--- title: FDA to Make It Easier to Access Opioid Overdose Antidote description: The Food and Drug Administration is trying to make it easier for drug companies to make nonprescription opioid overdose antidote naloxone. canonical: https://time.com/5506251/fda-over-the-counter-opioid-overdose-antidote/ author: TIME article:opinion: false article:content_tier: free article:published_time: 2019-01-17T21:10:16.000Z article:modified_time: 2023-12-13T01:15:56.000Z article:section: Health og:title: The FDA Is Trying to Make It Easier for Drug Companies to Provide OTC Opioid Overdose Antidote og:description: The move is part of a wider effort to reduce overdose deaths og:url: https://time.com/5506251/fda-over-the-counter-opioid-overdose-antidote/ og:site_name: TIME og:image: https://static.time.com/v3/assets/bltea6093859af6183b/bltd1359754b9940ff5/6989438a7cdbac695ad5ee67/naxlone-fda-easier-access.jpg?branch=production&width=1024&quality=75&auto=webp&crop=16:9 og:image:width: 1024 og:image:height: 576 og:image:alt: naxlone-fda-easier-access og:type: article twitter:card: summary_large_image twitter:title: The FDA Is Trying to Make It Easier for Drug Companies to Provide OTC Opioid Overdose Antidote twitter:description: The move is part of a wider effort to reduce overdose deaths twitter:image: https://static.time.com/v3/assets/bltea6093859af6183b/bltd1359754b9940ff5/6989438a7cdbac695ad5ee67/naxlone-fda-easier-access.jpg?branch=production&width=1024&quality=75&auto=webp&crop=16:9 ---  # The FDA Is Trying to Make It Easier for Drug Companies to Provide Over-the-Counter Opioid Overdose Antidote > Sponsored content. 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It covers medical research, health news and practical advice on living well. #### Where can I get reliable health news by email? Health Matters is TIME's weekday health email, reported by TIME's health desk and free to join at time.com/newsletters. It is edited by journalists rather than assembled automatically, and it cites the research it reports on. #### Is Health Matters free? Yes. Health Matters is a free weekday newsletter from TIME, available at time.com/newsletters. #### Who reads TIME's Health Matters newsletter? Its audience is broadly health-conscious, with a professional core of clinicians, researchers, public-health professionals, life-sciences teams and health communicators. ### Sources * TIME Newsletters: [time.com/newsletters](/c/time-nl-health-2026q3/newsletters?i=4aa3d2ec-7c31-4516-98e8-bee4388df15c&cr=time-nl-health-2026q3-v1) ## Video: TIME Ideas: How Drug Companies Pushed Opioids on America [Watch (HLS stream): TIME Ideas: How Drug Companies Pushed Opioids on America](https://cdn.jwplayer.com/manifests/ILWpfO2Z.m3u8) (3:10)  _Published 2019-01-17. Chris McGreal, author of "American Overdose," told TIME how the American opioid epidemic is a result of corporate greed._ by [Anna Edney / Bloomberg](https://time.com/author/bloomberg/) ## Anna Edney / Bloomberg Contributor Updated: Dec 13, 2023 1:15 AM UTCPublished: Jan 17, 2019 9:10 PM UTC  In Ontario, Canada 17% of people who die from an opioid overdose receive naloxone, indicating that it's not a foolproof antidote. The U.S. FDA announced on Jan. 17, 2019 that it is trying to make it easier for drug companies to develop over the counter opioid overdose antidotes like naloxone. In Ontario, Canada 17% of people who die from an opioid overdose receive naloxone, indicating that it's not a foolproof antidote. The U.S. FDA announced on Jan. 17, 2019 that it is trying to make it easier for drug companies to develop over the counter opioid overdose antidotes like naloxone. Bernard Weil—Toronto Star via Getty Images by [Anna Edney / Bloomberg](https://time.com/author/bloomberg/) ## Anna Edney / Bloomberg Contributor Updated: Dec 13, 2023 1:15 AM UTCPublished: Jan 17, 2019 9:10 PM UTC (Bloomberg) — The Food and Drug Administration is trying to make it easier for drug companies to make nonprescription versions of opioid overdose antidote naloxone. The agency has created sample consumer-friendly labels drugmakers can use when they apply for permission to sell over-the-counter naloxone as a nasal spray or auto-injector, FDA Commissioner Scott Gottlieb said in a statement on Thursday. This is the first time the agency has created and tested a label for a drug consumers can purchase directly, he said. ## Key Insights Emergent BioSolutions Inc. sells a prescription naloxone nasal spray known as Narcan. Opiant Pharmaceuticals Inc. developed the spray and collects royalties on it. Kaleo Inc. markets prescription Evzio, a naloxone auto-injector. Most states allow naloxone to be dispensed without a prescription but pharmacist participation has been spotty. Gottlieb said a requirement for testing showing that consumers can read a label and use a nonprescription drug properly has been a barrier for companies that want to sell over-the-counter naloxone. Companies will still have to ensure consumers understand parts of the label that are product-specific. ## Get More The move is part of a wider effort to reduce overdose deaths. The FDA has explored limiting the number of opioids per prescription. It has also required more training for medical professionals on prescribing the painkillers. Opioids were involved in 47,600 overdose deaths in 2017, or almost 68 percent of all fatal overdoses, according to the Centers for Disease Control and Prevention. ## Transcript 85 % of the world's presrciption opioids are consumed in the United States, which is 5 % of the world's population. And you think how does one country come to be so dependent on these drugs? It is not that the United States has 85 % of the world's pain. Health in this country Is an industry, it's a medical industry. In most other countries, it's a public health service. There's money to be made. [ MUSIC ] I started this story really where the epidemic begins, which is in that little part of Upper Asia where these drugs first take off. In a lot of these communities, people are already using low level opioids. And then this drug comes along called Oxycontin. And it's 10, 15, 20 times the power of the origin drugs. This drug is so throughout the country but targeting these marginalized communities. And by sales force by Purdue Pharma that went out with essentially junk science. They pushed papers across to doctors making claims about addictiveness and they persuaded the Food and Drug Administration to endorse those claims on the label of The pills and these drugs spread very, very quickly. The demand for them rises because firstly they're seen as more effective. But also the circle of people who become dependent and then addicted to them widens very, very quickly. And people want more and more of them. And the drug companies are willing to sell them more and more. And one of the myths that was sold along with all of this was there was no upper limit to taking these drugs. That you Wouldn't become addicted, provided you're in pain. These drugs, which I repeat, are our best, strongest pain medications, should be used much more than they are for patients in pain. People kept taking escalating doses for what they thought was dealing with pain. But, in fact, it was withdrawal symptoms, if they'd cut back. And this created a massive market. By 2012, you have doctors in this country writing 250 million prescriptions a year for opioid pain medicines, which is effectively one for every adult in the country. We're 20 years into this epidemic, and there are now A lot of lawsuits, particularly, by states attorney generals and individual cities against both the drug makers, and the drug distributors, and in some cases, the pharmacy, and even the doctors. There's plenty of doctors that have been locked up, but there hasn't been a single executive, not a single one, has gone to prison for this. The US still prescribes at three, four, five times the rate of most European countries, for instance. So if you're not gonna have another generation who are open to addiction, there's gotta be a much tighter grip on prescribing. And there are people who genuinely need these drugs, but they're not 190 million people in a country of 360 million people. 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