Evaluation of the Safety of Drugs and Biological Products used during Lactation

Lactation Workshop Announcement

FDA’s Division of Pediatric and Maternal Health in CDER, is announcing a 2-day public workshop, “Evaluation of the Safety of Drugs and Biological Products used during Lactation”. The purpose of this 2-day workshop is to provide a forum to discuss the current state and future directions of the collection of data on the potential risks to breastfed infants with maternal use of medications during lactation. The workshop will review current approaches to the collection of data when drugs are used or expected to be used during lactation. The workshop will also discuss and consider novel approaches to improve the quality and quantity of data to inform about potential risks of medication use during lactation and to raise awareness and engage stakeholders about communication of safety information related to maternal use of medications during lactation.   Day 1 of the workshop will focus on review and discussion of current approaches for the collection of data, a review and discussion of gaps in our present knowledge and a discussion of strategies to communicate safety information related to maternal use of medications during lactation.  Day 2 of the workshop will be a discussion of the Day 1 information with a focus on consideration of novel approaches to improve the quality and quantity of data available to assess the safety of medications used during lactation.

The public workshop will be held on:

DATE: April 27 and 28, 2016

TIME: 8:00 a.m. to 5:00 p.m. (Day 1)

          8:00 a.m. to 1:00 p.m. (Day 2)

LOCATION:  The public workshop will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31, the Great Room (Rm. 1503A), Silver Spring, MD 20993-0002. Entrance for the public workshop participants (non-FDA employees) is through Bldg. 1 where routine security check procedures will be performed. For parking and security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm

REGISTRATION:  Participation can be either in person attendance or by webcast. There is no fee to attend the public workshop, but attendees should register in advance. Space is limited, and registration for in person attendance will be on a first-come, first-served basis. Persons interested in attending this workshop must register by sending an email to Lactation@fda.hhs.gov by April 8, 2016. Please include: 1) first and last name, 2) contact phone or email, 3) live attendance or via webcast 4) indicate if you plan to attend Day 1, Day 2 or both days. For those without Internet access, please contact Denise Pica-Branco at denise.picabranco@fda.hhs.gov or Denise.johnson-lyles@fda.hhs.gov to register. Onsite registration will not be available.

MORE INFORMATION: Contact Denise Pica-Branco, (301)796-1732; FAX (301)796-9858, e-mail denise.picabranco@fda.hhs.gov or Denise Johnson-Lyles, (301)796-6169; FAX (301)796-9858, e-mail denise.johnson-lyles@fda.hhs.gov

 

WEBCAST:   https://collaboration.fda.gov/lactation0416/

FINAL AGENDA PDF - 79KB)

Lactation Workshop Panel Discussion Questions (PDF - 46KB)

PRESENTATION SLIDES DAY 1

• Panelists and Presenters (PDF - 77KB)
• Baker: The Benefits of Breastfeeding (PDF - 894KB
• Chambers: Mother To Baby Services for Counseling on Exposures in Breastfeeding: When More TLC is Needed (PDF - 1,042KB)
• Johnson:  FDA Perspecitves on Drug Use in Lactation (PDF - 598KB)
• Lawrence:  Drugs in Breastmilk: Benefits versus Risks (PDF - 3944KB)
• Plumer: LactMed Outreach Activities for the Professional and Consumer (PDF - 2,275KB)
• Reece-Stremtan: Physician to Physician Education in the 21st Century (PDF - 1710KB)
• Ren:  Research on Drugs in Pregnancy and Lactation at NIH (PDF - 536KB)
• Sauberan: FDA Pregnancy and Lactation Labeling Rule: Considerations for Populating Lactation Section 8.2 (PDF - 1,113KB)
• Short: Roadblocks to Clinically Relevant Information Regarding Drug Use and Lactation (PDF - 471KB)
• Teil: “What do we currently know?” An Example from Industry (PDF - 83KB)
• T.White: Nonclinical Studies – What animal studies can (and can’t) tell us about drugs in milk (PDF - 208KB)
• Walker: FDA Public Workshop: Evaluation of the safety of drugs and biological products used during lactation (PDF - 777KB)
• Yao: Evaluation of the Safety of Drugs and Biological Products used during Lactation (PDF - 785KB)

PRESENTATION SLIDES DAY 2

• Anderson: Modeling Drug Passage into Breastmilk  (PDF - 863KB)
• Baker: Best Practices for Conducting Clinical Lactation Studies (PDF - 894KB)
• Chambers:  Human Milk Biorepository  (PDF - 412KB)
• Hebert: Lactation Study Basics Lessons Learned (PDF - 4,300KB)
• Nelson: Ethical Considerations in the Design and Conduct of Clinical Lactation Studies (PDF - 893KB)
• Simpson: An Industry Perspective on Conducting a Lactation Study (PDF - 463KB)

 

April 27:

 

Part 1:https://collaboration.fda.gov/p9c1hqaf7qv/

Part 2: https://collaboration.fda.gov/p3pmzy99d4h/

Part 3: https://collaboration.fda.gov/p2g9lkdrjbj/

Part 4: https://collaboration.fda.gov/p1cx4vbqk1f/

 

April 28:

Part 1: https://collaboration.fda.gov/p26cajkffle/

Part 2: https://collaboration.fda.gov/p1g3zev3f6t/

 

 

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