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Committee Detail

Note: An Annual Comprehensive Review, as required by §7 of the Federal Advisory Committee Act, is conducted each year on committee data entered for the previous fiscal year (referred to as the reporting year). The data for the reporting year is not considered verified until this review is complete and the data is moved to history for an agency/department. See the Data From Previous Years section at the bottom of this page for the committee’s historical, verified data.

Details on agency responses to committee recommendations can be found under the Performance Measures section for each committee in the fields “Agency Feedback” and “Agency Feedback Comment.”


HHS - 847 - Drug Safety and Risk Management Advisory Committee - Authorized by Law
Hide Section - GENERAL INFORMATION

GENERAL INFORMATION

Committee NameDrug Safety and Risk Management Advisory CommitteeAgency NameDepartment of Health and Human Services
Fiscal Year2022Committee Number847
Original Establishment Date11/28/1990Committee StatusChartered
Actual Termination Date Committee URLhttp://www.fda.gov/AdvisoryCommittees/Committee...
New Committee This FYNoPresidential Appointments*No
Terminated This FYNoMax Number of Members*12
Current Charter Date5/31/2022Designated Fed Officer Position Title*Designated Federal Officer
Date Of Renewal Charter5/31/2024Designated Federal Officer Prefix
Projected Termination Date Designated Federal Officer First Name*Philip
Exempt From Renewal*NoDesignated Federal Officer Middle NameA.
Specific Termination AuthorityDesignated Federal Officer Last Name*Bautista
Establishment Authority*Authorized by LawDesignated Federal Officer SuffixPharm.D.
Specific Establishment Authority*21 U.S.C. 394Designated Federal Officer Phone*(301) 796-9001
Effective Date Of Authority*11/28/1990Designated Federal Officer Fax*301-847-8533
Exempt From EO 13875 Discretionary CmteNot ApplicableDesignated Federal Officer Email*philip.bautista@fda.hhs.gov
Committee Type*Continuing
Presidential*No
Committee Function*Scientific Technical Program Advisory Board
Hide Section - RECOMMENDATION/JUSTIFICATIONS

RECOMMENDATION/JUSTIFICATIONS

Agency Recommendation*Continue
Legislation to Terminate RequiredNot Applicable
Legislation StatusNot Applicable
How does cmte accomplish its purpose?*The Committee advises the Commissioner of Food and Drugs on risk management, risk communication, and quantitative evaluation of spontaneous reports for drugs for human use and for any other product for which the Food and Drug Administration has regulatory responsibility. The Committee also advises the Commissioner of Food and Drugs regarding the scientific and medical evaluation of all information gathered by the Department of Health and Human Services and the Department of Justice with regards to safety, efficacy, and abuse potential of drugs or other substances, and recommends actions to be taken by the Department of Health and Human Sevices with regard to the maketing, investigation, and control of such drugs or other substances.
How is membership balanced?*Members are authorities in the fields of risk communication, risk management, drug safety, medical, behavioral, and biological sciences as they apply to risk management, and drug abuse. The Committee includes one technically qualified voting member who is identified with consumer interests. The Committee may include one non-voting member identified with industry interests.
How frequent & relevant are cmte mtgs?*In FY-22, the Committee met once. At this meeting, the Drug Safety and Risk Management Advisory Committee met in joint session with another committee but was not the lead committee. See the Agency Recommendations, Remarks section details about this joint meeting in which the Committee was not the lead committee.

On February 15, 2022, the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee discussed new drug application (NDA) 213231, for tramadol hydrochloride injection, submitted by Avenue Therapeutics, Inc., for the management of moderate to moderately severe pain in adults in a medically supervised healthcare setting. The issues for the committees to discuss included the clinical relevance of tramadol hydrochloride injection, an opioid intended for management of acute pain in a medically supervised healthcare setting, when its onset of action is delayed, and its proposed dosing is a fixed-dosing regimen.

It is expected that the Committee will meet three to six times in FY-23.
Why advice can't be obtained elsewhere?*Members of the Committee are drawn from academia, research and/or clinical practice. Their advice and input lends credibility to regulatory decisions made and helps those decisions stand up to intense public scrutiny. The alternate means of obtaining this advice would be to hire large numbers of scientists on a full time basis at a great expense to the government.
Why close or partially close meetings?The committee held no closed meetings during FY-22.
Recommendation RemarksThere were no reports required for this Committee in FY-22.

In FY-22, the Committee met once. At this meeting, the Drug Safety and Risk Management Advisory Committee, met in joint session with another committees but was not the lead committee.

On February 15, 2022, the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee discussed new drug application (NDA) 213231, for tramadol hydrochloride injection, submitted by Avenue Therapeutics, Inc., for the management of moderate to moderately severe pain in adults in a medically supervised healthcare setting. The issues for the committees to discuss included the clinical relevance of tramadol hydrochloride injection, an opioid intended for management of acute pain in a medically supervised healthcare setting, when its onset of action is delayed, and its proposed dosing is a fixed-dosing regimen. A majority of members (8 Yeses and 14 Noes) voted that the Applicant did not submit adequate information to support the position that the benefits for their product outweigh the risks for the management of acute pain severe enough to require an opioid analgesic in an inpatient setting. Agency Action: The Agency is reviewing recommendations made at the meeting.


Although the current charter states that the committee shall hold meetings approximately three to six times a year, this is only an estimation based on data from previous years. As the FDA convenes advisory committees regarding based on the needs of the Agency, it should not be construed as an exact figure.
Hide Section - PERFORMANCE MEASURES

PERFORMANCE MEASURES

Outcome Improvement To Health Or Safety*YesAction Reorganize Priorities*Yes
Outcome Trust In GovernmentYesAction Reallocate ResourcesYes
Outcome Major Policy ChangesYesAction Issued New RegulationsYes
Outcome Advance In Scientific ResearchYesAction Proposed LegislationYes
Outcome Effective Grant MakingNoAction Approved Grants Or Other PaymentsNo
Outcome Improved Service DeliveryNoAction OtherYes
Outcome Increased Customer SatisfactionYesAction CommentFDA approves or chooses not to approve an investigational new medical product.
Outcome Implement Laws/Reg RequirementsYesGrants Review*No
Outcome OtherNoNumber Of Grants Reviewed0
Outcome CommentN/ANumber Of Grants Recommended0
Cost Savings*Unable to DetermineDollar Value Of Grants Recommended$0.00
Cost Savings CommentThe utilization of the Drug Safety and Risk Management Drugs Advisory Committee enabled the Agency to obtain required and frequently scarce professional services from medical and scientific experts not otherwise available to the Agency; and to obtain the services of these experts only on an as needed basis rather than on a full time basis. The service of the Committee resulted in advice for the improvement of the public health, for which it is difficult to assign a financial value.Grants Review CommentN/A
Number Of Recommendations*74Access Contact Designated Fed. Officer*Yes
Number Of Recommendations CommentThe Committee made 74 recommendations from FY-03 through FY-22.Access Agency WebsiteYes
% of Recs Fully Implemented*84.00%Access Committee WebsiteYes
% of Recs Fully Implemented CommentThe function of an advisory committee is purely advisory in nature. Although the FDA most often accepts the recommendations from its committees, the advice is purely advisory in nature, therefore, the Agency has the option of not implementing the advice. This number represents an approximation of the percentage of recommendations that the agency has fully implemented or plans to fully implement.Access GSA FACA WebsiteYes
% of Recs Partially Implemented*10.00%Access PublicationsYes
% of Recs Partially Implemented CommentThe function of an advisory committee is purely advisory in nature. Although the FDA most often accepts the recommendations from its committees, the advice is purely advisory in nature, and therefore, the Agency has the option of not implementing the advice.Access OtherNo
Agency Feedback*YesAccess CommentN/A
Agency Feedback Comment*When appropriate, information is made available to the public. Actions related to guidance documents or other general matters or issues are available publicly when implemented. Please see https://www.fda.gov/.Narrative Description*FDA’s strategic priorities in responding to the public health challenges of the 21st century are to advance regulatory science and innovation; strengthen the safety and integrity of the global supply chain; strengthen compliance and enforcement activities to support public health; expand efforts to meet the needs of special populations; advance medical countermeasures and emergency preparedness; advance food safety and nutrition; promote public health by advancing the safety and effectiveness of medical products; establish an effective tobacco regulation, prevention, and control program; and manage for organizational excellence and accountability. The Drug Safety and Risk Management Advisory Committee supports FDA's strategic priorities by reviewing and evaluating available data on risk management, risk communication, and quantitative evaluation of spontaneous reports for drugs for human use and for any other product for which the Food and Drug Administration has regulatory responsibility and making appropriate recommendations to the Commissioner of Food and Drugs. The Committee also advises the Commissioner of Food and Drugs regarding the scientific and medical evaluation of all information gathered by the Department of Health and Human Services and the Department of Justice with regard to safety, efficacy, and abuse potential of drugs or other substances, and recommends actions to be taken by the Department of Health and Human Services with regard to the marketing, investigation, and control of such drugs or other substances. This supports the development of safe and effective new medical technologies, and advances the status of the Agency as a science-based and science-led regulatory agency, providing global leadership in the protection of public health.
Hide Section - COSTS

COSTS

Payments to Non-Federal Members*$5,067.00Est Payments to Non-Fed Members Next FY*$32,978.00
Payments to Federal Members*$563.00Est. Payments to Fed Members Next FY*$4,711.00
Payments to Federal Staff*$191,891.00Estimated Payments to Federal Staff*$190,419.00
Payments to Consultants*$0.00Est. Payments to Consultants Next FY*$0.00
Travel Reimb. For Non-Federal Members*$0.00Est Travel Reimb Non-Fed Members nextFY*$0.00
Travel Reimb. For Federal Members*$0.00Est Travel Reimb For Fed Members*$0.00
Travel Reimb. For Federal Staff*$0.00Est. Travel Reimb to Fed Staff Next FY*$0.00
Travel Reimb. For Consultants*$0.00Est Travel Reimb to Consultants Next FY*$0.00
Other Costs$51,440.00Est. Other Costs Next FY*$61,614.00
Total Costs$248,961.00Est. Total Next FY*$289,722.00
Date Cost Last Modified10/8/2022 4:58 PMEst. Fed Staff Support Next FY*1.10
Federal Staff Support (FTE)*1.10Est Cost Remarks
Cost Remarks  
Hide Section - Interest Areas

Interest Areas

Category
Area
Food and Drugs
Food and Drugs
Health
Health Care
Safety
Treatment
Hide Section - MEMBERS,MEETINGS AND ADVISORY REPORTS

MEMBERS,MEETINGS AND ADVISORY REPORTS

To View all the members, meetings and advisory reports for this committee please click here
Hide Section - CHARTERS AND RELATED DOCS

CHARTERS AND RELATED DOCS

No Documents Found
Hide Section - DATA FROM PREVIOUS YEARS

DATA FROM PREVIOUS YEARS

Committee

Data from Previous Years

 
ActionCommittee System IDCommittee NameFiscal Year
 COM-040480Drug Safety and Risk Management Advisory Committee2021
 COM-038755Drug Safety and Risk Management Advisory Committee2020
 COM-036638Drug Safety and Risk Management Advisory Committee2019
 COM-034851Drug Safety and Risk Management Advisory Committee2018
 COM-001861Drug Safety and Risk Management Advisory Committee2017
 COM-002597Drug Safety and Risk Management Advisory Committee2016
 COM-004024Drug Safety and Risk Management Advisory Committee2015
 COM-004783Drug Safety and Risk Management Advisory Committee2014
 COM-006067Drug Safety and Risk Management Advisory Committee2013
 COM-006586Drug Safety and Risk Management Advisory Committee2012
 COM-008269Drug Safety and Risk Management Advisory Committee2011
 COM-008743Drug Safety and Risk Management Advisory Committee2010
 COM-010268Drug Safety and Risk Management Advisory Committee2009
 COM-010742Drug Safety and Risk Management Advisory Committee2008
 COM-012136Drug Safety and Risk Management Advisory Committee2007
 COM-012843Drug Safety and Risk Management Advisory Committee2006
 COM-014057Drug Safety and Risk Management Advisory Committee2005
 COM-014587Drug Safety and Risk Management Advisory Committee2004
 COM-015884Drug Safety and Risk Management Advisory Committee2003
 COM-016724Drug Safety and Risk Management Advisory Committee2002
 COM-017655Drug Abuse Advisory Committee2001
 COM-018355Drug Abuse Advisory Committee2000
 COM-019579Drug Abuse Advisory Committee1999
 COM-020662Drug Abuse Advisory Committee1998
 COM-021675Drug Abuse Advisory Committee1997