FDA Wants More Naloxone Available, But Cost Factors Will Have to be Addressed

FDA Wants More Naloxone Available, But Cost Factors Will Have to be Addressed

The FDA wants to increase the supply and use of naloxone across the country to help reduce the terrible toll of lives lost to opioid overdose.

Naloxone is the widely-used life-saving drug that can swiftly reverse the often-fatal effects of an opioid overdose.

To this end, the FDA has announced two days of public meetings in mid-December "to solicit input and advice on strategies to increase the availability of naloxone products intended for use in the community."
"This potentially life-saving treatment is a critical tool for individuals, families, first responders and communities to help reduce opioid overdose deaths," FDA commissioner Scott Gottlieb said. "We recognize that emergency treatment of known or suspected opioid overdose is an urgent public health priority. And to advance these efforts, there is still a need to improve access to naloxone."

Two of the agency's advisory committees, Anesthetic and Analgesic Drug Products and Drug Safety and Risk Management, will consider written and oral presentations from the public and concerned professionals.

"They will help us weigh logistical, economic and harm reduction aspects of different strategies, and we will consider whether naloxone should be co-prescribed with all or some opioid prescriptions to reduce the risk of overdose death," Gottlieb added.

Opioids, naloxone, and money

While the FDA's announcement centers around the potential for co-prescribing naloxone with many types of opioid prescriptions, it doesn't mention anything about the skyrocketing price of naloxone. The only reference to cost is "the potential for significant costs and burdens that may be associated with naloxone co-prescribing."

However, there is an interesting backstory concerning the opioid crisis and naloxone that concerns nothing else except money. It's one that will very likely be introduced by someone at the December meetings.

Cost of heroin

In 1986, a gram of 37% pure heroin, bought in bulk, cost a dealer maybe $1,100 a gram. Cut to perhaps 27% purity or less, it was sold on the street for about $2,200 a gram. The doubling in price was passed on to the end user, who paid maybe $50 or $60 or even twice as much for a .1g bag, depending on purity and availability.

Today, it's an entirely different story. A gram of heroin at the dealer level is less than $500, and on the street, a .1g bag might be $15 or $20, depending on purity. The fact that it might also be cut with deadly fentanyl is an entirely other story.

Cost of naloxone

Meanwhile, we have naloxone, with an almost miraculous record of success at saving people from opioid overdoses. This life-saving drug can reverse an opioid overdose within minutes, sometimes in seconds.

According to Michael Hufford, PhD, and Donald S. Burke, MD, prompt access to naloxone could prevent many, perhaps most of the 115 opioid overdose deaths that occur in the US every day.

But while the cost of heroin has fallen dramatically and the rates of addiction and overdose have soared, the cost of naloxone has skyrocketed from pennies to thousands of dollars. The problem now is that few people in the street, those who really need it, can afford it.

In a recent editorial in STATNews, Hufford and Burke point out that naloxone is cheap to make and has been off patent since 1985.

"Given the ongoing devastation of the opioid crisis, you might expect that naloxone would be widely available at a low price," they write. "Not so. A decade ago, a lifesaving dose of naloxone cost $1. Today, that same dose costs $150 for the nasal spray, a 150-fold increase. A naloxone auto-injector, approved in 2016, costs $4,500.”
"Pharmaceutical innovation hasn't driven up these prices, opportunity has," they added.

It's all about money and marketing

Hufford has 20 years of experience as an entrepreneur in pharmaceutical, medical device and mobile health businesses. He has recently founded a non-profit drug company to develop a cheap version of naloxone that is accessible and affordable.

Burke is Dean of the University of Pittsburgh Graduate School of Public Health, Associate Vice Chancellor for Global Health Sciences, and is the Jonas Salk Professor of Global Health. As an infectious disease specialist, he has particular experience with the dangers of needle-sharing, such as HIV/AIDS and hepatitis.

"The aggressive marketing and sales of highly potent prescription opioids, combined with price-lowering innovations in the production and distribution of heroin, illicit opioids, and fentanyl, have not been matched by innovations in the legal market for naloxone. Its high price and restricted availability - despite its low production costs and excellent safety and effectiveness records - betray our collective ambivalence about the millions of Americans with opioid use disorder," the two wrote in STATNews.

OTC naloxone could work

They say that recent pharmacy programs allowing naloxone to be obtained without a prescription have failed "for three reasons: Most citizens are unaware of these programs, insurance companies rarely provide coverage for naloxone, and the price remains prohibitive."
"We offer a different solution," they said. "Make naloxone available over the counter, in much greater quantities and at lower prices. If for-profit pharmaceutical companies are unable to see past their bottom lines to make naloxone available over the counter and at a low cost, then a nonprofit should step in and do just that, eliminating the exorbitant markups."
They added that the FDA's December public meetings do hold promise. "With a concerted national effort, this can be a solvable problem," they concluded.

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