[Federal Register Volume 80, Number 176 (Friday, September 11, 2015)]
[Notices]
[Pages 54794-54795]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-22949]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-3156]
Drug Interactions With Hormonal Contraceptives: Public Health and
Drug Development Implications; Public Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting entitled ``Drug Interactions with Hormonal Contraceptives:
Public Health and Drug Development Implications'' and an opportunity
for public comment on the topic of drug interactions with hormonal
contraceptives (HCs). The goal of this public meeting is to provide an
opportunity for FDA to seek input from experts on the public health
concerns associated with use of HCs and interacting drugs that might
affect efficacy and safety, pharmacokinetic (PK)/pharmacodynamic (PD)
considerations in designing drug interaction studies with HCs during
drug development, and approaches to translating the results of drug
interaction information into informative labeling and communication.
The input received may be used to refine FDA's thinking on HC drug
interaction study design and interpretation, and labeling communication
on drug interaction risk.
DATES: The public meeting will be held on November 9, 2015, from 8:30
a.m. to 4:30 p.m. Individuals who wish to attend the meeting in person
or via Web cast must register by October 9, 2015. Please submit either
electronic or written comments by December 15, 2015, to receive
consideration. See the SUPPLEMENTARY INFORMATION section for
information on how to register for the meeting and submit electronic or
written comments.
ADDRESSES: The meeting will be held at the FDA White Oak Campus, 10903
New Hampshire Ave., Bldg. 31 Conference Center, Section A of the Great
Room (Rm. 1503), Silver Spring, MD 20993. Entrance for the public
[[Page 54795]]
meeting participants (non-FDA employees) is through Building 1, where
routine security check procedures will be performed. For more
information on parking and security procedures, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
Submit electronic comments to http://www.regulations.gov. Submit
written comments to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD
20852. All comments should be identified with the docket number found
in brackets in the heading of this document.
FDA will post the agenda approximately 5 days before the meeting
at: http://www.fda.gov/Drugs/NewsEvents/ucm459342.htm.
FOR FURTHER INFORMATION CONTACT: Christine Le, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3196, Silver Spring, MD 20993, 301-796-
2398, email: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
In general, HCs are highly effective in preventing pregnancy when
used correctly. However, concomitant use of other drugs may affect the
safety and/or efficacy of HCs due to drug interactions affecting either
blood levels (PK) and/or physiologic effects (PD) of HC components
(e.g., estrogen and progestins). Understanding drug interaction
potential of HCs and other drugs is important when investigating HC-
related issues, and in the design and conduct of clinical trials.
Evolving knowledge on drug interaction mechanisms has led to new
insights and increased interest in the clinical investigation of drug
interactions with HCs.
Historically, most drug interaction studies conducted during drug
development with HCs have not had a clearly stated rationale for the
choice of HCs being studied. Questions remain as to whether the study
results of specific contraceptive steroids can be extrapolated to other
progestins or estrogens or other dose strengths. The choice of HC is
important because different progestins may have different metabolic
and/or transporter pathways and safety profiles. Without a mechanistic
understanding of the underlying drug-drug interaction (DDI) mechanism,
it is difficult to interpret and extrapolate study results from one HC
to another.
II. Discussion Topics for the Meeting and for Public Comments
The public meeting on November 9, 2015, will include a discussion
of the following topics on which FDA is also seeking public comment:
Public health concerns associated with use of HCs and
interacting drugs that might affect efficacy and safety.
PK and PD considerations in designing drug interaction
studies with HCs during drug development. Key elements in designing a
study include a mechanistic understanding of potential DDI mechanisms,
the choice of contraceptive products and their dose, study population/
duration, and proper selection of a PK alone or PK-PD-based drug
interaction study approach.
Drug interaction study result interpretation and its
potential impact on guidance of HC use in women of childbearing
potential who are enrolled in clinical trials for other therapeutic
agents during drug development.
The current approach of translating the results from drug
interaction studies into labeling recommendations and opportunities to
improve the communication to healthcare providers.
Research opportunities and tools for investigating the
safe use of HCs in the presence of other drugs.
The input received may be used to refine FDA's thinking on the drug
interaction study design with HCs and labeling communication of drug
interaction risks with HCs.
III. Meeting Attendance and Participation
If you wish to attend these meetings, register online at https://www.surveymonkey.com/r/HC-DDIMeeting. Please register by October 9,
2015. Those who are unable to attend the meetings in person can
register to view a live Web cast of the meetings. You will be asked to
indicate in your registration whether you plan to attend in person or
via the Web cast. Your registration should also contain your complete
contact information, including name, title, affiliation, address, email
address, and phone number.
Seating will be limited, so early registration is recommended.
Registration is free and will be on a first-come, first-served basis.
However, FDA may limit the number of participants from each
organization based on space limitations. Registrants will receive
confirmation once they have been accepted. Onsite registration on the
day of the meetings will be based on space availability. If you need
special accommodations because of disability, please contact Christine
Le (see FOR FURTHER INFORMATION CONTACT) at least 7 days before the
meeting.
FDA will hold an open public comment period during the November 9,
2015, public meeting to give the public an opportunity to comment.
Registration for open public comment will occur at the registration
desk on the day of the meeting on a first-come, first-served basis.
IV. Comments
Regardless of whether you attend this meeting, you can submit
electronic or written comments, including responses to the public
docket (see ADDRESS above), by December 15, 2015. Received comments may
be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.
V. Transcripts
Transcripts for the November 9, 2015, meeting will be posted, when
available, at http://www.fda.gov/Drugs/NewsEvents/ucm459342.htm.
Dated: September 4, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-22949 Filed 9-10-15; 8:45 am]
BILLING CODE 4164-01-P