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$1.4 billion settlement against opioid manufacturer puts spotlight on generic drugs, treatment gaps
The lawsuit involving the manufacturer of Suboxone film that was settled earlier this month for a record-breaking $1.4 billion could change the generic drug approval process and highlighted treatment barriers for patients with opioid use disorder, legal experts told Healio Primary Care.
David L. Noll, JD, an associate professor of law at Rutgers Law School, and Regina LaBelle, JD, program director at the O’Neill Institute for National and Global Health Law at Georgetown University, discussed how the settlement between London-based Reckitt Benckiser Group plc, the Department of Justice and Federal Trade Commission regarding Suboxone film could lead to significant changes in the medical, marketing and legal arenas.
Restraining generic competition
Some of the claims the federal government had made against Reckitt Benckiser Group plc surrounded generic versions of Suboxone film (buprenorphine/naloxone, Indivior), Noll said in the interview.
“Reckitt Benckiser Group was accused of taking actions that slowed the approval of generic versions of that product. This would figure into a broader scheme to increase Suboxone sales by driving sales of Suboxone to Reckitt Benckiser Group rather than generic competitors. Although there are no findings of liability, Reckitt Benckiser Group plc’s agreement to pay $50 million to resolve the claim that it had obstructed approval of generics suggests that the Federal Trade Commission believes the entry of generics had been delayed,” he said in the interview.
He explained how the pre-trial agreement impacts would-be manufacturers of Suboxone generics in the future.
“The settlement bars Reckitt Benckiser Group plc from filing a citizen petition that challenges the approval of generics unless it files ‘all studies and data relevant to that Citizen Petition,’” Noll continued.
“This is an effort to ensure that Reckitt Benckiser Group plc does not use citizen petitions to hold up the approval of generics. Following this settlement, generics will be on notice that approval applications won't be opposed by Reckitt Benckiser Group plc. However, these generics still need to go through the ordinary FDA approval process,” he added.
“It’s also notable that the Department of Justice was originally looking for about $3 billion in this case. The amount of compensation that the settlement provides — about half of that — is high for this type of litigation,” Noll continued.
The company’s willingness to settle for a higher amount may have reflected its desire to avoid a larger financial loss, he said.
“If Reckitt Benckiser Group plc had been found liable of violating the False Claims Act, it would be excluded from federal contracting. Medicaid and Medicare are the largest purchasers of pharmaceuticals in the United States. Reckitt Benckiser Group plc must have known that being excluded from that market would be a death blow,” Noll said.
Treatment gaps
Studies suggest that one potential reason for the opioid epidemic is lack of patient access to buprenorphine. A 2017 report in Annals of Family Medicine concluded that approximately one-third of 1,124 rural physicians who had waivers to prescribe buprenorphine said they do not currently prescribe it. In addition, a survey of 474 American Psychiatric Association members found that more than 50% of respondents who had waivers but were under-prescribing the medication were reluctant to prescribe to capacity and nothing could convince them to do so.
LaBelle told Healio Primary Care that the $1.4 billion settlement brings attention to the “yawning treatment opioid gap” in the United States.
“We need more health care professionals who can treat people with substance use disorders and receive addiction treatment training in the course of their professional education,” she said in an interview.
Comparisons to civil lawsuit in Ohio
The settlement between Reckitt Benckiser, the Department of Justice and Federal Trade Commission comes several months before opening arguments are slated to begin in Ohio in a federal case involving hundreds of communities in the United States and Purdue Pharma, Johnson & Johnson, Teva Pharmaceutical Industries and Endo International, and drug distributors AmerisourceBergen Corp, Cardinal Health Inc. and McKesson.
The Ohio case stems from allegations that contend the companies ignored warning signs that people were taking opioids for reasons other than their intended use.
“The products being marketed are different in these cases,” LaBelle said. “However, the marketing practices by the pharmaceutical industry are implicated in all of these cases. Legally the case won't affect the other lawsuits against the opioid manufacturers and distributors. But these types of lawsuits send a message about how seriously false claims and deceptive marketing practices are taken,” she said.
Court documents indicate the Ohio case will start Oct. 21 of this year. Check Healio Primary Care for continuing coverage.
Healio’s Opioid Resource Center compiles the latest stories across a range of specialties, covering the latest information on the opioid crisis, including treatment strategies, FDA decisions on treatments and other related announcements. Be sure to bookmark the page for future reference. – by Janel Miller
Disclosures: Noll reports no relevant financial disclosures on this topic. LaBelle reports previously advising a law firm representing municipalities in the federal lawsuit against Purdue Pharma.