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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 Year2018Committee 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-18, the committee held seven (7) meeting. At six (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 October 31, 2017, 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 1, 2017, a meeting was held jointly with the Psychopharmacologic Drugs Advisory Committee. Further information regarding this meeting is provided in the Recommendation Remarks section.

On February 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 April 24-25, 2018, a meeting was held jointly with the Arthritis Advisory Committee. Further information regarding this meeting is provided in the Recommendation Remarks section.

On May 22, 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 June 26, 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 August 3, 2018, the Drug Safety and Risk Management Advisory Committee met jointly with the Anesthetic and Analgesic Drug Products Advisory Committee to discuss results from assessments of the transmucosal immediate-release fentanyl (TIRF) medicines’ risk evaluation and mitigation strategy (REMS), approved in December 2011. The TIRF REMS requires that healthcare providers who prescribe TIRF medicines for outpatient use are specially certified, that pharmacies that dispense TIRF medicines for inpatient and outpatient use are specially certified, and that completion of the prescriber-patient agreement form occurs prior to dispensing TIRF medicines for outpatient use. The Agency sought the committees’ assessment as to whether this REMS with elements to assure safe use (ETASU) assures safe use, is not unduly burdensome to patient access to the drugs, and to the extent practicable, minimizes the burden to the healthcare delivery system. The Agency will also sought the committees’ input on any possible modifications to the TIRF REMS goals and requirements, as well as input on the adequacy of the evaluations conducted in the REMS assessments to determine whether the TIRF REMS goals are being met. 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-19.
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?During FY-18, the committee held one (1) partially closed meeting jointly with another committee but was not the lead committee. On June 26, 2018, from 8 a.m. to 9:30 a.m., the joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee was closed to permit discussion and review of trade secret and/or confidential commercial information (5 U.S.C. 552b(c)(4)). During this session, the committees discussed the drug development program of an investigational opioid formulation with properties designed to deter abuse.
Recommendation RemarksIn FY-18, the committee held seven (7) meeting. At six (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 October 31, 2017, the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee met jointly to discuss new drug application (NDA) 209819, Sublocade (buprenorphine subcutaneous injection), submitted by Indivior Pharmaceuticals, Inc., for treatment of opioid dependence. Overall, the majority of the committee (18 to 1) agreed that the benefit and safety profile of buprenorphine was favorable for approval. The committee member voting “No”, expressed concerns over need for more data for safety. Regarding safety, the majority of the committee members (13 to 6) agreed that the safety data sufficiently supported the use of the proposed RBP 300 mg/300 mg dose regimen, even though the steady-state plasma exposures associated with RBP-6000 300 mg exceed those associated with the highest labeled dose of the reference product, Subutex. Those voting “Yes”, stated that it is necessary in clinical practice to go up on the dose of buprenorphine for effectiveness; the higher dose is needed for some patients with more severe opioid use disorders. Those committee members voting “No”, expressed concerns that they were unconvinced completely about the higher dose's added efficacy; they need to see more clinical safety data for the highest dose; and more toxicology studies are warranted. Most the committee members agreed that both the RBP-6000 300/300 mg and 300/100 mg regimen are efficacious. Committee members stated they mostly see no significant difference in the doses with respect to efficacy given that there is no good evidence against it. The members further stated that the higher doses should include liver function monitoring. Most the committee members agreed with the need for the FDA proposed addition to the applicant's proposed REMS to include a one-time certification of health care settings that order and dispense RBP-6000 to put systems in place from being dispensed directly to the patient. Agency Action: The Agency is still reviewing all recommendations that were made at the meeting.

On November 1, 2017, the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee met jointly to discuss new drug application (NDA) 210136, buprenorphine subcutaneous injection, submitted by Braeburn Pharmaceuticals, Inc., for treatment of opioid dependence. The majority of the committee members (17 members) recommended approval for some of the proposed doses. The committee members voting “C” (3 members) expressed concerns over the trial design being problematic, and limited clinical data. The majority of the committee members (17 members) voted that the data from the clinical trial, taken together with the blockade study, provide substantial evidence of effectiveness of CAM2038 weekly and monthly formulations for the treatment of opioid use disorder in patients who are newly initiating buprenorphine treatment for some of the doses. Most of the committee members agreed that unsafe side effects were not observed with CAM2038. A few members commented that the clinical trial design mimics real world practice and is reflective of an effectiveness rather than efficacy trial, which should predict its success in treating opioid use disorders. However, other members disagreed and commented that the inherent design of the clinical trial, which did not allow for the collection of highly controlled data to predict the safety and efficacy of the CAM2038 doses investigated, was disappointing and a drawback. The majority of the committee members agreed and supported the need for the FDA's proposed addition to the REMS to include a one-time certification of health care settings that order and dispense CAM2038 to put systems in place from being dispensed directly to the patient. Some members commented that it may be too difficult to implement the REMS from a policy standpoint because of differences in State laws. The members also noted that the need for community pharmacists to be aware of patients use of CAM2038 via sharing of medication lists. Agency Action: The Agency is still reviewing all recommendations that were made at the meeting. On, February 14, 2018, the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee met jointly to discuss new drug application (NDA) 209257, proposed tradename, HYDEXOR, a fixed-dose combination oral tablet, submitted by Charleston Laboratories, Inc., that contains hydrocodone, acetaminophen, and promethazine, for the short-term management of acute pain severe enough to require an opioid analgesic while preventing and reducing opioid-induced nausea and vomiting. The committees discussed the abuse potential of this non-abuse-deterrent product and whether it should be approved. Agency Action: The Agency is still reviewing all recommendations that were made at the meeting.

On February 14, 2018, the Anesthetic and Analgesic Drug Products Advisory Committee met jointly with the Drug Safety and Risk Management Advisory Committee to discuss new drug application (NDA) 209257, proposed tradename, HYDEXOR, a fixed-dose combination oral tablet, submitted by Charleston Laboratories, Inc., that contains hydrocodone, acetaminophen, and promethazine, for the shortterm management of acute pain severe enough to require an opioid analgesic while preventing and reducing opioid-induced nausea and vomiting. The committees were also asked to discuss the abuse potential of this non-abuse-deterrent product and whether it should be approved. The majority of the committee (19 to 2) agreed that Hydexor should not be approved. Some of the committee members who voted “No” stated that their vote was based on the lack of dosing flexibility and that the ramifications of the risks associated with Hydexor did not outweigh its benefit. Overall, the majority of the committee agreed that Hydexor poses greater risks than currently marketed hydrocodone-acetaminophen products. Some committee members added that an antiemetic may not be needed for every dose of analgesic, and that a fixed-dose combination of Hydexor would expose patients to unnecessary side effects of promethazine when it is not needed. Other committee members agreed that the applicant’s proposed risk mitigation strategies are not convincing. One committee member who voted “Yes” viewed Hydexor as another opioid option and noted that its risks are no greater than what is currently on the market. Additionally, this member noted that that the population receiving Hydexor would be those who were prone to OINV and that the medication would be taken as needed. The other committee member who voted “Yes” stated that the overall benefits outweighed the risks but also suggested that toxicity data of promethazine when patients took more than six pills a day is needed. Agency Action: The Agency is still reviewing all recommendations that were made at the meeting.

On April 24-25, 2018, the Arthritis Advisory Committee met jointly with the Drug Safety and Risk Management Advisory Committee to discuss supplemental new drug application (sNDA) 20998 for CELEBREX (celecoxib) capsules submitted by Pfizer, Inc., which includes the results from the PRECISION (Prospective Randomized Evaluation of Celecoxib Integrated Safety vs. Ibuprofen Or Naproxen) trial, a cardiovascular outcomes randomized controlled trial that compared celecoxib to ibuprofen and naproxen, and determine whether the findings of the trial change FDA’s current understanding of the safety of these three NSAIDs. In order to interpret some of the PRECISION findings, the committees also considered the clinical implications of the drug interactions between each of these three NSAIDs and aspirin in patients taking aspirin for secondary prevention of cardiovascular disease. The majority of the committee (12 members) agreed that the Drug Facts label should include a warning regarding the interaction between aspirin and naproxen. These members mentioned the need for consistency between the OTC Drug Facts label of naproxen and that of ibuprofen. The majority of the committee members (17 members) also agreed that there should be no change to the current ibuprofen Drug Facts label. These members noted that there was no new information or data presented to warrant a change to the current label. Agency Action: The Agency is currently reviewing all recommendations that were made during the meeting.

On May 22, 2018, the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee met jointly to discuss new drug application (NDA) 209588, for buprenorphine sublingual spray, submitted by INSYS Development Company, Inc., for the treatment of moderate-to-severe acute pain where the use of an opioid analgesic is appropriate. The committees were also asked to discuss whether this product should be approved. The majority of the committee (18 to 1) voted “No”, that the benefits of Buvaya do not outweigh the risks for the indication, “the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate,” supporting approval of Buvaya. These members also agreed that although a commendable effort was made by the applicant to introduce an innovative product that may be less likely to be abused than some schedule II opioid analgesics, the factors contributing to their vote were the late onset of analgesia, and high rate of adverse events (primarily hypoxia). The committee member who voted “Yes” explained that the low abuse potential and the lack of alternative treatments available in the market were factors considered in the vote. Agency Action: The Agency is still reviewing all recommendations that were made at the meeting.

On June 26, 2018, the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee met jointly to discuss new drug application 022324, oxycodone extended-release capsules, submitted by Pain Therapeutics, with the proposed indication of the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The product is intended to have abuse-deterrent properties based on its physicochemical properties. The committees were also asked to discuss whether the data submitted by the Applicant are sufficient to support labeling of the product with the properties expected to deter abuse. The majority of the panel members (14 to 3) voted “No”, that the efficacy, safety and risk-benefit profile of Remoxy ER do not support the approval of this application. The committee members largely agreed that the public health risks of approving this reformulation of oxycodone does not outweigh its benefits. Other comments included that approving Remoxy ER with an abuse deterrent label may create a false sense of safety for this formulation and that the benefits of its nasal deterrence properties are not enough to justify approval with abuse deterrent labeling. Panelists voting “No” largely agreed that Remoxy ER did not demonstrate enough abuse deterrent properties via the oral and IV routes of administration. Of the committee members who voted “Yes,” the key comments were that the Applicant had met the standard for safety and efficacy and also met the criteria for abuse deterrence via the nasal and IV routes. Agency Action: The Agency is still reviewing all recommendations that were made at the meeting.

This committee is expected to meet 5-6 times in FY-19.
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*56Access Contact Designated Fed. Officer*Yes
Number Of Recommendations CommentThe committee made 56 recommendations from FY-03 through FY-18. 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*$21,477.00Est Payments to Non-Fed Members Next FY*$52,497.00
Payments to Federal Members*$0.00Est. Payments to Fed Members Next FY*$0.00
Payments to Federal Staff*$172,271.00Estimated Payments to Federal Staff*$174,886.00
Payments to Consultants*$16,239.00Est. Payments to Consultants Next FY*$16,405.00
Travel Reimb. For Non-Federal Members*$32,211.00Est Travel Reimb Non-Fed Members nextFY*$75,744.00
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*$23,219.00Est Travel Reimb to Consultants Next FY*$18,895.00
Other Costs$58,529.00Est. Other Costs Next FY*$59,340.00
Total Costs$323,946.00Est. Total Next FY*$397,767.00
Federal Staff Support (FTE)*1.10Est. Fed Staff Support Next FY*1.10
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-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