Recently, Indivior, Inc. agreed to pay $10 million to settle allegations by Federal Trade Commission (FTC) that it violated antitrust laws through a deceptive scheme to thwart lower-priced generic drug competition with its branded opioid replacement therapy drug, Suboxone.
According to FTC’s complaint against Indivior, Suboxone became an integral part of opioid addiction treatment shortly after its 2002 introduction. In 2009, Indivior’s regulatory exclusivity for Suboxone was set to expire and the company anticipated steep competition from lower-cost generic drugs. Because of that anticipation, the FTC alleges, before the generic versions of Suboxone tables became available, Indivior developed a dissolvable oral film version of the drug and worked to shift patient prescriptions to the patent-protected film instead of the former tablets. Indivior promoted the Film by using false and misleading claims that the Film was less susceptible to accidental children exposure than the Tablets.
Additionally, the FTC also alleged that Indivior filed a meritless petition with the United States Food and Drug Administration (FDA) citing unsupported claims that the Tablets had been discontinued due to safety concerns about the tablet formulation of the drug and requesting that the agency reject all generic Suboxone tablet applications.
As part of the settlement, Indivior has restrictions placed on its ability to participate in the Citizen Petition Process. If Indivior files a Citizen Petition, it shall disclose to the FDA and FTC the studies and data on which the Citizen Petition relies and all studies and data within the knowledge/possession of Indivior that address the validity or strength of one or more of the material contentions in the Petition.
The agreement also requires Indivior to notify the FTC within thirty days of starting to market – directly or through a licensee – drug products in the United States. This includes receiving FDA approval to market a drug product in the United States, acquiring control of a person that has FDA approval to market a drug product in the United States, or acquiring or licensing a drug product that – at the time of the acquisition – has FDA approval to be marketed in the United States.
Indivior is also required to submit annual reports to the FTC for 10 years (the first report is due within 60 days after the Order is entered), outlining the manner and form in which the company has complied, and continues to comply, with the Order.
Reckitt Benckiser Settlement
This settlement follows the July 2019 FTC settlement with Indivior’s former parent company, Reckitt Benckiser Group plc. That case involved the same allegations levied by the FTC against Indivior, and resulted in a $50 million settlement.
The settlement and Order also bars Reckitt from engaging in any future similar conduct and includes similar restrictions to the Indivior settlement. For example, if Reckitt introduces a reformulated version of an existing product, it must provide the FTC with information about that product and the reasons for its introduction. If generic companies file for FDA approval of competing versions of the branded drug, the order requires Reckitt to leave the original product on the market on reasonable terms for a limited period so that doctors and patients can choose which formulation of the drug they prefer. The order also requires that if Reckitt files a citizen petition, the company must simultaneously submit any data or information underlying that petition to the FDA and FTC.
The FTC settlement with Reckitt was part of a broader government settlement which resolved criminal and civil fraud claims by the United States Attorney’s Office for the Western District of Virginia and Department of Justice.
Suboxone Settlements
Money from both of the settlements will be combined into a fund that will be used to provide payments to people who previously purchased the Suboxone Oral Film. Those who were prescribed Suboxone film from March 1, 2013 through February 28, 2019, and who wish to file a claim for part of the settlement money can do so by visiting www.ftc.gov/suboxone.
This stipulated final order will become final and have the force of law once signed and entered by a District Court judge.