Indivior: A Safety Pitch With a Price to Protect

The Indivior Suboxone civil settlement was a $300 million agreement over allegations that the company’s safety and marketing representations caused false claims for government payment. The drug treated opioid addiction. The commercial story involved what doctors heard about its safety, what public programs paid for it and whether cheaper competitors could reach the market.

The Justice Department announced the civil settlement on July 24, 2020. This pharmaceutical fraud case followed a separate agreement with Reckitt Benckiser Group, Indivior’s former parent. The earlier agreement gives a detailed account of the alleged sales practices behind the Suboxone business: selling the film as safer, promoting prescriptions without the supporting care and invoking safety concerns to delay generic competition.

The Civil Settlement and the Companies Behind Suboxone

The Indivior civil agreement resolved claims in six False Claims Act qui tam lawsuits brought by whistleblowers in federal courts in the Western District of Virginia and the District of New Jersey. The government had already joined the three Virginia cases. The settlement resolved allegations that, from 2010 through 2015, Indivior companies knowingly promoted Suboxone to physicians writing prescriptions that lacked a legitimate medical purpose or any counseling or psychosocial support, promoted Suboxone Film to physicians and state Medicaid agencies with false and misleading claims that it was less susceptible to diversion and abuse than other buprenorphine products and to accidental pediatric exposure than tablets, and used the September 25, 2012, tablet petition and other steps to delay generic competition and control Suboxone pricing. Of the $300 million, about $209.3 million was for the federal government and $90.7 million for the states choosing to join the agreement. The whistleblowers’ share had not been determined when the settlement was announced.

Indivior Inc. previously operated as Reckitt Benckiser Pharmaceuticals Inc., a wholly owned Reckitt subsidiary that marketed and sold Suboxone in the United States. Reckitt spun it off in December 2014. That separation explains why the former parent and Indivior appear in different settlement announcements over the same drug.

The allegations concern a manufacturer’s influence over prescriptions and payment. A manufacturer can cause a false claim through the promotion that produces the prescription, even when another business submits the bill. That is why the safety message matters beyond the sales call: it can reach the public program through a decision made by someone else. Indivior also signed a five-year corporate integrity agreement with the Office of Inspector General of the Department of Health and Human Services. Each year its top executives and board must certify compliance and the company must conduct risk assessments and other monitoring, while an independent review organization conducts audits.

The Safety Claims Behind the Prescriptions

The government alleged that Suboxone Film’s comparative safety was a selling point aimed at both physicians and state Medicaid agencies. In the Reckitt civil settlement’s account of conduct from 2010 through 2014, the Justice Department alleged that Reckitt promoted the film with false and misleading claims about diversion, abuse and accidental exposure in children.

The comparisons were specific. The film was allegedly promoted as less susceptible to diversion and abuse than other buprenorphine products, and less susceptible to accidental pediatric exposure than tablets. Each comparison gave a different audience a reason to favor the film. A physician choosing a treatment and a Medicaid agency deciding how to cover it were hearing claims about the same product.

The pitch was about protecting children. The government alleged a strategy that also protected the price.

For someone in medical affairs or market access, the useful comparison is the evidence behind each safety claim and the message that reached the customer. We examine what the underlying information supported, how the company described it and which prescribing or coverage decision the message was meant to influence. A presentation’s choice of comparator can matter as much as its headline.

Prescriptions Without the Supporting Care

The earlier civil settlement also addressed allegations that Reckitt promoted Suboxone to physicians writing prescriptions without counseling or psychosocial support. The government alleged promotion for unsafe, ineffective and medically unnecessary uses, with prescriptions often diverted to uses lacking a legitimate medical purpose.

Suboxone’s approved purpose was to help people undergoing treatment avoid or reduce opioid withdrawal symptoms. In that setting, the alleged absence of supporting care goes to what the patient actually received. The sale generated a prescription for a treatment drug, while the government questioned the medical purpose and circumstances of the use being promoted.

For an insider, the prescriber relationship is part of the story. We look at the uses a company encouraged, the information it had about those uses and how its promotional decisions connected to prescriptions paid by the government. Sales knowledge and clinical knowledge may sit in different parts of the business, but the prescription brings them together.

The Tablet Withdrawal and Generic Competition

The government alleged that a safety explanation also served a commercial purpose in withdrawing Suboxone tablets. The Reckitt civil settlement described a petition submitted to the Food and Drug Administration on September 25, 2012, claiming that the tablets had been discontinued because of safety concerns. It alleged that the petition and other steps delayed generic competition to control Suboxone pricing, including prices paid by federal healthcare programs.

That allegation joins the sales message to the product strategy. The film was promoted as having safety advantages, while the tablet’s withdrawal was presented as a response to safety concerns. According to the government’s civil account, the same business stood to benefit from keeping generic competitors out.

The economics of switching patients to a different formulation explain why tablets and film matter. A generic application matches the reference drug’s active ingredient, strength, dosage form and route, and shows that it works equivalently in the body. Approval as a generic tablet does not make that product a substitute for a film. The formulation on the prescription matters to the competition that can fill it.

The manufacturer therefore sells more than an active ingredient. It sells a particular approved product, and moving prescriptions to another presentation can change which competitors can replace it at the pharmacy. That is the commercial reason to read a withdrawal plan alongside the launch plan for the replacement.

Medicaid coverage adds another decision. State programs can use formularies and require prior authorization for covered outpatient drugs. A safety claim directed at the program can therefore matter to access as well as to a doctor’s choice. Comparing the manufacturer’s medical message with its coverage submissions helps connect those decisions without losing the product or the payer along the way.

Reckitt’s Separate Suboxone Settlement

Reckitt agreed to a $700 million civil settlement, announced on July 11, 2019, over allegations that Suboxone marketing caused false claims to government health care programs.

The former parent also reached a separate agreement with the Federal Trade Commission over alleged efforts to impede generic Suboxone competition. Under that agreement, if Reckitt filed a citizen petition about a drug, it had to disclose all relevant studies and data to both the Food and Drug Administration and the Federal Trade Commission at the same time. It also agreed not to withdraw or disadvantage a drug after obtaining approval for another containing the same active ingredient. Indivior accepted the same two commitments in its own consent decree with the Federal Trade Commission and paid $10 million to resolve claims that it used unfair methods of competition to impede generic equivalents of Suboxone.

What Evidence Is Needed to Prove Fraud?

In a promotion case like Suboxone, the evidence connects the company’s message, what it knew, the prescription or coverage decision and the government payment. Our work with an insider follows those connections through the business.

A medical affairs employee may understand the safety comparison better than anyone reading the final sales presentation. A regulatory employee may know how the explanation for withdrawing an older product developed. A market access employee may have seen what the company told a Medicaid program. Those perspectives help us examine whether the same facts were presented differently to different audiences.

Insider revelations have mattered across the industry. Public Citizen’s 2018 study, Twenty-Seven Years of Pharmaceutical Industry Criminal and Civil Penalties: 1991 Through 2017, found that whistleblower revelations contributed to 54% of federal pharmaceutical settlements in that period. The value of an insider’s account is the connection it can make between a company’s public explanation and the decisions behind it.

How Much Money Do Pharmaceutical Whistleblowers Get for Exposing Fraud?

A whistleblower case under the False Claims Act can pay 15% to 30% of what the government recovers.

You Know How the Safety Story Was Sold

If you saw a safety comparison become a sales message or a reason to keep a generic out, speak to one of our whistleblower experts about how the safety story was sold. We work with you to build your strongest pharmaceutical whistleblower case, bring in pharmaceutical whistleblower lawyers who know promotion and government payment cases, and stay beside you through the pursuit of a recovery.