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Committee Detail

Hide Section - GENERAL INFORMATION

GENERAL INFORMATION

Committee NameDrug Safety and Risk Management Advisory CommitteeAgency NameDepartment of Health and Human Services
Fiscal Year2019Committee 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 Date5/31/2018Designated Fed Officer Position Title*Designated Federal Officer
Date Of Renewal Charter5/31/2020Designated 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
Committee Type*ContinuingDesignated Federal Officer Email*philip.bautista@fda.hhs.gov
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-19, the committee held 7 meetings. At 6 of these meetings, the Drug Safety and Risk Management Advisory Committee, met in joint session with other committees but was not the lead committee. See the Agency Recommendations, Remarks section for a list of joint meetings in which the committee was not the lead committee.

On November 1, 2018, a meeting was held jointly with the Psychopharmacologic Drugs Advisory Committee. Further information regarding this meeting is provided in the Recommendation Remarks section.

On November 2, 2018, a meeting was held jointly with the Psychopharmacologic Drugs Advisory Committee. Further information regarding this meeting is provided in the Recommendation Remarks section.

On November 14, 2018, a meeting was held jointly with the Anesthetic and Analgesic Drug Products Advisory Committee. Further information regarding this meeting is provided in the Recommendation Remarks section.

On December 17-18, 2018, a meeting was held jointly with the Anesthetic and Analgesic Drug Products Advisory Committee. Further information regarding this meeting is provided in the Recommendation Remarks section.

On January 11, 2019, a meeting was held jointly with the Arthritis Advisory Committee. Further information regarding this meeting is provided in the Recommendation Remarks section.

On February 12, 2019, a meeting was held jointly with the Psychopharmacologic Drugs Advisory Committee. Further information regarding this meeting is provided in the Recommendation Remarks section.

On June 11-12, 2019, the Drug Safety and Risk Management Advisory Committee met jointly with the Anesthetic and Analgesic Drug Products Advisory Committee to discuss: (1) The current clinical use and situations that may warrant pain management with opioid analgesics at higher product strengths and daily doses, factors influencing prescribing practices, and specific patient populations for whom there may be utility in prescribing these medications at higher doses; (2) the magnitude and frequency of harms associated with opioid analgesics at higher product strengths and daily doses, relative to lower strengths and daily doses, including the role of opioid dose in adverse health outcomes in both patients and in others who may access the drugs (e.g., risk for developing addiction, fatal overdose), the relevance of therapy duration and physical opioid dependence, and risks in different subpopulations (e.g., patients with chronic non-cancer pain, young children, adolescents); and (3) possible FDA interventions and their expected impact on patients and public health more broadly, including, for example, potential effects on prescribing and pain management practices, patient experience and behaviors, and adverse outcomes such as addiction and overdose. The majority of members agreed that patient populations who may require higher daily doses would be end of life, hospice or palliative care as well as those with debilitating illnesses, such as cancer and complex neurological and musculoskeletal conditions and that higher doses might reduce pain and improve mobility and quality of life in these populations. The majority of the comembers agreed that there is a clinical need for higher dosage strength opioid analgesic products, especially for reducing pill burden and difficulty of swallowing. However, members also agreed that the risk of an increased number of deaths from overdose on higher dosage strength opioid outweighs the inconvenience from swallowing more pills. The majority of the committee members agreed that there are greater risks associated with higher daily doses and higher dosage strength opioid analgesic products relative to lower daily doses and lower dosage strength products. Overall, the committee members agree that caution should be taken with any regulatory action intended to target or reduce prescribing and use of higher dosage strength opioid analgesic products, as it may be very destabilizing to patients who have a clinical need for higher dosage strengths, as the data show that this is a vulnerable population. The committee noted the potential negative impacts on patient health and public health might include inconvenience (e.g. more pills for patients and difficulties with insurance coverage), issues with swallowing a high number of pills, and increased potential for medication errors and diversion due to a higher volume of pills. Agency Action: The Agency is still reviewing all recommendations that were made at the meeting.


It is expected that the committee will meet four to six times in FY-20.
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-19.
Recommendation RemarksThere were no reports required for this committee.

In FY-19, the committee held 7 meetings. At 6 of these meetings, the Drug Safety and Risk Management Advisory Committee, met in joint session with other committees but was not the lead committee.

On November 1, 2018, a meeting was held jointly with the Psychopharmacologic Drugs Advisory Committee to discuss the efficacy, safety and risk-benefit profile of new drug application (NDA) 210417 for buprenorphine and samidorphan sublingual tablets, submitted by Alkermes, Inc., for adjunctive treatment of major depressive disorder. The majority of members (21 to 2) agreed that the available data do not support a favorable benefit-risk profile of this product to support approval. A slight majority of members (13 to 10) agreed that the safety profile of the product was well characterized and stated that there were minimal withdrawal effects and abuse liability. The members who did not agree stated their concerns with potential tampering to separate buprenorphine; the risk of diversion, abuse, and overdose; and the link between major depressive disorder and pain and addictive disorders. Overall, the committee agreed that studies (1) need to be adequately powered to measure the small effect, (2) are needed to clarify what specific patient would most benefit from this product, and (3) are needed to quantify the effects of opioid withdraw with this medication. Agency Action: The Agency is still reviewing all recommendations that were made at the meeting.

On November 2, 2018, a meeting was held jointly with the Psychopharmacologic Drugs Advisory Committee to discuss the efficacy, safety, and benefit-risk profile of new drug application (NDA) 211371, brexanolone 5 mg/mL intravenous injection, submitted by Sage Therapeutics, for the proposed indication of postpartum depression. The majority of the committee (17 to 1) agreed that the benefits outweigh the risks of brexanolone for the treatment of postpartum depression when used in a certified facility by qualified staff as outlined in the FDA’s proposed REMS. These members agreed that the loss of consciousness events are well characterized and can be addressed through a strong REMS. However, the committee members were conflicted on dosing strategy. Agency Action: On March 19, 2019, the Agency approved Zulresso (brexanolone) injection for intravenous (IV) use for the treatment of postpartum depression (PPD) in adult women.

On November 14, 2018, a meeting was held jointly with the Anesthetic and Analgesic Drug Products Advisory Committee to discuss new drug application (NDA) 209774, for an immediate-release oral tablet formulation of oxycodone, which is intended to resist common methods of physical or chemical manipulation and to deter intravenous and intranasal abuse, submitted by SpecGx LLC, for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. The committees were also asked to determine whether the Applicant adequately demonstrated that the abuse-deterrent properties of the proposed product are sufficient to include this information in the product label, and whether the product should be approved. The majority of members (10 to 7) agreed that oxycodone hydrochloride immediate-release tablets (MNK-812) should be approved for the proposed indication. Some of the committee members who supported approval based their decisions on the demonstration of bioequivalence to the comparator oxycodone hydrochloride immediate-release product and concluded that oxycodone hydrochloride immediate-release tablets (MNK-812) represents an abuse-deterrent option relative to existing non-ADF immediate-release oxycodone formulations. The committee members who voted “No” concluded that this product would provide minimal benefit over risk and expressed concern that it may provide a false sense of security to prescribers. The majority of members (12 to 5) agreed that if approved, this product should be labelled as an abuse-deterrent product by the nasal route of abuse. The majority of members (10 to 7) did not agree that the product should be labeled as an abuse-deterrent product by the intravenous route. Agency Action: The Agency is still reviewing all recommendations that were made at the meeting.

On December 17-18, 2018, a meeting was held jointly with the Anesthetic and Analgesic Drug Products Advisory Committee at which the committees provided input and advice on strategies to increase the availability of naloxone products intended for use in the community. The committees were asked to consider various options for increasing access to naloxone, weighing logistical, economic, and harm reduction aspects and whether naloxone should be co-prescribed with all or some opioid prescriptions to reduce the risk of overdose death. Because of the potential, significant costs and burdens that may be associated with naloxone co-prescribing (e.g., economic costs to consumers and health systems, adjusting to manufacturing volume growth, drug shortages), the committees were also asked to consider the potential burdens that may be associated with naloxone co-prescribing for all or some prescription opioid patients. The members agreed that the FDA efforts should include facilitating more rapid availability of over-the-counter (OTC) naloxone and generic naloxone products, and considering using Departmental authorities to enhance the distribution of naloxone by the federal government. The committees discussed that the major burden to co-prescribing naloxone is cost, which includes cost to the patient, the healthcare system, and secondary costs. It was noted that secondary burdens are also the failure to address the larger public health issue of increasing illicit opioid deaths and the stigma of revealing a need for naloxone to a healthcare provider. The committees stated that targeting high-risk populations is a problem because it is difficult to define what constitutes a high-risk population; this approach may require a separate situational targeting model. A slim majority of members (12 to 11) voted “Yes” that labeling language that recommends co-prescription of naloxone for all or some patients prescribed opioids, or more targeted prescribing for patients otherwise at high risk for death from opioid overdose, would be an effective method for expanding access to naloxone and improving public health. Many committee members who voted “Yes” stated that while labeling may be an effective strategy to expand access to naloxone, it would not be the most effective strategy. Agency Action: The Agency is still reviewing all recommendations that were made at the meeting.

On January 11, 2019, a meeting was held jointly with the Arthritis Advisory Committee to discuss supplemental new drug application (sNDA) 021-856, ULORIC (febuxostat) tablets, sponsored by Takeda Pharmaceuticals, which includes the results from the postmarketing safety trial required by FDA to evaluate the cardiovascular safety of febuxostat, entitled “Cardiovascular Safety of Febuxostat and Allopurinol in Patients with Gout and Cardiovascular Morbidities (CARES).” Febuxostat is a xanthine oxidase inhibitor indicated for the chronic management of hyperuricemia in patients with gout. The committee’s discussion included the results from the CARES trial, the benefit risk assessment of febuxostat, and potential regulatory actions. The majority of members (19 to 2) agreed that there is a patient population in which the benefit-risk profile for febuxostat is favorable for the treatment of hyperuricemia in patients with gout. These members noted that there is a subgroup of gout patients who have failed or could not tolerate allopurinol, in which the benefit outweighs the risk for febuxostat. The committee members suggested the following: stronger labels, boxed warning, second-line therapy in indication, update to the gout treatment guidelines by the American College of Rheumatology (ACR), and “Dear Healthcare Provider” letters to communicate the risk to patients and their providers so they can make an informed decision on the care plan. The committee members who voted “No” noted that there is clear evidence that febuxostat caused cardiovascular death, thus withdrawal is the next option in the absence of a REMS. The committee member who abstained noted that the question is ambiguous. Agency Action: On February 21, 2019, the Agency concluded there is an increased risk of death with Uloric (febuxostat) compared to another gout medicine, allopurinol and updated the Uloric prescribing information to require a Boxed Warning, our most prominent warning, and a new patient Medication Guide. The Agency also limited the approved use of Uloric to certain patients who are not treated effectively or experience severe side effects with allopurinol.

On February 12, 2019, a meeting was held jointly with the Psychopharmacologic Drugs Advisory Committee to discuss the efficacy, safety and risk-benefit profile of new drug application 211243, esketamine 28 mg single-use nasal spray device, submitted by Janssen Pharmaceuticals, Inc., for the treatment of treatment-resistant depression. The majority of members (14 to 2 with 1 abstention) agreed that benefits of esketamine outweigh the risks given its effectiveness and safety and the FDA’s proposed risk evaluation and mitigation strategy. The 2 members who voted “No” did not agree that the evidence support efficacy and safety were adequate and had concerns regarding death and long-term use. The member who abstained had concerns regarding the magnitude of benefit. Agency Action: On March 5, 2019, the Agency approved Spravato (esketamine) nasal spray, in conjunction with an oral antidepressant, for the treatment of depression in adults who have tried other antidepressant medicines but have not benefited from them (treatment-resistant depression).
Hide Section - PERFORMANCE MEASURES

PERFORMANCE MEASURES

Outcome Improvement To Health Or Safety*YesAction Reorganize Priorities*Yes
Outcome Trust In GovernmentYesAction Reallocate ResourcesNo
Outcome Major Policy ChangesYesAction Issued New RegulationsYes
Outcome Advance In Scientific ResearchYesAction Proposed LegislationNo
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*63Access Contact Designated Fed. Officer*Yes
Number Of Recommendations CommentThe committee made 63 recommendations from FY-03 through FY-19. See question 20a of the annual report for specific accomplishments.Access Agency WebsiteYes
% of Recs Fully Implemented*80.00%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, and therefore, the Agency has the option of not implementing the advice.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 CommentIt usually does. Product approval issues are first released to the sponsor. When appropriate, information is made available to the public. Actions related to guidance documents or other general matters issues are available publicly when implemented.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* Est Payments to Non-Fed Members Next FY* 
Payments to Federal Members* Est. Payments to Fed Members Next FY* 
Payments to Federal Staff* Estimated Payments to Federal Staff* 
Payments to Consultants* Est. Payments to Consultants Next FY* 
Travel Reimb. For Non-Federal Members* Est Travel Reimb Non-Fed Members nextFY* 
Travel Reimb. For Federal Members* Est Travel Reimb For Fed Members* 
Travel Reimb. For Federal Staff* Est. Travel Reimb to Fed Staff Next FY* 
Travel Reimb. For Consultants* Est Travel Reimb to Consultants Next FY* 
Other Costs Est. Other Costs Next FY* 
Total Costs$0.00Est. Total Next FY*$0.00
Federal Staff Support (FTE)* Est. Fed Staff Support Next FY* 
Hide Section - Custom Links

Custom Links

     Committee Level Reports               
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

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Hide Section - DATA FROM PREVIOUS YEARS

DATA FROM PREVIOUS YEARS

Committee

Data from Previous Years

 
ActionCommittee System IDCommittee NameFiscal Year
 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
 COM-034851Drug Safety and Risk Management Advisory Committee2018