35 States Sue Suboxone Drugmaker for Conspiracy

35 States Sue Suboxone Drugmaker for Conspiracy

Thirty-five states and the District of Columbia have filed an antitrust lawsuit alleging that two pharmaceutical Suboxone Drugmaker companies have conspired to keep a cheaper generic version of Suboxone off the market. The lawsuit claims that British drugmaker Indivior, along with a New Jersey company that makes dissolvable oral drug strips, conspired to corner the market on the brand-name medication Suboxone, which is widely used to treat people dependent on heroin and other opioids. Suboxone is a trademarked compound of buprenorphine and naloxone. Buprenorphine is an opioid partial agonist, which helps relieve symptoms of opiate withdrawal. Naloxone, well known by the brand name Narcan, is used to reverse the deadly effects of an opioid overdose. According to the lawsuit, Indivior was granted exclusive rights in 2002 to sell Suboxone brand tablets for seven years. When the seven years were up, the suit says, the company enjoined MonoSol RX, the NJ dissolvable strip maker, to develop an oral-strip form of Suboxone. Indivior then marketed the dissolvable oral Suboxone strips as a trademarked product, says the lawsuit, claiming it was safer than tablets. The state attorneys say that this practice is called "product hopping" - making small changes to a product to keep cheaper alternatives off the market - and it's illegal. "When prescription drug companies unlawfully manipulate the marketplace to maximize profits, they put lives at risk and drive up the cost of healthcare for everyone," said California Attorney General Kamala Harris.

Conflicting testimony in the House

Meanwhile in Washington, witnesses at a House subcommittee hearing gave conflicting answers to questions about the fairness and workability of the opioid painkiller market. On one hand, the vice president for policy and research for the Pharmaceutical Research and Manufacturers of America (PhRMA), a pharmaceutical industry trade group, said there's "robust competition" in the opioid painkiller marketplace. "When you look at the pipeline we have 31 abuse deterrent formulations in development for the treatment of pain," Ann McDonald Pritchett said. "There are 35 addiction medicines in development, and 49 opioid pain medications in development potentially providing important treatment alternatives to what's currently on the market." On the other hand, other presenters disagreed, and one referred obliquely to the actions covered by the states' Indivior suit. Robin Feldman, JD, director of the Institute for Innovation Law at the University of California, told the subcommittee that although open competition is the backbone of US markets, "we're not seeing that in the market for addiction medicine." Instead, she said, drug companies are "playing regulatory games, stringing these out one after another while competition languishes on the sidelines." "These games come in two baskets. One involves manipulating Hatch-Waxman - the system for quick approval of generic drugs when the patent on the main drug expires. The other basket relates to the system for non-patent exclusivity. "We've seen petitions asking the FDA to deny approval of any generic version. One addiction medicine company asked the FDA to require things for generic Suboxone that it didn't have the authority to do," she said, possibly referring to Indivior without naming the company. "The agency denies 80% of these petitions - as it denied this one - but the process takes time, even for silly petitions," she added.

Medicines are too costly to be widely available

Eric Ketcham, MD, immediate past president of the New Mexico chapter of the American College of Emergency Physicians, told the subcommittee that there are definitely cost and availability problems with both generic buprenorphine and naloxone, and these costs are also being reflected in the cost of Suboxone. "One would think that life-saving and life-transforming medications such as buprenorphine would be accessible to hundreds of thousands of opioid dependent patients. Unfortunately that's not the case," he said. "For example, based on surveys I've conducted with local pharmacies, the cost for a 30 day supply of buprenorphine is $334, compared with just $142 just six months ago. And a month of Suboxone filmstrips was $532. Shockingly the generic version of the combination tablets is even more than the brand-name filmstrips and costs $625 for a 30 day supply." Ketcham added that the cost of a 1 mL syringe of naloxone rose from $12 in 2012 to $30 in 2016. "The consequence of these rising prices may force naloxone out of the budget for rural fire or EMS services that don't have the buying power of a hospital or a larger municipal agency."

Using REMS to block generics

David Gaugh, senior vice president for sciences and regulatory affairs at the Generic Pharmaceutical Association, told the subcommittee that generic drugmakers face "significant delay tactics from brand manufacturers." By preventing generic competition they are definitely causing problems in the market for treatments for opioid abuse, he said, and this includes manipulating the FDA's Risk Evaluation and Mitigation Strategies (REMS) that control how some opioids can be distributed to doctors and patients. "While current law forbids brand-name companies from using REMS to delay competition," Gaugh said, "they are nonetheless denying generic manufacturers access to samples of their products." He suggested that some companies are even applying restricted access programs to drugs for which the FDA doesn't require REMS, in order to force delays of generic drugs entering the marketplace. According to a report in MedPage Today, subcommittee members appeared to agree that competition in this marketplace is a real problem. "We have to pay particular attention to this and react, because it's only going to get worse," said subcommittee chairman Tom Marino (R-Pa).

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