80 FR 54794 - Drug Interactions With Hormonal Contraceptives: Public Health and Drug Development Implications; Public Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 176 (September 11, 2015)

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.

[Federal Register Volume 80, Number 176 (Friday, September 11, 2015)]
[Notices]
[Pages 54794-54795]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-22949]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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