WASHINGTON – U.S. Senator Claire McCaskill, the top-ranking Democrat on the Senate Homeland Security and Governmental Affairs Committee, today demanded answers from the Department of Health and Human Services (HHS) on its efforts to address the skyrocketing price of naloxone—a life-saving drug that can reverse an opioid overdose—after failing to receive those answers in a series of recent Senate hearings.
“When it comes to bringing down the price of naloxone, it isn’t just about saving money—we’re talking about saving lives,” McCaskill said. “As the opioid epidemic continues to devastate Missouri communities, I’m going to keep fighting to make sure law enforcement officials and other first responders have the tools they need to tackle this public health crisis, including this life-saving drug.”
Prices for naloxone have seen sharp increases in recent years. In one case, the price of two doses of the Evzio naloxone product, manufactured by Kaléo Pharma, increased from $690 in 2014 to $4,500 in 2016—more than 500 percent. Last year, McCaskill joined a group of senators in demanding answers from Kaléo Pharma about this dramatic price hike. This year, she asked HHS Assistant Secretary for Health Admiral Brett P. Giroir about naloxone price increases at a hearing in April, and she asked Centers for Medicare & Medicaid Services Administrator Seema Verma about HHS outreach on price increases at a hearing last month.
In a letter to HHS Secretary Alex Azar, McCaskill wrote, “At a hearing of the Senate Committee on Finance in April 2018, I asked Admiral Brett P. Giroir, the Assistant Secretary for Health at the U.S. Department of Health and Human Services (HHS), whether HHS had demanded explanations from pharmaceutical manufacturers that had raised prices for the opioid-reversal drug naloxone. Admiral Giroir stated he had not asked the companies to explain their dramatic price increases, but promised he would ‘get back to [me] on whether [he] could write a letter.’ I am not aware, however, of outreach from HHS to my office on this issue.”
In November 2017, the President’s Commission on Combating Drug Addiction and the Opioid Crisis recommended that the HHS Secretary be empowered to negotiate reduced pricing for governmental units of naloxone. In her letter, McCaskill also asked for an explanation regarding any actions HHS has taken to empower the Secretary to negotiate directly with manufacturers to reduce naloxone costs.
McCaskill has made tackling rising healthcare and prescription drug costs, including the price of naloxone, a top priority in the Senate. As the top Democrat on the Senate Special Committee on Aging, she joined Republican Chairman Susan Collins to launch a bipartisan inquiry into naloxone manufacturers regarding price increases that have limited the availability of naloxone. Last year, she requested information from naloxone manufacturers about their discount and charitable programs for community groups and local law enforcement to determine their efforts to increase naloxone availability.
McCaskill also launched an investigation into opioid manufacturers last year—the most comprehensive Congressional investigation into the crisis to date—when she requested information related to sales and marketing materials, internal addiction studies, details on compliance with government settlements and donations to third party advocacy groups from major opioid manufacturers. Later, she expanded her investigation, requesting documents and information from opioid manufacturers Mallinckrodt, Endo, Teva, and Allergan, while a request to McKesson Corporation, AmerisourceBergen Corporation, and Cardinal Health, Inc., focused on their distribution of opioid products.
In September of last year, McCaskill announced the first round of findings, detailing systemic manipulation of the prior authorization process by Insys Therapeutics. Earlier this year in February, McCaskill’s investigation released another round of findings, exposing the financial ties between opioid manufacturers and third party groups, who often lobbied for pro-opioid policies after receiving contributions from pharmaceutical companies. In the wake of these discoveries, McCaskill introduced a bill in June to increase transparency and make sure opioid manufacturers report contributions to third party groups, which totaled almost $9 million between 2012 and 2017 for the companies and groups profiled in the February 2018 report. In July, McCaskill released another report as part of her investigation into opioid manufacturers, documenting how the “Big Three” pharmaceutical distribution companies together shipped around 1.6 billion dosage units of opioid products to Missouri alone between 2012 and 2017 and how their legally required suspicious order reporting for Missouri orders between 2012 and 2017 varied widely.
Read McCaskill’s letter to HHS HERE.