Lawmakers Get Few Answers on Root of Opioid Crisis.
No responses to House committee’s letters to drugmakers.
Members of a House committee are trying to find out what role opioid manufacturers are playing in the opioid crisis, but drugmakers and federal officials have been less than fully cooperative.
On Aug. 3, leaders on the House Energy & Commerce Committee, including committee chairman Greg Walden (R-Ore.) and ranking member Frank Pallone (D-N.J.), as well as the senior leadership of the House Oversight & Investigations Subcommittee, sent letters to three opioid manufacturers: Mallinckrodt, INSYS Therapeutics, and Purdue Pharma. Each letter detailed specific allegations against the company involved, followed by requests for both answers to questions and for documentation.
For example, the group’s letter to Saeed Motahari, president and CEO of INSYS, notes that 2 years ago, a federal grand jury indicted the company’s former president and CEO for allegedly participating in an illegal kickback scheme related to the marketing of Subsys, a sublingual fentanyl spray.
After laying out further details of the allegations against the company, the letter says, “The committee has serious concern [sic] regarding INSYS Therapeutics’ marketing and sales practices as well as possible deaths related to the company’s fentanyl spray, Subsys. To assist the committee’s understanding of INSYS’ role in the opioid epidemic in the United States, please provide the following information as well as schedule a briefing on these matters by August 16, 2018.”
The committee then asks a number of questions, including details on how physicians were chosen for INSYS’ speaker program and whether the company has commissioned an internal or independent investigation related to Subsys marketing. The letter also requests training materials given to doctors in the speaker’s program and other documents related to training and sales materials for INSYS marketing and sales staff.
The committee sent similar letters to Mallinckrodt — related to that company’s alleged failure to report suspicious orders for its generic oxycodone to the Drug Enforcement Administration (DEA) — and to Purdue Pharma, in connection with its marketing practices for its extended-release oxycodone (OxyContin). As of Tuesday afternoon, according to a committee source, none of the three companies had responded to the Aug. 3 letters.
DRUGMAKERS AND FEDERAL OFFICIALS
Purdue Pharma and INSYS did not respond to MedPage Today’s request for comment. A spokesman for Mallinckrodt said in an emailed statement that the company and its leadership “have for years been the leader in developing and executing a comprehensive approach to preventing prescription drug diversion, misuse, and abuse, and we look forward to sharing this information and experience with the committee.”
“The company is proud of the fact that Mallinckrodt has long been an industry leader in actively combatting the serious issue of prescription drug abuse with a demonstrated record of complying with the requirements of federal and state laws governing the manufacturing, sale, and distribution of controlled substances,” the statement said.
Mallinckrodt also said it was “cooperating with the committee in its inquiry.” When asked about the Aug. 3 letter, a company spokesman said that “Mallinckrodt has been in contact with the committee and is cooperating, as previously noted.”
An INSYS spokesman also said in an email that the company “will be cooperating with the investigation.”
And the drug companies are not the only entities that the Energy & Commerce Committee is not hearing back from. At a hearing last October, Walden expressed his frustration with the lack of response from the DEA.
“I do want to start with a simple question that this committee has been asking the DEA for months,” Walden said to Neil Doherty, deputy assistant administrator in the DEA Office of Diversion Control. “Which companies supplied the pharmacy in Kermit, West Virginia, that received 9 million opioid pills in 2 years, and the pharmacy in Oceana, West Virginia, that received 600 times as many oxycodone pills as another pharmacy eight blocks away between 2005 and 2016?”
“Thank you for that question, Chairman,” Doherty said. “Currently we are reviewing the request from the committee and I do not have that data with me today. I apologize.”
“So we’ve asked for this information in a meeting; we’ve asked for this information in an email; we’ve asked for this information in a letter; we’ve asked [for] this information now in a hearing,” Walden said. “If you needed to get this information for enforcement action, I suspect and hope you’d get it very quickly, right?”
After another attempt to get information from Doherty failed, Walden said, “I hope you can appreciate our frustration … We’ve been trying to get to the bottom of this pill-dumping issue in West Virginia for a very long time. To me, this is a pretty basic question: Who are the suppliers?”
Walden also criticized the level of response the DEA had given the committee to other questions. “In [a] May letter, we asked the DEA to produce documents about delayed or blocked enforcement actions. Do you know how many documents your agency has produced? The answer is zero … the agency responded, ‘DEA is unaware of documents related to delayed or blocked enforcement actions….'”
Walden held up some papers. “We obtained from another source a whole bunch of documents that look pretty responsive to our request and yet from the agency, we’re told you’re unaware [of such documents]. This is a problem. Enough is enough.”
And the problem isn’t going away: a new report from the CDC found that there were about 72,000 overdose deaths in the U.S. last year, a 10% increase from the previous year, with experts suggesting to the New York Times that the problem may be due to both increasing numbers of people using the drugs and the drugs becoming more deadly.