By: Michael Lim, PharmD Candidate c/o 2020
As the nation continues to struggle with the growing opioid epidemic, numerous organizations, researchers, and even the president are taking initiative in resolving the crisis. Of these groups, perhaps one of the most proactive in its efforts is the Food and Drug Administration (FDA). With its promotion of innovation and recent involvement in addressing the illicit sale of opioids online, the FDA’s response to widespread opioid misuse and addiction is nothing short of admirable.
Encouraging innovation has been one of the FDA’s key tactics in minimizing the opioid epidemic’s impact on society. One way in which the FDA has supported innovation is through the release of draft guidances which make the pathway for developing new medications more efficient. For example, by issuing the draft guidance, “Opioid Dependence: Developing Buprenorphine Depot Products for Treatment”, the FDA hopes its recommendations will assist industry in streamlining development and foster the exploration of innovations in depot buprenorphine products.1 With wider access to such products, effective treatment for opioid dependence can be provided and as a passive compliance formulation the depots may result in less abuse and misuse compared to self-administered formulations such as tablets or films.2 The FDA has also championed innovation through its approval of new drugs for the treatment and management of opioid use disorder. For instance, the FDA recently approved the first generic forms of sublingual buprenorphine (Buprenex®) and naloxone (Suboxone®) in June 2018.3 In addition, with the FDA’s recent approval of lofexidine (Lucemyra™) – the first non-opioid treatment used to diminish opioid withdrawal symptoms in adults – in May 2018, there is progress in the realm of managing an opioid use disorder on a long-term basis.4 Although treatment with lofexidine cannot exceed fourteen days, by mitigating opioid withdrawal symptoms, it is expected to facilitate abrupt opioid discontinuation.5 Regarding medical devices, the FDA also recently made an effort to cultivate innovation by issuing a challenge to companies to produce devices such as diagnostic tests, mobile medical apps, or support software for the detection, treatment, or prevention of addiction and treatment of pain.6 Regardless of developmental stage, enhanced interactions and review by the FDA is promised for select applicants based on criteria such as feasibility of the product, potential public health impact, and novelty of the device.6
The FDA is also targeting the illegal online opioid market. Illegal opioids sold online are unapproved, potentially adulterated, expired, and/or misbranded, thereby serving as another challenge which exacerbates the current crisis. Of particular concern are opioids such as tramadol (Ultram®) and oxycodone (OxyContin®) which already bear great risks as indicated in their boxed warnings.7 In response, the FDA has issued warning letters to nine online networks hosting 53 websites involved in the illegal sale of opioids.7 With the threat of product seizure or injunction upon failure to implement corrective measures, these online networks are only the first of a comprehensive campaign to suppress the illegal sale of unapproved opioids.7 To continue the campaign, the FDA organized an Online Opioid Summit inviting internet stakeholders, government entities, academic researchers, tech companies, and advocacy groups to address research and other strategies to target the illicit online opioid market.8 While some discussion points were safeguarded to conceal future tactics, the FDA revealed that some approaches discussed at the summit included promoting educational and public health content such as treatment programs in top search results and social media posts, making it more difficult to connect users with digital drug dealers and illegal online pharmacies, and finding ways to use big data and machine learning to identify illegal activity.8 The FDA also mentioned its plans for devoting additional resources to its criminal enforcement network.8
Through innovation and online outreach, the FDA has confronted the burgeoning opioid crisis in a proactive manner. From expanding treatment options to attacking illicit opioid markets, opioid abuse, misuse, and addiction remain targeted on a variety of fronts. While the war to control the epidemic is far from over, the FDA’s inventive and collaborative approach will undoubtedly play a crucial role in finding a resolution.
- Food and Drug Administration. FDA takes new steps to advance the development of innovative products for treating opioid use disorder. Published 04/20/2018. Accessed 6/30/2018.https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm605248.htm
- Food and Drug Administration. Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to encourage more widespread innovation and development of new treatments for opioid use disorder. Published 04/20/2018. Accessed 06/30/2018.https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm605235.htm
- Food and Drug Administration. FDA approves first generic versions of Suboxone sublingual film, which may increase access to treatment for opioid dependence. Published 06/14/2018. Accessed 06/30/2018. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm610807.htm
- Food and Drug Administration. FDA approves the first non-opioid treatment for management of opioid withdrawal symptoms in adults. Published 05/16/2018. Accessed 06/30/2018. https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm607884.htm
- Lucemyra (Lofexidine) [package insert]. Louisville, KY; US WorldMeds, LLC; Revised 05/01/18.
- Food and Drug Administration. As part of efforts to combat opioid crisis, FDA launches innovation challenge to spur development of medical devices ‒ including digital health and diagnostics ‒ that target pain, addiction and diversion. Published 05/30/2018. Accessed 06/30/2018. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm609188.htm
- Food and Drug Administration. FDA takes action against 53 websites marketing unapproved opioids as part of a comprehensive effort to target illegal online sales. Published 06/05/ 2018. Accessed 06/30/2018.https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm609869.htm
- Food and Drug Administration. Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s efforts to collaborate with internet stakeholders to stop the illegal sale of opioids online. Published 06/28/2018. Accessed 06/30/2018.https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm612196.htm