Markey Calls on FTC to Fully Investigate Suboxone Drugmaker for Antitrust Violations

Life-saving drug is one of only three approved medications for opioid use disorders

Washington (September 27, 2016) – With 78 Americans losing their lives everyday due to prescription painkiller and opioid overdoses, Senator Edward J. Markey (D-Mass.) today called on the Federal Trade Commission (FTC) to investigate Indivior, the manufacturer of the drug Suboxone, for antitrust violations. Suboxone combines buprenorphine, an opioid used to treat addiction to heroin and prescription painkillers, with naloxone, which can cause intense withdrawal symptoms and is intended to prevent abuse. In 2002, the Food and Drug Administration granted Indivior exclusive rights to sell and market Suboxone. But when this exclusivity neared and the possibility of cheaper generic competition arose, the company pulled its pill formulation of Suboxone, claiming it was potentially dangerous to children, and replaced it with a more expensive oral film strip, whose patent does not expire until 2023. Recently, 35 states and the District of Columbia filed a lawsuit against Indivior alleging that the company violated antitrust laws by conspiring to block generic competition, extending its monopoly.

“In light of the potential impact Indivior’s actions delaying approval of cheaper generic competition have had on federal spending under both Medicare and Medicaid, and the impact on consumers, I respectfully request that the FTC accelerate its investigation to determine whether Indivior engaged in unlawful and anti-competitive behavior and to take any necessary enforcement actions,” writes Senator Markey in the letter to FTC Chairwoman Edith Ramirez. “It is now more important than ever that the FTC vigilantly investigate allegations that pharmaceutical companies have thwarted competition, unlawfully increased profits, or illegally extended monopolies in connection with medication-assisted treatments for opioid use disorders.”

A copy of Senator Markey’s letter to the FTC can be found HERE.

In July, President Obama signed into law the Comprehensive Addiction and Recovery Act (CARA). The law include a provision that mirrors a proposal in The Recovery Enhancement for Addiction Treatment (TREAT) Act, legislation originally introduced by Senators Markey and Rand Paul (R-Ky.). For the first time, trained nurse practitioners and physician assistants will be able to provide life-saving medication-assisted therapies such as buprenorphine (also called Suboxone).