Life Science Compliance Update

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December 20, 2017

FDA to Host Meeting on Opioid Prescribing Information Implementation


On January 30, 2018, the United States Food and Drug Administration (FDA) will host a public meeting entitled, “Opioid Policy Steering Committee: Prescribing Intervention – Exploring a Strategy for Implementation.” The FDA hopes to receive stakeholder input on how the agency can improve the safe use of opioid analgesics by curbing overprescribing to decrease the occurrence of new addictions and limit the misuse and abuse of opioids, under the FDA Risk Evaluation and Mitigation Strategy (REMS).

Recent studies suggest that prescriptions for opioid analgesics are frequently dispensed for a number of tablets that exceed those needed for adequate pain control, particularly for acute pain. The Steering Committee is considering whether current prescribing patterns are contributing to the development of new addiction in patients, and whether the excess unused pills are a gateway to misuse, abuse, and addiction among family members and others who might have access to the unused pills. Therefore, the Steering Committee is exploring the option of simplifying prescribing by requiring sponsors to implement a prescriber intervention at the point when the prescriber determines an opioid analgesic prescription is necessary for a patient.

The Steering Committee's view is that sponsors could implement this type of prescribing documentation requirement through an electronic system incorporated into the prescriber's workflow to minimize the burden on patient access and on the health care delivery system. Thus, the Steering Committee is interested in exploring evidence-based approaches that would encourage electronic prescribing as a mechanism for the prescriber to provide documentation of a safe-use condition before the drug is dispensed by the pharmacy. The Steering Committee also seeks input from the public on alternative REMS models or approaches for consideration.

The FDA is focused on several main questions, including:

  1. If a REMS were to specify threshold drug amounts for opioid analgesic prescriptions above which prescribers would be required to provide additional documentation of medical necessity, what should the amounts be and how should they be determined for various clinical indications? What data are there to support such amounts? What additional data would be useful?
  2. If such measures were required, how should prescribers be made aware of them? Within the Agency's statutory REMS authority, how should the Agency require sponsors to ensure compliance with them? How should the Agency require sponsors to assess their effect in reducing misuse, abuse, and new addictions?
  3. The Steering Committee requests input from the public on whether, in addition to, or in conjunction with the above described prescriber intervention, and to the extent consistent with its statutory authority, the Agency should consider requiring sponsors to create a system that utilizes a nationwide prescription history database to facilitate safe use of opioid analgesics.
  4. If this approach were adopted, how should the Agency require sponsors to assess the impact of such requirements?

FDA is seeking feedback from a broad group of stakeholders, both private and public, who are working on the challenges of improving pain management while addressing the opioid epidemic. The Agency is also particularly interested in ensuring that any REMS intervention minimizes the burden on patient access and, to the extent practicable, on the health care delivery system. Relevant questions for consideration are provided below.

For comments on the topic, you can submit written submissions to the Dockets Management Staff (HFA-305). All submissions received must include the Docket No. FDA-2017-N-6502 for “Opioid Policy Steering Committee: Prescribing Intervention—Exploring a Strategy for Implementation; Public Hearing; Request for Comments.” Comments filed in a timely manner, will be placed in the docket and, except for those submitted as “Confidential Submissions,” be publicly viewable at or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

If you wish to attend this meeting, and/or present at the meeting, you need to register with the Agency by January 16, 2018.

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