hook for tens of millions of dollars in an opioid settlement.

Hikma Pharmaceuticals, which is set to pay $150 million in settlement funding to six states including New York for their role in fueling the opioid crisis, is trying to get in on the contract.

The firm has been persistently marketing their version of naloxone to the state health department, specifically its AIDS Institute , which is tasked with making decisions about the contract.

If Hikma succeeds, that would mean some of the money they’re paying the state into a fund meant for community relief would go right back into their pockets.

Kloxxado, Hikma’s version of nasal naloxone, comes only in an 8 mg version — twice the dose of Narcan. Studies have shown that higher dosages lead to more complications, without boosting the drug’s efficacy in reversing overdoses.

“They are trying to make a buck off of the epidemic they created,” said Alexis Pleus, executive director of Truthpharm, an advocacy group dedicated to reducing the harms of substance use in New York. “And they are doing this with a much worse product.”

A coalition of attorneys general from a dozen states alleged that from 2006 to 2021, Hikma, which makes a range of generic opioids, had “failed to monitor and report suspicious opioid orders from potentially illegal distributors, even while its personnel knew their systems to monitor suspicious orders were inadequate and prone to failure.”

Over the past year, representatives of the company have been pitching their naloxone product in multiple meetings with health officials, and lobbyists have matched the effort with heavy attention to the department, according to those familiar with the process and lobbyist filings reviewed by THE CITY.

A source with first-hand knowledge of meetings between the AIDS Institute and Hikma told THE CITY that the company has forcefully argued that their 8 mg version is necessary to deal with the more potent drug supply present because of fentanyl. Hikma has even brought parents who lost children to fentanyl overdoses to talk to state officials.

Hikma’s pitch to state officials matches the company’s public facing marketing that “there’s no time for half measures,” a reference to Narcan’s 4 mg option.

“They are trying to make it seem like their medication is necessary so they can make a buck,” said Pleus. “They are doing a lot of fear-mongering about fentanyl, but their drug does not change survival odds.”

“Those on the frontlines of this public health epidemic need all FDA-approved treatment options available to them, which is why we provide 8 mg nasal Kloxxado and generic injectable naloxone options to help meet the urgent needs of patients and communities across New York and the nation as a whole,” said Hikma spokesperson Steven Weiss in a statement to THE CITY.

Weiss explained that Hikma remains committed to expanding access to Kloxxado and has donated over 375,000 doses to health care providers and first responders.

Opioid settlement funding — money secured from lawsuits against companies responsible for the manufacturing and distribution of opioids — is frequently used to purchase naloxone. And Hikma is not the only pharmaceutical company trying to cash in on settlement funds they owe or have paid into.

Teva, set to pay New York millions in settlement funding for propagating false information about the dangers of opioids, also makes a 4 mg version of naloxone included in the state’s standing order to provide discounted naloxone to the public at pharmacies.

Intense Withdrawal Symptoms

The state health department is currently divided about whether to open the contract up to all companies, including those that manufacture what is widely considered in the department to be a substandard product, according to a source familiar with the department’s process.

In a systematic review of naloxone administration in emergency departments, experts determined that higher doses of naloxone increase the risk of precipitated withdrawal , when the use of an addiction medication causes withdrawal symptoms like vomiting, nausea and even seizures in extreme circumstances.

“It can be incredibly violent for someone to be revived with that much,” said Steven Hernandez of St. Ann’s Corner of Harm Reduction in The Bronx, who also explained that going into precipitated withdrawal can even cause someone to try to use more opioids to manage the intense symptoms. “The higher dose takes humanity out of the equation.”

New York conducted its own comparison of 8 mg and 4 mg naloxone last year, providing state police with one or the other. The study found that the medications were equally effective at reviving overdosing individuals, but the 8 mg dose sent nearly double the number of people into intense withdrawal symptoms. More individuals were transported to the hospital after the use of 8 mg naloxone as well.

“The pharmaceutical company just sees dollar signs,” said John Barry of the nonprofit New York State Harm Reduction Association. “They do not care about what happens to the people using.”

Lobbying New York State

Hikma focused much of their lobbying efforts last year towards an Assembly bill that would require the health department make all FDA-approved versions of approved opioid reversal agents available for contracts and in the state’s standing order.

If the bill became law, Hikma’s Kloxxado would be guaranteed a spot in state contracts. The bill has passed through the Assembly, and a version is now in committee in the state Senate.

Senator Pete Harckham (D-South Salem) and Assemblyman Phil Steck (D-Colonie), who introduced the bills , have been lobbied by Hikma alongside other co-sponsors listed on the bills, filings reviewed by THE CITY show.

“All medications should be available for contract,” Steck told THE CITY. “I have not taken a look at the different medications because I am not the FDA.”

Harckham pointed to the dire status of the opioid epidemic in New York as a reason to expand access. “We should be fighting it with every tool available and every FDA authorized reversal agent should be on the table,” he said. “I will continue to work on clearing the way for greater access to overdose reversal agents in the coming year.”

Many that oppose the state’s current single-source contract with Emergent BioSolutions, the makers of Narcan, suggest that an open and competitive bidding process will allow for the state to sign contracts at the lowest prices.

While a spokesperson said the state Department of Health is set to explore other naloxone options for next year, at the end of July it will renew for one year its contract with Emergent, to whom it pays over $10 million dollars annually.

The state also defended the long-standing contract with Emergent in its statement to THE CITY. “Narcan is currently the most effective and affordable brand of naloxone that comes in FDA-preferred dosage levels,” said DOH spokesperson Cadence Acquavia.

‘Biggest Gun’

Advocates for and against the incorporation of higher dose naloxone into the contracting process both point to law enforcement as the loudest proponent of an 8 mg option.

“They want the biggest gun in the holster,” Barry said. “Even if it is not a better weapon against overdose.”

Calls for the state to open to all manufacturers of naloxone have also been raised by some in the field of addiction care, including in a March opinion piece in the Times Union that called for the state to contract for higher doses.

The sentiment was echoed in a Thursday opinion piece by Robert Kent, former general counsel for the state’s Office of Addiction Services and Support, a department that also contracts for over $4 million annually with the makers of Narcan.

Kent told THE CITY that having all options, including the 8 mg option, is worth a company paying settlement funds like Hikma profiting off of an addiction treatment mediation.

“There should be a competitive process so there can be multiple products contracted at the lowest prices,” Kent said. “Frontline workers like law enforcement should be able to be equipped with all dosages and then assess what is needed.”

But for many working in the field, they would rather the health department go with what they view as the “tried and true” options of 4 mg naloxone.

“Law enforcement are not the experts on substance use,” said Barry of New York State Harm Reduction Association, “and this will unwittingly do a lot of damage.”

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