--- 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 video:duration: 03:10 video:published: 2019-01-17 section: ideas topics: opioid epidemic, OxyContin, Purdue Pharma, pharmaceutical marketing, FDA labeling, addiction, prescription volume, pharmaceutical lawsuits, corporate accountability, US healthcare industry, prescribing reform genre: interview, documentary excerpt tones: critical, serious, investigative, urgent emotions: anger (medium), concern (high), frustration (medium) sentiment: negative audience: general news readers, health policy followers, readers of investigative journalism, people affected by addiction people: Chris McGreal organizations: Purdue Pharma, Food and Drug Administration, TIME products: OxyContin content_suitability: drugs and alcohol [00:00-03:10]; health controversy [00:57-01:36]; death [00:00-03:10]; crime [02:20-02:45] transcript_source: publisher captions transcript_reviewed: not applicable ---  # 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=f4cfa34a-e21a-4bc9-b018-6fa3bd5f36c6&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._ Description, summary, key points, chapters, key quotes, questions and transcript, where present, were produced automatically from the video or its captions and were not reviewed. ## Summary Chris McGreal, author of "American Overdose," discusses why the United States consumes most of the world's prescription opioids. He describes how OxyContin spread from upper Asia into American communities, aggressively marketed by Purdue Pharma with claims about addictiveness that he characterizes as junk science. He notes the resulting lawsuits against drug makers, distributors, pharmacies and doctors, and argues that prescribing must be tightened. ## Key points - The United States consumes 85% of the world's prescription opioids while having 5% of the world's population. (00:02) - Health care in the US is described as a medical industry with money to be made, whereas in most other countries it is a public health service. (00:18) - OxyContin is described as having 10 to 20 times the power of the origin drugs, and it was marketed to marginalized communities. (00:44) - Purdue Pharma's sales force allegedly pushed papers with junk science to doctors making claims about addictiveness. (00:57) - The Food and Drug Administration was persuaded to endorse those addictiveness claims on the pills' labels. (01:08) - A myth was sold that there was no upper limit to taking these drugs and that patients in pain would not become addicted. (01:36) - By 2012, doctors in the US were writing 250 million opioid pain prescriptions a year, roughly one for every adult. (02:03) - McGreal says that although many doctors have been locked up, not a single drug company executive has gone to prison. (02:30) ## Chapters - [00:00 to 00:24] US dominance of opioid prescriptions. McGreal points out the US share of global opioid consumption and frames healthcare as an industry. - [00:24 to 01:08] OxyContin's origins and aggressive marketing. He traces the drug's spread from upper Asia and describes Purdue Pharma's marketing and FDA label claims. - [01:08 to 02:03] Myths, escalating doses and prescription volume. He explains how claims about no upper limit and withdrawal led to escalating use and massive prescription growth. - [02:03 to 03:10] Lawsuits, accountability and prescribing reform. He covers lawsuits against industry players, the lack of executive prison sentences, and calls for tighter prescribing. ## Key quotes - [00:11] Chris McGreal: "Health in this country Is an industry, it's a medical industry." - [00:24] Chris McGreal: "There's money to be made." - [00:57] Chris McGreal: "They pushed papers across to doctors making claims about addictiveness" - [01:36] Chris McGreal: "one of the myths that was sold along with all of this was there was no upper limit to taking these drugs." - [02:30] Chris McGreal: "there hasn't been a single executive, not a single one, has gone to prison for this." ## Questions this video answers - Why does the United States consume such a large share of the world's prescription opioids? [00:02] - How was OxyContin marketed to doctors and patients? [00:44] - What myths about opioid use were promoted alongside these drugs? [01:36] - How many opioid prescriptions were written in the US by 2012? [02:03] - What legal actions have been taken against those involved in the opioid epidemic? [02:20] - What does McGreal say needs to change in prescribing? [02:45] ## Content suitability - drugs and alcohol [00:00-03:10]: Discussion of opioid prescriptions, addiction, and withdrawal throughout. - health controversy [00:57-01:36]: Allegations of junk science and misleading drug label claims by a pharmaceutical company. - death [00:00-03:10]: Opioid epidemic is framed as a public health crisis; overdose deaths are implied rather than explicitly quantified. - crime [02:20-02:45]: References to doctors being locked up and lawsuits against companies. 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 [00:02] 85 % of the world's presrciption opioids are consumed [00:06] in the United States, which is 5 % of the world's [00:08] population. And you think how does one country come [00:11] to be so dependent on these drugs? It is not that the [00:14] United States has 85 % of the world's pain. Health in [00:18] this country Is an industry, it's a medical industry. In [00:21] most other countries, it's a public health service. [00:24] There's money to be made. [ MUSIC ] I [00:30] started this story really where the epidemic begins, [00:33] which is in that little part of Upper Asia where these [00:37] drugs first take off. In a lot of these communities, [00:40] people are already using low level opioids. And then [00:44] this drug comes along called Oxycontin. And it's 10, [00:46] 15, 20 times the power of the [00:50] origin drugs. This drug is so throughout the country but [00:53] targeting these marginalized communities. And by [00:57] sales force by Purdue Pharma that went out with [01:00] essentially junk science. They pushed papers across [01:04] to doctors making claims about addictiveness and they [01:08] persuaded the Food and Drug Administration to [01:11] endorse those claims on the label of The pills and [01:15] these drugs spread very, very quickly. The demand for [01:19] them rises because firstly they're seen as more [01:22] effective. But also the circle of people who become [01:27] dependent and then addicted to them widens very, [01:30] very quickly. And people want more and more of [01:33] them. And the drug companies are willing to sell them [01:36] more and more. And one of the myths that was sold [01:39] along with all of this was there was no upper limit to [01:43] taking these drugs. That you Wouldn't become [01:45] addicted, provided you're in pain. These drugs, which [01:48] I repeat, are our best, strongest pain medications, [01:51] should be used much more than they are for patients [01:53] in pain. People kept taking escalating doses for what [01:57] they thought was dealing with pain. But, in fact, it was [01:59] withdrawal symptoms, if they'd cut back. And this [02:03] created a massive market. By 2012, you [02:07] have doctors in this country writing 250 million [02:10] prescriptions a year for opioid pain medicines, which is [02:13] effectively one for every adult in the country. We're 20 [02:17] years into this epidemic, and there are now A lot of [02:20] lawsuits, particularly, by states attorney generals and [02:23] individual cities against both the drug makers, and the [02:27] drug distributors, and in some cases, the pharmacy, [02:30] and even the doctors. There's plenty of [02:34] doctors that have been locked up, but there hasn't [02:35] been a single executive, not a single one, has gone to [02:38] prison for this. The US still prescribes at three, four, [02:41] five times the rate of most European countries, for [02:45] instance. So if you're not gonna have another [02:48] generation who are open to addiction, there's gotta be [02:52] a much tighter grip on prescribing. And there [02:56] are people who genuinely need these drugs, but [02:58] they're not 190 million people in a country of 360 [03:02] million people. 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