By Jody Coultas, J.D.
The FTC had alleged that Reckitt violated the antitrust laws through a scheme to maintain its dominance in the market for prescription drugs that treat opioid addiction.
Reckitt Benckiser Group plc has settled FTC charges that it allegedly conspired to prevent lower-priced generic competition to its branded drug Suboxone from entering the market through an illegal "product-hopping" scheme, the FTC announced (FTC v. Reckitt Benckiser Group PLC, FTC File No. 131 0036, Civil Action No. 1:19CV00028).
Suboxone, a prescription oral medication used to minimize withdrawal symptoms in patients recovering from opioid addiction, was introduced in 2002. In 2009, when Reckitt’s regulatory exclusivity for Suboxone was set to expire, Reckitt and its former subsidiary Reckitt Benckiser Pharmaceuticals, now known as Indivior, Inc., developed a dissolvable oral film version of Suboxone and worked to shift prescriptions to this patent-protected film. Believing that consumers may not want to switch to the new product, Reckitt allegedly employed a "product hopping" scheme where the company misrepresented that the film version of Suboxone was safer than Suboxone tablets because children are less likely to be accidentally exposed to the film product. Also, Reckitt, through Indivior, filed a citizen petition with the FDA reciting the same unsupported safety claims and requesting that the agency reject any generic tablet application in order to delay the approval of generic competitors while the FDA reviewed it.
A proposed stipulated order requires Reckitt to pay $50 million and bars the company from similar future conduct. 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. Also, Reckitt is required to leave a 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 any time a generic companies file for FDA approval of competing versions. Finally, the order 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.
Government claims. In 2014, the FTC’s investigation of Reckitt’s conduct was largely put on hold due to a parallel federal criminal investigation for related conduct that ultimately resulted in a 28-count indictment of Indivior. The settlement does not resolve any claims against Indivior.
The proposed FTC settlement is also part of a broader government settlement with Reckitt, which resolves criminal and civil fraud claims by the U.S. Attorney’s Office for the Western District of Virginia and Department of Justice.
Private suits. Direct and indirect purchasers of Suboxone, including a group of 35 states and the District of Columbia, are currently proceeding with a similar suit against Indivior and specialty pharmaceutical company MonoSol Rx, LLC, alleging that the companies conspired to delay the entry of competitors to Suboxone through illegal product hopping (In re Suboxone Antitrust Litigation, MDL No. 2445, 13-MD-2445).
Companies: Reckitt Benckiser Group plc; Indivior, Inc.
MainStory: TopStory Antitrust FederalTradeCommissionNews
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