A major drug maker engaged in anticompetitive behaviors that limited patients' access to the leading treatment for opioid use disorder, blocking generic competitors in order to maintain high prices and generate substantial profit, according to a perspective published Wednesday in the New England Journal of Medicine.
The revelation comes as the nation is struggling to stem the rate of opioid overdoses and save lives amid a ballooning public health crisis. By keeping the price of Suboxone® — a leading buprenorphine treatment used to manage opioid use disorder — artificially high due to a lack of competition, drug manufacturer Reckitt Benckiser (now Indivior) profited substantially and cost federal programs hundreds of millions of dollars, according to the researchers’ analyses.
“In the grips of the opioid crisis, which claims the lives of tens of thousands of people every year in overdoses — and affects millions more living with the addiction — a highly effective medication to treat opioid addiction has been out of reach for many due in part to its high price,” said Richard Frank, Professor of Health Economics at Harvard Medical School and a study author. “Our findings show that Suboxone’s manufacturer was able to maintain the drug’s expensive price tag by engaging in a number of different anticompetitive practices to maintain product exclusivity. These practices are widely used across the pharmaceutical industry and require regulatory reform.”
Frank co-authored the perspective, which was funded by Arnold Ventures, with Rebecca L. Haffajee, Policy Researcher at the RAND Corporation and Adjunct Assistant Professor at the University of Michigan.
In 2017, 47,600 Americans died from an opioid-related overdose. Medications used to treat opioid use disorder have been shown to significantly reduce the risk of overdose, yet only a small fraction of people receive evidence-based treatment. The high price tag limits the volume of drugs that can be purchased, especially for public payers like Medicaid, a leading purchaser of Suboxone.
Even after the patent on the drug’s key ingredient expired, the manufacturer exploited regulatory procedures and other patent policies to deter generic competition and maintain high prices, including so-called “product hops” — launching a reformulation of a brand name drug with additional or new benefits to insulate the brand from generic competition — filing questionable citizen petitions, abusing the Risk Evaluation and Mitigation System (REMs), and generating patent thickets.
The delays to generic entry resulted in at least $1 billion in extra profits to the manufacturer, the study found.
“These tactics to extend market exclusivity are alarming and are not limited to this one company, which underscores the necessity for reform,” said Haffajee. “Our findings show that when a single regulatory loophole is closed, pharmaceutical companies find other avenues to exploit, which is why comprehensive regulations like the recently passed CREATES Act are so necessary to end anti-competitive behaviors like this once and for all.”