Posted 05 November 2020 | By
The US Food and Drug Administration (FDA) is seeking to be more transparent about its Risk Evaluation and Mitigation Strategy (REMS) program.
The agency is seeking public comment on its plan to publish its evaluations of how individual drug and biologics sponsors are doing on the implementation of REMS programs.
REMS is a long-standing drug safety program that allows the FDA to require manufacturers to implement specific safety measures that go beyond drug labeling requirements. Currently, drug and biologics manufacturers whose products require a REMS program must submit regular assessments to the FDA. The agency reviews the reports to determine if the REMS is meeting its goals and then files the reviews in its electronic archival record system. In some cases, the FDA’s reviews are shared publicly at the agency’s advisory committee meetings. The reviews can also be requested under the Freedom of Information Act.
But the agency has received feedback from health care providers, industry and researchers that it would be helpful for the manufacturer’s assessment and the FDA’s review to be made public. “For example, industry members may consider the effectiveness of a particular strategy as they develop a new REMS; healthcare providers may have an interest in the assessment of a REMS that they participate in; and academics can use the information for research purposes,” the agency wrote in the Nov. 5 Federal Register notice requesting public comment on its plan.
As a result, the agency is proposing to create a “Summary of the REMS Assessment” that would include high-level data from the manufacturer’s assessment report and the FDA’s review. The Summary report would be posted online to the Approved REMS webpage.
The FDA would notify the manufacturer prior to posting the report online and the summaries would not include confidential commercial information.
Overall, the FDA plans to publish information on approved indication, the safety issue warranting a REMS, the goals and requirements of the REMS, and the timetable for submissions. The report would also offer a brief summary of the results of the data used to inform evaluation of each REMS objective, as well as conclusions from the FDA and the sponsor on whether the REMS its meeting its goals. Finally, the next steps section would explain whether the FDA required modifications to the existing REMS program.
The FDA is asking stakeholders to comment on what information should be posted as part of the Summary of the REMS Assessment. The agency is also asking whether the proposed report would be beneficial to the public and specifically to health care stakeholders.
The request for comment was published on 5 November; the public has 60 days to submit electronic or written comments. Electronic comments can be submitted through the federal e-rulemaking portal at www.regulations.gov.
The FDA has recently come under fire from the Health and Human Services Office of the Inspector General (OIG) for using the REMS program ineffectively to control the opioid epidemic. The OIG concluded, in a report published in September 2020, that data quality issues within the REMS program made it difficult to track compliance by prescribers of two major classes of opioid drugs – transmucosal immediate-release fentanyl drugs and extended-release/long-acting opioids. (RELATED: Report: FDA REMS program ineffective at curbing opioid misuse, Regulatory Focus 02 October 2020).
The FDA will be exploring the use of REMS for opioid analgesics in an upcoming all-day public workshop on 11 December 2020. The workshop will be held virtually and broadcast via webcast.
Federal Register
The agency is seeking public comment on its plan to publish its evaluations of how individual drug and biologics sponsors are doing on the implementation of REMS programs.
REMS is a long-standing drug safety program that allows the FDA to require manufacturers to implement specific safety measures that go beyond drug labeling requirements. Currently, drug and biologics manufacturers whose products require a REMS program must submit regular assessments to the FDA. The agency reviews the reports to determine if the REMS is meeting its goals and then files the reviews in its electronic archival record system. In some cases, the FDA’s reviews are shared publicly at the agency’s advisory committee meetings. The reviews can also be requested under the Freedom of Information Act.
But the agency has received feedback from health care providers, industry and researchers that it would be helpful for the manufacturer’s assessment and the FDA’s review to be made public. “For example, industry members may consider the effectiveness of a particular strategy as they develop a new REMS; healthcare providers may have an interest in the assessment of a REMS that they participate in; and academics can use the information for research purposes,” the agency wrote in the Nov. 5 Federal Register notice requesting public comment on its plan.
As a result, the agency is proposing to create a “Summary of the REMS Assessment” that would include high-level data from the manufacturer’s assessment report and the FDA’s review. The Summary report would be posted online to the Approved REMS webpage.
The FDA would notify the manufacturer prior to posting the report online and the summaries would not include confidential commercial information.
Overall, the FDA plans to publish information on approved indication, the safety issue warranting a REMS, the goals and requirements of the REMS, and the timetable for submissions. The report would also offer a brief summary of the results of the data used to inform evaluation of each REMS objective, as well as conclusions from the FDA and the sponsor on whether the REMS its meeting its goals. Finally, the next steps section would explain whether the FDA required modifications to the existing REMS program.
The FDA is asking stakeholders to comment on what information should be posted as part of the Summary of the REMS Assessment. The agency is also asking whether the proposed report would be beneficial to the public and specifically to health care stakeholders.
The request for comment was published on 5 November; the public has 60 days to submit electronic or written comments. Electronic comments can be submitted through the federal e-rulemaking portal at www.regulations.gov.
The FDA has recently come under fire from the Health and Human Services Office of the Inspector General (OIG) for using the REMS program ineffectively to control the opioid epidemic. The OIG concluded, in a report published in September 2020, that data quality issues within the REMS program made it difficult to track compliance by prescribers of two major classes of opioid drugs – transmucosal immediate-release fentanyl drugs and extended-release/long-acting opioids. (RELATED: Report: FDA REMS program ineffective at curbing opioid misuse, Regulatory Focus 02 October 2020).
The FDA will be exploring the use of REMS for opioid analgesics in an upcoming all-day public workshop on 11 December 2020. The workshop will be held virtually and broadcast via webcast.
Federal Register
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