Dive Brief:
- A group of 50 Democratic congressional members are pressing President Donald Trump to lower prices for the opioid overdose reversal agent naloxone, penning a letter that urges he use a national emergency declaration to empower the Health and Human Secretary to negotiate for reductions in drug cost.
- Spearheaded by Rep. Elijah Cummings, D-MD, the letter draws on recommendations from the Commission on Combating Drug Addiction and the Opioid Crisis, which was set up by Trump in March.
- As the severity of the opioid crisis in the U.S. has become more apparent, drugmakers like Kaleo, Inc. and Adapt Pharma, Inc. have come under political scrutiny for price increases on their treatments for opioid overdoses.
Dive Insight:
Opioid overdose deaths have climbed alarmingly in the U.S., quadrupling between 1999 and 2015, according to data from the Centers for Disease Control and Prevention. Figures cited by Trump's Commission estimate 142 Americans die each day from a drug overdose — a state of affairs the group termed an "unparalleled" epidemic in its interim report.
The Commission's first recommendation is for the president to declare a national emergency, a step Trump has said he will take but has yet to actually do. Making naloxone more available to law enforcement and first responders, as well as authorizing the HHS Secretary to "negotiate reducing pricing for all government units" were among the Commission's other recommendations.
Naloxone was approved as an injectable in 1971 for reversing opioid intoxication or overdose. By 2013, over 80% of naloxone use was for heroin overdoses, despite there being twice as many deaths from prescription opioids, according to research published in The New England Journal of Medicine.
But, as the group of House Democrats note in their letter, prices for naloxone have been rising. Even though the drug went generic in 1985, new formulations such as Adapt's nasal spray or Kaleo's auto-injector version cost more.
In 2009, an injectable or intranasal 1 mg/ml vial made by Amphastar Pharmaceuticals, Inc. was $20.34, rising to $39.60 by 2016, according to the NEJM research. Prices for Hospira's injectable rose from about $63 in 2012 to more than $142 in 2016.
But perhaps the most dramatic was the price hike for Kaleo's Evzio, which cost $690 for a two-pack of prefilled single use injectors. By 2016, Kaleo had increased the price by more than 500% to $4,500 for the pack, attracting attention from lawmakers.
Kaleo has donated more than 250,000 Evzio auto-injectors to health departments and first responders across the country since 2014.
House Democrats want Trump to act on his Commission's findings: "You have the ability to take immediate action to implement these recommendations and make good on your promise to help save the lives of many Americans affected by this national emergency," the lawmakers wrote in the letter to Trump.
While it's not clear if Trump plans to follow through on declaring a national emergency, the White House has reportedly taken steps to advance a public-private partnership with the pharmaceutical industry, according to Politico.
Tackling the opioid crisis has bipartisan support, increasing the pressure on Trump's administration to act forcefully. But if the lack of broader action on drug pricing are any indication, there may be less support in the executive branch for direct government action on prices.