FACA

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

GENERAL INFORMATION

Committee Name	Drug Safety and Risk Management Advisory Committee	Agency Name	Department of Health and Human Services
Fiscal Year	2021	Committee Number	847
Original Establishment Date	11/28/1990	Committee Status	Chartered
Actual Termination Date		Committee URL	http://www.fda.gov/AdvisoryCommittees/Committee...
New Committee This FY	No	Presidential Appointments*	No
Terminated This FY	No	Max Number of Members*	12
Current Charter Date	5/31/2020	Designated Fed Officer Position Title*	Designated Federal Officer
Date Of Renewal Charter	5/31/2022	Designated Federal Officer Prefix
Projected Termination Date		Designated Federal Officer First Name*	Philip
Exempt From Renewal*	No	Designated Federal Officer Middle Name	A.
Specific Termination Authority		Designated Federal Officer Last Name*	Bautista
Establishment Authority*	Authorized by Law	Designated Federal Officer Suffix	Pharm.D.
Specific Establishment Authority*	21 U.S.C. 394	Designated Federal Officer Phone*	(301) 796-9001
Effective Date Of Authority*	11/28/1990	Designated Federal Officer Fax*	301-847-8533
Exempt From EO 13875 Discretionary Cmte	Exempt: Consumer Product Safety Cmte	Designated Federal Officer Email*	philip.bautista@fda.hhs.gov
Committee Type*	Continuing
Presidential*	No
Committee Function*	Scientific Technical Program Advisory Board

RECOMMENDATION/JUSTIFICATIONS

Agency Recommendation*	Continue
Legislation to Terminate Required	Not Applicable
Legislation Status	Not 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-20, the Committee met three times. At two 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 January 14, 2020, 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. During the morning of January 15, 2020, 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. During the afternoon of January 15, 2020, 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 September 10-11, 2020, the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee met jointly to discuss the results of required postmarketing studies (Postmarketing Requirements 3051-1, 3051-2, 3051-3, and 3051-4) that evaluated the effect of the reformulation of OXYCONTIN (oxycodone hydrochloride extended-release tablets, manufactured by Purdue Pharma L.P., NDA 022272) on abuse, misuse, and fatal and non-fatal overdose, associated with OXYCONTIN. The Committees discussed whether these studies, in concert with other information from the published literature, have demonstrated that the reformulated OXYCONTIN product has resulted in a meaningful reduction in these outcomes. The Committees also discussed the broader public health impact of OXYCONTIN’s reformulation. The majority of th members (20 to 7) voted “Yes”, agreeing that the available evidence demonstrate that the reformulation of OxyContin meaningfully reduced abuse of the product, relative to the original formulation, by one or more non-oral routes. A majority of the members ( 2 to 26) voted “No”, that the available evidence does not demonstrate that the reformulation of OxyContin meaningfully reduced overall abuse of this product, relative to the original formulation. There was no consensus among these members as to whether there was sufficient evidence or whether additional information is still needed. The majority of the committee members (1 to 26) voted “No”, that the available evidence does not demonstrate that OxyContin’s reformulation meaningfully reduced the risk of opioid overdose, relative to the original formulation. It is expected that the Committee will meet six to seven 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-20.
Recommendation Remarks	There were no reports required for this Committee in FY-20. In FY-20, the Committee met three times. At two of these meetings, the Drug Safety and Risk Management Advisory Committee, met in joint session with other committees but was not the lead Committee. So that joint meetings are not counted twice in the FACA database, they will be reported under the primary or lead Committee. For the purposes of this database, the secondary Committee still reports meeting information and costs associated under this section of the report as well as the cost section. On January 14, 2020, the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee met jointly to discuss new drug application 211802 for oxycodegol, a new molecular entity full mu-opioid receptor agonist, submitted by Nektar Therapeutics, for the management of chronic low back pain in adult patients with pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The Committees were asked to discuss the safety and efficacy data as well as the overall risk-benefit profile of the product. The Committees voted unanimously against (27 to 0) the approval of oxycodegol due to deficiencies in the presented data. Many members felt that the potential benefits of this product did not outweigh its risks. Many were also concerned that, if this drug was approved, it could set a precedent for approval on just one efficacy study. During the morning session on January 15, 2020, During the morning session, 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) 213426, for tramadol 44 milligrams (mg) and celecoxib 56 mg tablet, which contains a fixeddose combination of an opioid and a non-steroid anti-inflammatory drug, submitted by Esteve Pharmaceuticals, S.A., for the management of acute pain in adults that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate. The Committees were asked to discuss the safety and efficacy data as well as the overall risk-benefit profile of the product. The members were split (13 to 13) on whether they recommend approval of tramadol 44mg and celecoxib 56mg tablets for the proposed indication of the management of acute pain in adults that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate. During the afternoon session on January 15, 2020, During the morning session, the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee met jointly to discuss NDA 209653, for an extended-release oral tablet formulation of oxycodone, submitted by Intellipharmaceutics Corp., with the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. The product has been formulated with properties intended to deter abuse, and the applicant has submitted data to support these abuse-deterrent properties for this product. The Committees were asked to discuss whether the applicant has demonstrated abuse-deterrent properties for their product that would support labeling, as well as to discuss the overall risk-benefit profile of the product. An overwhelming majority of the members(2 yeses to 24 noes) voted “No”, indicating that they did not recommend approval of AXIMRIS XR (oxycodone extended-release tablets) for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. These members agreed that AXIMRIS XR did not offer any abuse-deterrent advantages to what is currently available on the market and added that it offered more disadvantages such as the issues involving abuse via the intranasal route. Although the current charter states that the committee shall hold meetings approximately five 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.

PERFORMANCE MEASURES

Outcome Improvement To Health Or Safety*	Yes	Action Reorganize Priorities*	Yes
Outcome Trust In Government	Yes	Action Reallocate Resources	Yes
Outcome Major Policy Changes	Yes	Action Issued New Regulations	Yes
Outcome Advance In Scientific Research	Yes	Action Proposed Legislation	Yes
Outcome Effective Grant Making	No	Action Approved Grants Or Other Payments	No
Outcome Improved Service Delivery	No	Action Other	Yes
Outcome Increased Customer Satisfaction	Yes	Action Comment	FDA approves or chooses not to approve an investigational new medical product.
Outcome Implement Laws/Reg Requirements	Yes	Grants Review*	No
Outcome Other	No	Number Of Grants Reviewed	0
Outcome Comment	N/A	Number Of Grants Recommended	0
Cost Savings*	Unable to Determine	Dollar Value Of Grants Recommended	$0.00
Cost Savings Comment	The 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 Comment	N/A
Number Of Recommendations*	69	Access Contact Designated Fed. Officer*	Yes
Number Of Recommendations Comment	The Committee made 69 recommendations from FY-03 through FY-20. See section Recommendation/Justifications of the ACR for specific accomplishments.	Access Agency Website	Yes
% of Recs Fully Implemented*	84.00%	Access Committee Website	Yes
% of Recs Fully Implemented Comment	The 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 Website	Yes
% of Recs Partially Implemented*	10.00%	Access Publications	Yes
% of Recs Partially Implemented Comment	The 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 Other	No
Agency Feedback*	Yes	Access Comment	N/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.	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.

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	$0.00	Est. Total Next FY*	$0.00
Federal Staff Support (FTE)*		Est. Fed Staff Support Next FY*
Cost Remarks		Est Cost Remarks

Interest Areas

Category Area Food and Drugs Food and Drugs Health Health Care Safety Treatment

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