September 7, 2018

FDA Reassesses Opioid Policies

As the opioid epidemic continues to permeate the country, the FDA has increasingly announced initiatives to influence the prescribing landscape. This includes efforts to better educate prescribers, bolster opioid prescribing guidelines and influence the drug development cycle.

First, the FDA has approved significant updates to the opioid analgesic risk evaluation and mitigation strategy (REMS). REMS enforces significant education requirements that prescribers must complete in order to prescriber opioid medications. However, REMS was previously only applicable to extended-release and long-acting opioid medications. For the first time, REMS will now apply to immediate-release opioids, which are estimated to make up 90% of opioid prescriptions. This means REMS will go from applying to 62 opioid products to 347.

By demanding that prescribers undergo further education on topics such as opioid risks, alternatives, adverse effects, aberrant behavior, tapering, discontinuing, and more, it is the FDA’s hope to influence opioid prescribing. Furthermore, these REMS updates require that more extensive education be made available to other healthcare providers involved in the management of pain, including nurses and pharmacists

The FDA also announced plans to develop new, indication-specific, evidence-based guidelines for appropriate opioid therapy for acute pain. This plan involves awarding a contract to the National Academies of Sciences, Engineering, and Medicine (NASEM) to conduct studies and public workshops that engage prescribers and other stakeholders, identifying what procedures and conditions associated with acute pain are most commonly prescribed opioids.

NASEM will then prioritize where evidence-based clinical practice guidelines are most needed to help influence prescribing practices, giving the FDA insight on guidelines which they will then generate.

While no word has been given yet as to when such guidelines would be developed, and if such guidelines would be voluntary or mandatory, the introduction of FDA-approved opioid prescribing guidelines could carry significant weight and positively influence prescribing behavior. Furthermore, NASEM’s findings may even potentially influence FDA drug labelling, which could also influence prescribing behavior.

The FDA also announced that they would withdraw 2014 industry guidance related to the development of new pain-relief medications, choosing to replace them with four new guidance documents over the next six-to-twelve months.

This action indicates a potential shift in the types of drugs the FDA seeks to approve, as three of these guidance documents focus on opioid alternatives. One will address alternative medications that can be used in lieu of opioids, while another outlines a path for the development of extended-release local anesthetics that can serve as an opioid alternative. The third would assist sponsors in the development of new, non-opioid chronic pain medications.

The final guidance document will focus on pushing drug makers to better assess the benefits and risks of new opioids in development. The FDA hopes to accomplish this by creating an updated framework for evaluating risks associated with intentional or illicit misuse or abuse of drugs, which opioid developers must work with if they wish to see their drugs approved.

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