Clinical Utility of Treating Patients with Compounded “Bioidentical Hormone Replacement Therapy”

Workshop

Report Release Webinar: The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of the Safety, Effectiveness, and Use

July 1, 2020

11:00 AM - 12:15 PM (ET)

Past

Materials

Public Release PowerPoint Presentation

About

The National Academies of Sciences, Engineering, and Medicine Committee on The Clinical Utility of Treating Patients with Compounded “Bioidentical Hormone Replacement Therapy” a public briefing to review the conclusions and recommendations from the report.

Additional Information

Is it a Closed Session event?

Not Closed

Contact

Contact us

Disclaimer

It is essential to the National Academies mission of providing evidence-based advice that participants in any of our meetings or events avoid political or partisan statements or commentary and maintain a culture of mutual respect. The statements and presentations during our meetings or events are solely those of the individual participants and do not necessarily represent the views of other participants or the National Academy of Sciences, which is a non-partisan, tax exempt organization that includes under its Charter the National Academy of Engineering and National Academy of Medicine, and that operates the National Research Council.

Meeting Closed

Clinical Utility of Treating Patients with Compounded “Bioidentical Hormone Replacement Therapy” Meeting 8

April 24, 2020

1:00 PM - 5:00 PM (ET)

Past

About

A virtual half-day meeting of the Committee on the Clinical Utility of Treating Patients with Compounded “Bioidentical Hormone Replacement Therapy”

Additional Information

Is it a Closed Session event?

Institution Closed

Contact

Contact us

Disclaimer

It is essential to the National Academies mission of providing evidence-based advice that participants in any of our meetings or events avoid political or partisan statements or commentary and maintain a culture of mutual respect. The statements and presentations during our meetings or events are solely those of the individual participants and do not necessarily represent the views of other participants or the National Academy of Sciences, which is a non-partisan, tax exempt organization that includes under its Charter the National Academy of Engineering and National Academy of Medicine, and that operates the National Research Council.

Meeting Closed

Clinical Utility of Treating Patients with Compounded “Bioidentical Hormone Replacement Therapy” - Meeting 7

January 27, 2020

1:00 PM - 5:00 PM (ET)

Past

About

A virtual half-day meeting of the Committee on the Clinical Utility of Treating Patients with Compounded “Bioidentical Hormone Replacement Therapy”

Additional Information

Is it a Closed Session event?

Institution Closed

The following committee members were present at the closed sessions of the event

Ruth Parker (virtual)
Robert MacArthur (virtual)
Susan S. Ellenberg (virtual)
Jose Manautou (virtual)
Lesley H. Curtis (virtual)
Nancy Reame (virtual)
Rulla Tamimi (virtual)
Jennifer Fishman (virtual)
Donald Mattison (virtual)
Aaron Kesselheim (virtual)
Adel Karara (virtual)
David Rubinow (virtual)

The following topics were discussed in the closed sessions:

The statement of task
Drafts of the report

Date of posting of Closed Session Summary:

January 31, 2020

Contact

Contact us

Disclaimer

It is essential to the National Academies mission of providing evidence-based advice that participants in any of our meetings or events avoid political or partisan statements or commentary and maintain a culture of mutual respect. The statements and presentations during our meetings or events are solely those of the individual participants and do not necessarily represent the views of other participants or the National Academy of Sciences, which is a non-partisan, tax exempt organization that includes under its Charter the National Academy of Engineering and National Academy of Medicine, and that operates the National Research Council.

Meeting

Clinical Utility of Treating Patients with Compounded “Bioidentical Hormone Replacement Therapy” - Virtual Call with Compounding Representatives

January 14, 2020

12:00 PM - 2:00 PM (ET)

Past

Materials

About

The Committee on the Clinical Utility of Treating Patients with Compounded “Bioidentical Hormone Replacement Therapy” will host a virtual meeting with invited speakers from several compounding facilities.

Additional Information

Is it a Closed Session event?

Not Closed

Contact

Contact us

Disclaimer

It is essential to the National Academies mission of providing evidence-based advice that participants in any of our meetings or events avoid political or partisan statements or commentary and maintain a culture of mutual respect. The statements and presentations during our meetings or events are solely those of the individual participants and do not necessarily represent the views of other participants or the National Academy of Sciences, which is a non-partisan, tax exempt organization that includes under its Charter the National Academy of Engineering and National Academy of Medicine, and that operates the National Research Council.

Meeting

Clinical Utility of Treating Patients with Compounded “Bioidentical Hormone Replacement Therapy” - Meeting 6

November 12 - 14, 2019

Past

Materials

About

The National Academies of Sciences, Engineering, and Medicine is hosting an open session meeting for the Committee on Clinical Utility of Treating Patients with Compounded "Bioidentical Hormone Replacement Therapy”. The open session will be held on November 12th, 2019 from 1:00pm to 5:00pm (ET) at the Keck Building at 500 5th St. NW, Washington, DC 20001. In-person seating will be very limited, but a virtual webcast will also be available for those wishing to participate.

This meeting will provide an opportunity for the committee to gather data and context information from relevant subject matter experts. There will also be a short Q&A session with the viewing public.

A recording of the meeting can now be viewed here.

Additional Information

Is it a Closed Session event?

Partially Closed

The following committee members were present at the closed sessions of the event

Lesley H. Curtis
Susan S. Ellenberg
Nancy Reame
Rulla Tamimi (virtual)
Robert Macarthur
Jose Manautou
Jennifer Fishman
Ruth Parker
Donald Mattison
David Rubinow (virtual)
Adel Karara
Aaron Kesselheim

The following topics were discussed in the closed sessions:

Statement of Task
Drafts of the report
Additional data gathering needs

The following materials (written documents) were made available to the committee in the closed sessions:

Materials submitted to committee by ReedSmith

Date of posting of Closed Session Summary:

November 20, 2019

Contact

Contact us

Location

Keck Center

500 5th St NW

Washington DC 20001, USA

Disclaimer

It is essential to the National Academies mission of providing evidence-based advice that participants in any of our meetings or events avoid political or partisan statements or commentary and maintain a culture of mutual respect. The statements and presentations during our meetings or events are solely those of the individual participants and do not necessarily represent the views of other participants or the National Academy of Sciences, which is a non-partisan, tax exempt organization that includes under its Charter the National Academy of Engineering and National Academy of Medicine, and that operates the National Research Council.

Meeting Closed

Fifth Committee Meeting: Clinical Utility of Treating Patients with Compounded “Bioidentical Hormone Replacement Therapy”

September 25, 2019

12:00 AM - 12:00 AM (ET)

Past

About

The National Academies of Sciences, Engineering, and Medicine is holding a closed session virtual meeting for the Committee on Clinical Utility of Treating Patients with Compounded "Bioidentical Hormone Replacement Therapy”.

Additional Information

Is it a Closed Session event?

Institution Closed

The following committee members were present at the closed sessions of the event

Ruth Parker (virtual)
Robert MacArthur (virtual)
Susan S. Ellenberg (virtual)
Jose Manautou (virtual)
Lesley H. Curtis (virtual)
Nancy Reame (virtual)
Rulla Tamimi (virtual)
Jennifer Fishman (virtual)
Donald Mattison (virtual)

The following topics were discussed in the closed sessions:

Statement of Task
Drafts of the report
Additional data gathering needs

Date of posting of Closed Session Summary:

November 20, 2019

Contact

Contact us

Disclaimer

It is essential to the National Academies mission of providing evidence-based advice that participants in any of our meetings or events avoid political or partisan statements or commentary and maintain a culture of mutual respect. The statements and presentations during our meetings or events are solely those of the individual participants and do not necessarily represent the views of other participants or the National Academy of Sciences, which is a non-partisan, tax exempt organization that includes under its Charter the National Academy of Engineering and National Academy of Medicine, and that operates the National Research Council.

Meeting Closed

Fourth Committee Meeting: Clinical Utility of Treating Patients with Compounded “Bioidentical Hormone Replacement Therapy”

August 6 - 7, 2019

Past

About

The National Academies of Sciences, Engineering, and Medicine is holding a closed session meeting for the Committee on Clinical Utility of Treating Patients with Compounded "Bioidentical Hormone Replacement Therapy”.

Additional Information

Is it a Closed Session event?

Institution Closed

The following committee members were present at the closed sessions of the event

Lesley H. Curtis
Susan S. Ellenberg
Nancy Reame (virtual)
Rulla Tamimi
Robert Macarthur (virtual)
Jose Manautou
Jennifer Fishman
Ruth Parker
Donald Mattison (virtual)
David Rubinow (virtual)
Adel Karara

The following topics were discussed in the closed sessions:

Statement of Task
Initial drafts of the report
Additional data gathering needs

The following materials (written documents) were made available to the committee in the closed sessions:

Summary of resources provided by Office of Tennessee Attorney General

Date of posting of Closed Session Summary:

August 09, 2019

Contact

Contact us

Location

Keck Center

500 5th St NW

Washington DC 20001, USA

Disclaimer

It is essential to the National Academies mission of providing evidence-based advice that participants in any of our meetings or events avoid political or partisan statements or commentary and maintain a culture of mutual respect. The statements and presentations during our meetings or events are solely those of the individual participants and do not necessarily represent the views of other participants or the National Academy of Sciences, which is a non-partisan, tax exempt organization that includes under its Charter the National Academy of Engineering and National Academy of Medicine, and that operates the National Research Council.

Meeting

Third Committee Meeting: Clinical Utility of Treating Patients with Compounded “Bioidentical Hormone Replacement Therapy”

June 27 - 28, 2019

Past

Materials

About

The National Academies of Sciences, Engineering, and Medicine is holding a closed session meeting for the Committee on Clinical Utility of Treating Patients with Compounded "Bioidentical Hormone Replacement Therapy”.

A brief virtual open session will be held from 12:45pm - 3:00pm.

Additional Information

Is it a Closed Session event?

Partially Closed

The following committee members were present at the closed sessions of the event

Lesley H. Curtis
Susan S. Ellenberg
Nancy Reame
Rulla Tamimi
Robert Macarthur
Jose Manautou
Jennifer Fishman (virtual)
Ruth Parker
Donald Mattison
David Rubinow (virtual)
Adel Karara

The following topics were discussed in the closed sessions:

Statement of Task
Additional data-gathering needs
Report drafts
Future meeting topics

The following materials (written documents) were made available to the committee in the closed sessions:

Dr. Rebecca Glaser (invited open session speaker) provided resources related to the clinical utility of compounded testosterone pellets.

Other powerpoint presentations from invited speakers.

Date of posting of Closed Session Summary:

July 02, 2019

Contact

Contact us

Disclaimer

It is essential to the National Academies mission of providing evidence-based advice that participants in any of our meetings or events avoid political or partisan statements or commentary and maintain a culture of mutual respect. The statements and presentations during our meetings or events are solely those of the individual participants and do not necessarily represent the views of other participants or the National Academy of Sciences, which is a non-partisan, tax exempt organization that includes under its Charter the National Academy of Engineering and National Academy of Medicine, and that operates the National Research Council.

Meeting

Second Committee Meeting: Clinical Utility of Treating Patients with Compounded “Bioidentical Hormone Replacement Therapy”

May 6 - 7, 2019

Past

Materials

About

The National Academies of Sciences, Engineering, and Medicine is pleased to announce the second open session meeting for the Committee on Clinical Utility of Treating Patients with Compounded "Bioidentical Hormone Replacement Therapy”. The public workshop will be held on May 6th, 2019 in the Keck Center Building in Room 100 (500 5th Street NW, Washington DC, 20001) from 8:45am to 5:00pm (ET).

This workshop will provide an opportunity for the committee to gather data and context information from relevant subject matter experts. There will also be a short Q&A session with the viewing public.

A recording of the meeting can now be viewed here.

Additional Information

Is it a Closed Session event?

Partially Closed

The following committee members were present at the closed sessions of the event

Lesley H. Curtis
Susan S. Ellenberg
Aaron Kesselheim
Nancy Reame
Rulla Tamimi
Robert Macarthur
Jose Manautou
Jennifer Fishman
Ruth Parker
Donald Mattison
David Rubinow (virtual)
Adel Karara

The following topics were discussed in the closed sessions:

Statement of Task
Outcomes of the public workshop
Additional data-gathering needs
Future meeting topics

The following materials (written documents) were made available to the committee in the closed sessions:

Dr. Daved Rosensweet (invited open session speaker) provided resources and stakeholder statements related to the clinical utility and use of compounded bioidentical hormone replacement therapy products.

Other powerpoints presentations from invited speakers.

Update (8.22.2019): the National Academies held a conference call with Dr. Rosenweet to review additional pieces of evidence related to cBHT costs, bioavailibility testing, formulations, and use, Dr. Rosensweet submitted additional resources for the committee to review. See supporting files.

Date of posting of Closed Session Summary:

January 07, 2025

Contact

Contact us

Disclaimer

It is essential to the National Academies mission of providing evidence-based advice that participants in any of our meetings or events avoid political or partisan statements or commentary and maintain a culture of mutual respect. The statements and presentations during our meetings or events are solely those of the individual participants and do not necessarily represent the views of other participants or the National Academy of Sciences, which is a non-partisan, tax exempt organization that includes under its Charter the National Academy of Engineering and National Academy of Medicine, and that operates the National Research Council.

Meeting

First Committee Meeting: Clinical Utility of Treating Patients with Compounded “Bioidentical Hormone Replacement Therapy”

March 5 - 6, 2019

Past

Materials

About

The National Academies of Sciences, Engineering, and Medicine is pleased to announce the first open session meeting for the Committee on Clinical Utility of Treating Patients with Compounded "Bioidentical Hormone Replacement Therapy”. The public meeting will be held on March 5th, 2019 in the Keck Center Building in Room 101 (500 5th Street NW, Washington DC, 20001) from 1:00pm to 5:15pm (ET).

This meeting will provide an opportunity for the committee to discuss their Statement of Task with representatives from the U.S. Food and Drug Administration (the study sponsors) and gather data and context information from relevant subject matter experts. There will also be a short Q&A session with the viewing public.

Additional Information

Is it a Closed Session event?

Partially Closed

The following committee members were present at the closed sessions of the event

Jerome F. Strauss
Lesley H. Curtis (virtual)
Susan S. Ellenberg
Aaron Kesselheim (virtual)
Nancy Reame
Rulla Tamimi
Robert Macarthur
Jose Manautou
Jennifer Fishman
Ruth Parker
Donald Mattison

The following topics were discussed in the closed sessions:

• The statement of task (SOT) and scope of the study with the study sponsors
• A discussion of potential bias or conflicts of interest
• Study approach
• Research methods
• Topics for upcoming meetings

The following materials (written documents) were made available to the committee in the closed sessions:

Resources from PCCA

Date of posting of Closed Session Summary:

March 13, 2019

Contact

Contact us

Location

Keck Center

500 5th St NW

Washington DC 20001, USA

Disclaimer

It is essential to the National Academies mission of providing evidence-based advice that participants in any of our meetings or events avoid political or partisan statements or commentary and maintain a culture of mutual respect. The statements and presentations during our meetings or events are solely those of the individual participants and do not necessarily represent the views of other participants or the National Academy of Sciences, which is a non-partisan, tax exempt organization that includes under its Charter the National Academy of Engineering and National Academy of Medicine, and that operates the National Research Council.

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Clinical Utility of Treating Patients with Compounded “Bioidentical Hormone Replacement Therapy”

Dropdown items

Report Release Webinar: The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of the Safety, Effectiveness, and Use