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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.


HHS - 871 - Bone, Reproductive and Urologic Drugs Advisory Committee - Authorized by Law
Hide Section - GENERAL INFORMATION

GENERAL INFORMATION

Committee NameBone, Reproductive and Urologic Drugs Advisory CommitteeAgency NameDepartment of Health and Human Services
Fiscal Year2020Committee Number871
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 Date3/23/2020Designated Fed Officer Position Title*Acting Designated Federal Officer
Date Of Renewal Charter3/23/2022Designated Federal Officer Prefix
Projected Termination Date Designated Federal Officer First Name*Yvette
Exempt From Renewal*NoDesignated Federal Officer Middle Name
Specific Termination AuthorityDesignated Federal Officer Last Name*Waples
Establishment Authority*Authorized by LawDesignated Federal Officer SuffixPharmD
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 CmteExempt: Consumer Product Safety CmteDesignated Federal Officer Email*brudac@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 reviews and evaluates data on the safety and effectiveness of marketed and investigational human drugs for use in the practice of osteoporosis and metabolic bone disease, obstetrics, gynecology, urology and related specialties, and makes appropriate recommendations to the Commissioner of Food and Drugs.
How is membership balanced?*Members are experts in obstetrics, gynecology, endocrinology, pediatrics, epidemiology, urology or statistics, and related specialties. The Committee also will include one technically qualified member who is identified with consumer interests and may include one non-voting representative who is identified with industry interests.
How frequent & relevant are cmte mtgs?*The Committee met twice in FY-20.

On October 29, 2019, the Committee discussed supplemental new drug application (sNDA 021945/S023) for MAKENA (hydroxyprogesterone caproate injection, 250 milligrams per milliliter) manufactured by AMAG Pharmaceuticals. In 2011, MAKENA received approval under the accelerated approval pathway (21 CFR part 314, subpart H, and section 506(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356(c)) for reducing the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. MAKENA was shown in the preapproval clinical trial (Trial 002) to reduce the proportion of women who delivered at less than 37 weeks gestation, a surrogate endpoint that FDA determined was reasonably likely to predict a clinical benefit of preterm birth prevention, such as improved neonatal mortality and morbidity. As required under 21 CFR 314.510, the Applicant conducted a post approval confirmatory clinical trial (Trial 003) to verify and describe clinical benefit. AMAG Pharmaceuticals has disclosed that this completed confirmatory trial did not demonstrate a statistically significant difference between the treatment and placebo arms for the co-primary endpoints of reducing the risk of recurrent preterm birth at less than 35 weeks gestation or improving neonatal mortality and morbidity. The committee considered the trial’s findings and the sNDA in the context of AMAG Pharmaceuticals’ confirmatory study obligation. The Committee (16 members) unanimously agreed that the findings from Trial 003 do not verify the clinical benefit of Makena on neonatal outcomes. The majority of the committee members (13 to 3) agreed that, based on the findings from Trial 002 and Trial 003, there was no substantial evidence of effectiveness of Makena in reducing the risk of recurrent preterm birth. The committee members who voted “No” based their vote on the statutory and scientific definition of “substantial evidence of effectiveness,” because Trial 003 did not substantiate the positive findings on preterm birth seen in Trial 002. Nine members voted that the FDA should pursue the withdrawl of Makena if the Applicant fails to conduct post approval trial(s) to verify clinical benefit or if such trial(s) do no verify clinical benefit. These nine members highlighted that the totality of evidence did not provide substantial evidence of effectiveness of Makena in the reducing the risk of recurrent preterm birth and that there is no evidence from Trials 002 and 003 that Makena benefits the neonate, which is the goal of treatment. Seven Members voted that FDA should leave Makena on the market under accelerated approval and require a new confirmatory trial. These seven members acknowledged the efficacy data for reducing the risk of recurrent preterm birth are conflicting and not particularly persuasive and recognized the need for more data to identify subpopulations that might benefit from Makena. Agency Action: On October 5, 2020, the Agency proposed that Makena (hydroxyprogesterone caproate injection) be withdrawn from the market because the required postmarket study failed to verify clinical benefit and we have concluded that the available evidence does not show Makena is effective for its approved use.

On October 30, 2019, the Committee discussed new drug application (NDA) 204017 (levonorgestrel and ethinyl estradiol) transdermal system, submitted by Agile Therapeutics, Inc., for the prevention of pregnancy in women of reproductive potential. The majority of the committee members (14 yeses, 1 no, 1 abstain) agreed that the benefits of this product outweigh its risks to support the drug’s approval for the prevention of pregnancy. Members who voted “Yes” noted this product’s convenience including patients who would prefer this product than a more invasive methods (e.g. long acting reversible contraceptions (LARCs) and injections) despite apparent lower efficacy. Some committee members stated that there is an unmet need for a lower dose transdermal hormonal method. member who voted "No" raised concerns about the product’s effectiveness. The member who abstained stated that the data was not focused on effectiveness and that the endpoints needed to be reassessed. Agency Action: On February 14, 2020, the Agency approved TWIRLA (levonorgestrel and ethinyl estradiol) transdermal system as a method of contraception for use in women of reproductive potential with a BMI < 30 kg/m2 for whom a combined hormonal contraceptive is appropriate.


It is expected that the Committee will meet two to three times in FY-21.
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 withstand intense public scrutiny. The alternate means of obtaining this advice would involve the recruitment of large numbers of scientists on a full-time basis at maximum rates of compensation.
Why close or partially close meetings?The Committee held no closed meetings during FY-20.
Recommendation RemarksThere were no reports required for this Committee in FY-20.
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 new medical products.
Outcome Implement Laws/Reg RequirementsYesGrants Review*No
Outcome OtherNoNumber Of Grants Reviewed0
Outcome CommentNANumber Of Grants Recommended0
Cost Savings*Unable to DetermineDollar Value Of Grants Recommended$0.00
Cost Savings CommentThe utilization of the Bone, Reproductive and Urologic 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 CommentNA
Number Of Recommendations*33Access Contact Designated Fed. Officer*Yes
Number Of Recommendations CommentThe Committee made 33 recommendations from FY-03 through FY-20. See section Recommendation/Justifications section of the ACR for specific accomplishments.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 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 Advisory Committee for Reproductive Health Drugs supports FDA's strategic priorities by reviewing and evaluating available data concerning the safety and effectiveness of marketed and investgational human drug products for use in the practice of obstetrics, gynecology, and related specialties, and makes appropriate recommendations to the Commissioner of Food and Drugs. 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*$4,360.00Est Payments to Non-Fed Members Next FY*$13,200.00
Payments to Federal Members*$0.00Est. Payments to Fed Members Next FY*$0.00
Payments to Federal Staff*$180,093.00Estimated Payments to Federal Staff*$182,185.00
Payments to Consultants*$13,080.00Est. Payments to Consultants Next FY*$5,500.00
Travel Reimb. For Non-Federal Members*$5,128.00Est Travel Reimb Non-Fed Members nextFY*$15,448.00
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*$15,796.00Est Travel Reimb to Consultants Next FY*$6,104.00
Other Costs$49,649.00Est. Other Costs Next FY*$50,218.00
Total Costs$268,106.00Est. Total Next FY*$272,655.00
Federal Staff Support (FTE)*1.10Est. Fed Staff Support Next FY*1.10
Cost RemarksEst 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-036616Bone, Reproductive and Urologic Drugs Advisory Committee2019
 COM-034829Bone, Reproductive and Urologic Drugs Advisory Committee2018
 COM-001938Bone, Reproductive and Urologic Drugs Advisory Committee2017
 COM-002315Bone, Reproductive and Urologic Drugs Advisory Committee2016
 COM-003765Bone, Reproductive and Urologic Drugs Advisory Committee2015
 COM-004427Bone, Reproductive and Urologic Drugs Advisory Committee2014
 COM-006151Advisory Committee for Reproductive Health Drugs2013
 COM-006709Advisory Committee for Reproductive Health Drugs2012
 COM-008265Advisory Committee for Reproductive Health Drugs2011
 COM-009066Advisory Committee for Reproductive Health Drugs2010
 COM-010332Advisory Committee for Reproductive Health Drugs2009
 COM-010861Advisory Committee for Reproductive Health Drugs2008
 COM-011878Advisory Committee for Reproductive Health Drugs2007
 COM-012610Advisory Committee for Reproductive Health Drugs2006
 COM-014003Advisory Committee for Reproductive Health Drugs2005
 COM-014721Advisory Committee for Reproductive Health Drugs2004
 COM-015932Advisory Committee for Reproductive Health Drugs2003
 COM-016506Advisory Committee for Reproductive Health Drugs2002
 COM-017997Advisory Committee for Reproductive Health Drugs2001
 COM-018712Advisory Committee for Reproductive Health Drugs2000
 COM-019748Advisory Committee for Reproductive Health Drugs1999
 COM-020361Advisory Committee for Reproductive Health Drugs1998
 COM-021423Advisory Committee for Reproductive Health Drugs1997