The FDA has announced that it will hold “a public meeting on September 17, 2019 to further discuss the agency’s benefit-risk assessment of opioid analgesics, including the way risks of misuse and abuse of these products factor into the benefit-risk assessment. This meeting will include a discussion of whether an applicant for a new opioid analgesic should be required to demonstrate that its product has an advantage over existing drugs in order to be approved and, if so, what new authorities the FDA would need to impose such a requirement. In addition, the agency will discuss whether new preapproval incentives (in addition to existing incentives, such as breakthrough designation) are needed to better support and encourage development of all therapeutics – opioid or non-opioid drugs, biological products or devices – intended to treat pain or addiction.”
Details about the Meeting: “The public hearing will be held on September 17, 2019, from 9 a.m. to 5 p.m. The public hearing may be extended or may end early depending on the level of public participation. Persons can attend the event in person or via webcast. In-person attendees can also request to give a formal presentation or to speak during the open public comment portion of the hearing. Section II provides attendance and registration information. Electronic or written comments will be accepted after the public hearing until November 18, 2019.”
Topics for Discussion at the Public Hearing
FDA wants feedback from people who are “working on the challenges of improving pain management and addressing the opioid crisis.”
Below are the questions the FDA is willing to consider for this Public Hearing.
- Does the current statutory and regulatory framework, including the benefit-risk assessment described in the recently issued draft guidance, allow for an adequate evaluation of applications for new opioid analgesics, or are new authorities required? If new authorities are required, please expand on what should be added to the existing statutory and regulatory paradigm.
- Should sponsors of new opioid analgesics be required to demonstrate some comparative advantage relative to existing analgesics? If so, what new authorities would be necessary to impose a comparative advantage requirement for opioid analgesics? If so, how should that comparative advantage be defined? Can it be quantified?
- Should the assessment encompass any potential comparative advantage, including, e.g., safety advantages that reduce the prevalence or consequences of abuse or misuse by non-patient populations?
- For any given application, to which existing products should the proposed new product be required to demonstrate comparative advantage? Any other opioid approved for the same analgesic indication(s) for which approval is sought? What are the implications if the new product only offers a comparative advantage over some of the other opioid products approved for the same indication(s)?
- If a showing of comparative advantage were made a requirement for approval of new opioid analgesics, could a proposed product meet this standard even if the product also carried additional or novel risks compared to existing products?
- If a showing of comparative advantage were made a requirement for approval of new opioid analgesics, should there be any exceptions, with regard to medically necessary drugs in shortage?
- If a showing of comparative advantage were made a requirement for approval of new opioid analgesics, what would be the impact on development of such products?
- If a showing of comparative advantage were made a requirement for approval of new opioid analgesics, what would be the impact on patients, providers, and on the public health generally? Please consider that the existing opioid market consists largely of relatively inexpensive generic drugs.
- In what other ways should FDA be considering the existing armamentarium of therapies to treat pain when reviewing an application for the approval of a new opioid analgesic? To what extent would new authorities be required?
- Please comment on whether new pre-approval incentives are needed to better support and encourage development of therapeutics intended to treat pain or addiction. If so, what new incentives would be most effective, and what new authorities might FDA need to offer them? If the new incentives are offered through a designation process (analogous to breakthrough designation), what should be the criteria for designation?
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov
Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov
Read this link carefully if you are considering submitting your opinions or attending