US senator is urging the US Federal Trade Commission to accelerate its antitrust investigation into a drug maker that sells Suboxone, a medicine used to treat addiction to opioids and narcotics.
The appeal by Senator Edward Markey (D-Mass.) comes less than a week after 35 states filed an antitrust lawsuit against Indivior, accusing the company of engaging in a scheme to block generic competition. In doing so, the company “drove up prices and deprived states and consumers of lower costs,” Markey wrote in his letter on Tuesday to FTC chairwoman Edith Ramirez.
The moves are the latest in a long-running saga surrounding Suboxone.
The drug, which combines buprenorphine and naloxone, was first approved by the US Food and Drug Administration in 2002. At the time, Suboxone was sold by Reckitt Benckiser, which later spun off its pharmaceutical business as Indivior. At the time, the company was granted exclusive rights for seven years to sell the pill in order to recoup its investment, since the patient population was deemed small.
However, as the exclusivity neared an end, the tale took an interesting turn. Reckitt began selling a dissolvable film strip, which the FDA actually believed posed a greater risk to children. And in 2012, Reckitt pulled its older pill version from the market, claiming it posed a danger to children, and then petitioned the FDA to delay approval of generic versions.
These moves prompted the FDA to refer the matter to the FTC for investigation, a probe that has lingered ever since. By 2013, the FDA approved two generic versions of the older Suboxone pill, but as Markey noted, there are no lower-cost generic versions of the Suboxone film strip, which Indivior developed with the help of MonoSol. The lawsuit filed by the states names this company as well.
In announcing that lawsuit last week, California Attorney General Kamala Harris also noted that Reckitt raised the price of its pill while lowering the price of the newer film version. And the patent on the new version does not expire until 2023. This is a pharmaceutical industry tactic known as forced switching, since patients and physicians have little choice but to consider a newer, higher-priced version.
In his letter to the FTC, Markey also pointed out that the manufacturer has “significantly impeded the FTC investigation by attempting to deny the FTC access to thousands of pages of documents that are integral to the investigation.” However, he also noted that the federal court overseeing the matter later ordered the company to produce the documents.
So will the FTC step on the gas? We asked the FTC for comment and will update you accordingly, although normally the agency merely acknowledges receipt of a letter in such situations. We also asked Indivior for comment and will pass along any reply.