A House committee investigating the opioid crisis is asking three pharmaceutical manufacturers to answer questions and provide documents about their internal practices, including when they learned prescription opioids could be addictive and how they have marketed the drugs.
The House Energy and Commerce Committee and its subcommittee on oversight and investigations sent letters to Purdue Pharma, the maker of OxyContin, and Mallinckrodt Pharmaceuticals, a large manufacturer of generic oxycodone. It also sent a letter to Insys Therapeutics, which manufactured Subsys, a type of fentanyl that is sprayed under the tongue and is meant for carefully monitored patients in severe pain.
The committee has asked Purdue Pharma to provide an unredacted copy of a deposition of Richard Sackler — a doctor, former company president and member of the family that owns Purdue. The deposition is part of a lawsuit that Purdue settled with Kentucky for $24 million.
The letter cites a New York Times story stating that a confidential Justice Department report shows that Purdue knew that OxyContin was addictive shortly after it was put on the market in 1996 — including reports that the pills were being stolen from pharmacies, crushed and snorted — but that the firm did not reveal that information. It said Sackler was told in 1999 about chat-room discussions where people described snorting the time-release painkiller. The report also said prosecutors obtained more than 100 notes from sales representatives from 1997 to 1999 that used the words “street value,” “crush” and “snort” when talking about OxyContin.
The committee is asking Purdue for numerous internal documents relating to when the company knew its product was addictive, including minutes from board meetings and committees at which abuse or the potential for abuse was discussed. Members of Congress also are seeking documents from various executives and sales representatives related to abuse or illegal prescriptions. It is also asking for suspicious order reports, customers it terminated and correspondence between the company and government agencies regarding OxyContin’s abuse and addiction potential.
Purdue said the company plans to cooperate and shares “Congress’ concern about the opioid crisis and have a number of ongoing initiatives to help address it, and we are committed to working collaboratively with policy makers to drive solutions toward this complex issue.”
The letter to Mallinckrodt references a Washington Post story showing that 66 percent of all oxycodone in Florida came from the company. The company last year paid a $35 million settlement for failure to report suspicious orders and other violations.
The committee is interested in the company’s practice of “chargebacks,” which the Justice Department said it was alerted to in the settlement. That is when a manufacturer gives a discount to a drug distributor in exchange for direct consumer information. The letter asks Mallinckrodt when it started receiving the data and for its policies and procedures on suspicious order reporting.
The letter also asks if the company marketed opioids directly to doctors, used sales-based incentive programs and reviewed whether its product could be addictive.
Mallinckrodt said it will comply with the requests and that the company has a “demonstrated record of complying with the requirements of federal and state laws governing the manufacturing, sale and distribution of controlled substances.”
The founder of Insys was charged last year with conspiracy to illegally distribute fentanyl. Prosecutors allege the company was not pleased with its sales numbers and marketed the drug for off-label use, allegedly using bribes and kickbacks such as expensive dinners. The letter states that at least four doctors and several former Insys sales representatives have been convicted of or pleaded guilty to crimes involving the scheme.
The committee wants to know how doctors were chosen for a speaker’s program about the drug and whether the program is still operational. It also requests minutes from any meetings from Jan. 1, 2012, to the present at which abuse or potential abuse of the drug were discussed. The committee asks if the company ever had an internal or independent investigation related to the marketing of Subsys and, if so, to provide copies.
Insys said in a statement that it has received the committee’s letter and “will cooperate with the investigation.”
The committee thus far has focused on opioid distributors. Energy and Commerce Committee Chairman Greg Walden, R-Oregon, and ranking Democrat Frank Pallone Jr., New Jersey, said in a statement that the committee is expanding its investigation and will push for answers throughout the opioid supply chain.
“The opioid crisis continues to destroy the lives of our friends and neighbors, and it’s imperative we examine the full scope of this crisis,” their statement said.
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