It’s been less than two weeks since the US Department of Justice joined a string of lawsuits against Indivior—the maker of the drug Suboxone, which is used to treat opioid use disorder— alleging the company engaged in a fraudulent patent-hopping scheme designed to prevent cheaper generic versions of the drug (a combination of buprenorphine and naloxone) from hitting market. Now the Food and Drug Administration has set the stage for yet another legal battle over lifesaving medication—and if history is a guide, profits are likely to be prioritized over people.
On April 19 the FDA approved the first generic version of the opioid overdose antidote naloxone hydrochloride, delivered in a nasal spray. This gives pharmaceutical giant Teva the green light to market its own version of the delivery device first developed by ADAPT Pharma—which was acquired last August by Emergent BioSolutions for $735 million.
The FDA touted its decision on Teva as a game-changer that will increase access to a much-needed resource in the fight against fatal opioid overdose. “In the wake of the opioid crisis, a number of efforts are underway to make this emergency overdose reversal treatment more readily available and more accessible,” the agency said in a press statement. “Today’s approval is the first generic naloxone nasal spray for use in a community setting by individuals.”
If Teva wins the case and begins producing its own version, we shouldn’t assume a happy outcome.
But analysts say it could be some time before the drug hits market. That’s because Emergent BioSolutions is locked in a patent lawsuit with Teva over the new formulation, with a trial expected to begin later this year.
And if Teva wins the case and begins producing its own version, we shouldn’t assume a happy outcome. Teva was recently named as one of more than a dozen pharmaceutical companies accused of colluding to artificially elevate drug prices—part of what Joseph Nielsen, an assistant attorney general and antitrust investigator in Connecticut, called “most likely the largest cartel in the history of the United States.”
Against this backdrop, not a day goes by without another news story maligning Purdue Pharma and other drug companies for what many view as their deliberate efforts to hook the American populace on dangerous addictive drugs. On April 23 the federal government took the unprecedented step of filing drug trafficking charges against pharmaceutical distributor Rochester Drug Cooperative and its former CEO. The indictment marks the first set of criminal charges filed against a drug company for its role in the overdose crisis, which claimed over 70,000 lives in 2017 alone.
But having reported extensively on Indivior’s insidious scheme to kill generic Suboxone before its patent even ran out, so it could continue to reap millions from rising demand for its addiction treatment drug, the real scandal, it seems to me, isn’t about what drug a company makes.
Rather, it’s the impunity with which Big Pharma games the system, using dubious marketing techniques and complex patent law to maximize profits at the cost of human lives. Regulatory authorities are not doing nearly enough.
For instance, Suboxone, which is far more expensive than some other buprenorphine formulations (you can see a full price list here), was cobbled together from two off-patent drugs: buprenorphine and naloxone.
Naloxone was ostensibly included to prevent diversion and misuse by negating the opioid effect. But the misuse potential of buprenorphine is already low, and addiction doctors tell me that the addition of naloxone to the formulation does little to change that—besides jack up the price thanks to patent protection. Alison Knopf’s reporting for Filter has similarly cast doubt on the medical justifications for adding naloxone.
As Filter has also reported, PReP medications to prevent HIV have been price-gouged, too—despite the CDC itself holding a patent to Gilead’s drug Truvada.
Fixing a Problem That Needn’t Exist
Naloxone, as a standalone overdose reversal drug, has itself been the subject of industry sleight of hand.
The medication was first patented in 1961, and was approved for use in the reversal of opioid overdoses 10 years later. But for decades it was only carried by emergency medical professionals and available for intramuscular or intravenous injection. Since its introduction, the price of the drug has risen by 4,000 percent—even as more manufacturers have entered the market.
“We’re not talking about a limited commodity,” the late harm reduction advocate Dan Bigg, who died last year at the age of 59 of a drug overdose, once told reporters. “Naloxone is a medicine that is almost as cheap as sterile sodium chloride—salt water.”
The patenting and introduction of new delivery systems is partly to blame for the exponential rise in the naloxone’s price.
ADAPT’s intranasal naloxone, Narcan, was developed in 2014 and released two years later. In marketing materials it is described as “the first and only FDA-approved naloxone nasal spray developed for use in a community setting.” Since then, the small plastic atomizer, which delivers a 4mg dose of naloxone with the push of a button, has become so ubiquitous that many people are unaware that other formulations even exist.
The good news is that regulators, for all their shortcomings, don’t seem to be relying solely on Pharma to contain the overdose crisis.
Yet, as of January 2017, there were 11 FDA-approved naloxone products manufactured by six different companies. Only one was not recommended for layperson and take-home use, according to the group Prescribe to Prevent. The cheapest of these options sell for a fraction of the price of intranasal naloxone and are favored by many harm reduction groups.
The good news is that regulators, for all their shortcomings, don’t seem to be relying solely on the pharmaceutical industry to contain the overdose crisis. On the day it approved Teva’s generic naloxone, the FDA also said it will prioritize its review of generic drug applications for naloxone, consider regulations allowing for the co-prescribing of naloxone, and possibly open a pathway to the sale of naloxone over the counter—something for which advocates have long been fighting.
Reporting from the streets of Philly, I’ve seen far more overdose reversals conducted by drug users and other community members than by first responders. Generic naloxone nasal spray is a welcome addition to the overdose-reversal product field. But with cheaper injectable alternatives already available, it’s fixing a problem that shouldn’t exist in the first place.