Opiate Regulation Gets a Major Makeover
[Posted on: Thursday, 24 March, 2016]

FDA and CDC took several major steps this month to address abuse of prescription opiates. Opiate abuse is a major healthcare issue and has been termed a “crisis” and an “epidemic”. A detailed action plan was announced by FDA last month, one of the first major actions by the new FDA Commissioner.  Abuse or Overdose accounts for about 11000 deaths and about 420000 emergency room visits every year in the US. There are 18 opioid drugs and about 60 products in the US market. About 1 in 5 Americans are prescribed opiates for pain management; about 2 million people are reported to abuse prescription opiates or be addicted to them. The issue has become so prominent that the current FDA Commissioner’s confirmation was held up in Congress for lack of promise to reform approval of new opioid drugs by FDA. Opioid drugs are sold in two major formulations; the lower dose immediate release (IR) formulation that needs to be consumed every 4-6 hrs, and the higher dose extended release and long acting (ER/LA) formulations that usually taken once a day or less frequently. In 2013, FDA implemented the rule to require all ER/LA formulations to carry additional black-box warnings and safety information to inform doctors about the risk of prescribing and how to prescribe safely. This week, FDA added the same requirement for the IR formulations as well. Under the new requirement, all IR formulations for opiates will require a new label which will contain much more detailed warning about abuse potential and when not to use. Although the labeling requirements for both ER/LA and IR formulations are mostly identical, FDA still believes that the risk posed by the two categories of formulations are very different and that the two formulations needs distinct pharmacovigilance efforts. The FDA decision was preceded last week by a new CDC guidelines for physicians for prescribing opioid pain medication for chronic pain. CDC lists several criteria to identify when to prescribe or continue opioids for chronic pain management; how to select a particular opioid drug, its dose, duration, follow-up and discontinuation; and how to assess risk of abuse and address harm due to abuse. While the FDA guidance is directed to manufacturers and patients, the CDC guideline is focused on physicians. The CDC guideline provides a very comprehensive background of the problem, and detailed instructions, checklists and summary tables to help physicians customize the treatment, and evaluate the patients for effective pain management while avoiding or at least minimizing risk of abuse. Physicians are counseled to try non-opioid treatment options as much as possible. CDC plans to distribute its guidelines and related tools to health systems, medical professional societies, insurers, public health departments, health information technology developers and clinicians.  The purpose to robust education of all prescribers in the current recommendations. Although adoption of the CDC guidelines is voluntary and doctors are advised to follow whatever treatment regimen they feel is suitable for the given patient, it is expected that these guidelines will give prosecutors grounds to take action against physicians deemed to have failed to ensure that prescriptions were issued for a legitimate medical purpose. By addressing the abuse both at the regulatory and medical practice levels, FDA and CDC seem to create a closed loop system to ensure all parties take adequate strong action to control opioid abuse. Past regulatory actions have had limited impact as indicated by the constantly increasing rate of opioid prescriptions and increased rate of abuse, addiction and death. Is FDA fighting a battle it cannot win, time will tell.