Trump Administration Should Use Rarely Invoked Authority to Expand Access to Opioid Overdose Antidote

May 3, 2018

Trump Administration Should Use Rarely Invoked Authority to Expand Access to Opioid Overdose Antidote

Public Citizen and Baltimore City Health Department Urge Administration to Take Away Monopoly, Help Communities Get More Naloxone

WASHINGTON, D.C. – Public Citizen and the Baltimore City Health Department today called on the Trump administration – which has declared the opioid epidemic to be a public health emergency – to use a rarely invoked authority to lower the price of a critical opioid overdose antidote. This would ensure that community health programs across the nation get wider access to it, and in return provide millions of Americans with access.

“Government use authority” permits (PDF) the federal government to procure generic versions of on-patent medicines. Employing this authority could slash prices for naloxone, the opioid rescue therapy and enable far wider access. Naloxone is available from suppliers in India for as little as 15 cents a dose, meaning that a dose with the generic version of a patented delivery device could be priced dramatically below current U.S. levels.

Although naloxone is generic, Narcan is under patent until March 2035. This means that only one company – Adapt Pharma – can make it, which gives that corporation monopoly power. Similarly, Evzio, the naloxone auto-injector manufactured by Kaléo Pharmaceuticals and whose price spiked from $690 to $4,500 in 2017, is protected by patents until as late as July 2034. But the Trump administration has the power to authorize (PDF) other manufacturers to make competing devices to deliver naloxone, even those that rely on patented technology.

The call for federal action came at a press conference with Dr. Leana Wen, health commissioner of Baltimore; Robert Weissman, president of Public Citizen; Amy Collier, director of the Community Services Division for the Catholic Charities of Baltimore; Nathan Fields, a community health educator for the Baltimore City Health Department; and Perry Hopkins, an overdose survivor whose life was saved through a rapid administration of naloxone.

Under the premise that dispensing the opioid overdose antidote, naloxone – approved in 1971 – should be as easy as pulling a fire alarm, experts including the surgeon general have called for expanded access to the antidote for people struggling with addiction and those around them.

The city of Baltimore, which has been hit particularly hard by the opioid crisis, supplies a nasal spray form of naloxone known as Narcan to the public through education and outreach efforts, as well as through distribution by community groups. In 2015, Wen issued a standing order offering a blanket prescription for naloxone to all of Baltimore’s 620,000 residents. But with a two-pack of Narcan costing $75, the city cannot afford all it needs, so it has been forced to ration its supply.

In a letter (PDF) sent today to White House adviser Kellyanne Conway, appointed to coordinate and lead the White House response to the opioid addiction epidemic, Baltimore City and Public Citizen called on the federal government to authorize the use of all patents necessary to allow for the production of generic naloxone and delivery systems.

Baltimore is the first city in the country to make this request, but all cities would benefit if the Trump administration were to heed it.

“Declaring the opioid addiction epidemic to be a public health emergency, as President Donald Trump has done, is a completely empty gesture unless it is accompanied by action. Employing existing government authority to procure generic versions of naloxone delivery devices wouldn’t cost the government anything and would enable massively expanded access to this lifesaving therapy,” Weissman said. (Read his full statement.)

If the authority were granted, state and local authorities could act as agents of the federal government and buy generic versions of naloxone products directly from manufacturers. Or the Trump administration could buy generic versions of these products and supply them to local health and law enforcement programs, the city and Public Citizen said.

“In Baltimore, everyday residents have saved the lives of more than 1,800 people with naloxone,” Wen said. “Unfortunately, we are having to ration naloxone and make hard decisions about who will receive the medication and who will have to go without because we simply don’t have the resources to purchase this lifesaving antidote. We already have the policies in place to save lives. We are in the middle of a national epidemic. We are calling on the federal government to take action and ensure that we are not priced out of the ability to save lives.” (Read her full statement.)

 “As someone who has worked in the field of substance abuse for 18 years, I am very aware of the problem our country is facing with the opioid epidemic,” Fields said. “I know firsthand that if you save a life today, they can make a better choice tomorrow. Take it from me, take it from someone on the front lines – we need more naloxone and we need it now. ” (Read his full statement.)

“Narcan is a lifesaving and often times life-changing drug that should be available to all programs serving vulnerable populations,” Collier said. “To date, 59 individuals could have died without access to Narcan just in two of Catholic Charities’ programs. It is imperative to make this drug affordable for all at-risk individuals.” (Read her full statement.)

“With Baltimore being a heroin capital of the East Coast, it’s paramount, necessary and mandatory, that production of Narcan be increased and made available,” Hopkins said. “Its availability even outweighs education and outreach because the potency of opioids on the street currently means each person can need two to three Narcan kits to be revived once. Right now the supply of life-saving kits does not meet the demand of the chemical, and that’s killing us.” (Read his full statement.)

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