Maryland Attorney General asks judge to order fentanyl manufacturer to turn over documents

Maryland Attorney General Brian Frosh asked a court this week to order a manufacturer of a fentanyl spray to turn over records that investigators think could shed light on deceptive marketing practices.

Frosh’s office has been investigating the firm, Insys Therapeutics, since 2016 as part of a broader probe into companies that make opioids and their role in contributing to the state’s overdose crisis. The office told an Anne Arundel County Circuit Judge that Insys has not been properly responding to subpoenas.

The office filed a petition in court this week asking for the judge’s help to pry loose materials about an under-the-tongue fentanyl spray called Subsys.

While the attorney general’s office has not formally leveled accusations against Insys or any other company, he said in an interview that there are reasons he’s concerned: “There seems to be quite a lot of conduct that if it proves to be true would make these companies liable.”

The move by Frosh’s office comes as jurisdictions in Maryland are stepping up their efforts to hold drug makers and distributors responsible for their alleged role in driving up the number of overdose deaths through sneaky marketing of addictive pills and failing to properly follow state and federal rules.

Last week, Baltimore filed a lawsuit against a handful of companies and a local doctor’s office. And other jurisdictions have joined or are seeking to joined a huge case being handled by a federal judge in Ohio.

Frosh’s Consumer Protection Division is part of a 41-state effort by attorneys general to investigate opioid manufacturers companies. That investigation is separate to the effort involving Insys.

“Insys has been widely accused of engaging in marketing and sales activities that are unfair or deceptive, including marketing Subsys to patients for whom it is inappropriate,” Frosh’s staff wrote in the petition. “It has also been accused of misleading these patients’ insurers, pharmacy benefit managers, and other third-party payers in order to ensure coverage and reimbursement for inappropriate prescriptions.”

The Attorney General’s office said a judge in Anne Arundel County overseeing a private lawsuit recently sanctioned the company for being “equivocal, purposefully evasive and non-responsive.”

Insys could not immediately be reached for comment. In a response issued this month to allegations made by the New York attorney general’s office, it said that Subsys prescriptions accounted for a tiny fraction of opioids in use.

“As the healthcare community and the government seek solutions to our national opioid crisis, which began more than a decade and half ago, and our company looks to put behind it the challenges of the past, it can be disheartening when dialogue on this extremely important topic disregards the enormous amount of data and other facts available to all stakeholders,” the company said in a statement.

In the new petition, Frosh’s office said it issued a subpoena to Insys in December 2016 and gave the company a month to respond. But when the company realized the investigation wasn’t going away, it stopped properly complying, according to the petition.

“Instead, punctuated by long periods of inactivity, it sporadically produced limited sets of documents, usually in response to the Division’s continued demands for compliance,” Frosh’s staff wrote.

Insys has told investigators that it has changed one of the practices being probed but has been unwilling to back up that assertion with documents, according to the petition. The practice is not described in the court document.

“We’re concerned that the practices continue and that’s part of what our investigation is about,” Frosh said in the interview.

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