Notice2023-17718
Optimizing the Use of Postapproval Pregnancy Safety Studies; Public Workshop; Request for Comments
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Published
August 17, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is announcing a public workshop entitled "Optimizing the Use of Postapproval Pregnancy Safety Studies" convened by the Duke-Margolis Center for Health Policy and supported by a cooperative agreement between FDA and Duke-Margolis. This workshop will include discussions of designs of postapproval pregnancy safety studies for drug and biological products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) and experiences with implementing these studies. The workshop also will include discussion of considerations for further development of a framework that describes how data from different types of postapproval pregnancy safety studies might optimally be used when it has been determined that this data should be collected.
Full Text
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<title>Federal Register, Volume 88 Issue 158 (Thursday, August 17, 2023)</title>
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[Federal Register Volume 88, Number 158 (Thursday, August 17, 2023)]
[Notices]
[Pages 56024-56025]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-17718]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-3104]
Optimizing the Use of Postapproval Pregnancy Safety Studies;
Public Workshop; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop; request for comments.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
workshop entitled ``Optimizing the Use of Postapproval Pregnancy Safety
Studies'' convened by the Duke-Margolis Center for Health Policy and
supported by a cooperative agreement between FDA and Duke-Margolis.
This workshop will include discussions of designs of postapproval
pregnancy safety studies for drug and biological products regulated by
the Center for Drug Evaluation and Research (CDER) and the Center for
Biologics Evaluation and Research (CBER) and experiences with
implementing these studies. The workshop also will include discussion
of considerations for further development of a framework that describes
how data from different types of postapproval pregnancy safety studies
might optimally be used when it has been determined that this data
should be collected.
DATES: The public workshop will be held in person and virtually on
September 18, 2023, from 10 a.m. to 4 p.m., Eastern Daylight Time, and
on September 19, 2023, from 10 a.m. to 2:30 p.m. Either electronic or
written comments on this public workshop must be submitted by November
30, 2023. See the SUPPLEMENTARY INFORMATION section for registration
date and information.
ADDRESSES: The public workshop will be held in person at the National
Press Club, 529 14th St. NW, Washington, DC 20045 and virtually using
the Zoom Platform. The link for the public workshop will be sent to
registrants upon registration for virtual attendance.
You may submit comments as follows. Please note that late, untimely
filed comments will not be considered for the subsequent workshop
report describing the proposed framework, which will be published by
October 2, 2024. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing
system will accept comments until 11:59 p.m. Eastern Time on November
30, 2023. Comments received by mail/hand delivery/courier (for written/
paper submissions) will be considered timely if they are received on or
before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2023-N-3104 for ``Optimizing the Use of Postapproval Pregnancy
Safety Studies.'' Received comments, those filed in a timely manner
(see ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions: To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments. You must identify this information as ``confidential.''
Any information marked as ``confidential'' will not be disclosed except
in accordance with 21 CFR 10.20 and other applicable disclosure law.
For more information about FDA's posting of comments to public dockets,
see 80 FR 56469, September 18, 2015, or access the information at:
<a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Commander Vicky Chan, Food and Drug
Administration, CDER, 10903 New Hampshire Ave., Bldg. 22, Rm. 3404,
Silver Spring, MD 20993, 301-796-1639, <a href="/cdn-cgi/l/email-protection#a2f4cbc1c9db8ce1cac3cce2c4c6c38ccacad18cc5cdd4"><span class="__cf_email__" data-cfemail="22744b41495b0c614a434c624446430c4a4a510c454d54">[email protected]</span></a> or Anne
Taylor, CBER, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-402-7911,
<a href="/cdn-cgi/l/email-protection#edac838388c3b98c9481829fad8b898cc385859ec38a829b"><span class="__cf_email__" data-cfemail="793817171c572d180015160b391f1d185711110a571e160f">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
[[Page 56025]]
I. Background
In the United States, approximately 5.5 million pregnancies occur
each year (Ref. 1). Half of individuals who are pregnant use at least
one drug or biological product to treat chronic (e.g., diabetes,
seizure disorders, or asthma), acute (e.g., infection) or serious
medical conditions (Ref. 2). Typically at the time of initial market
approval, there are limited to no human data on the safety of drug or
biological products used during pregnancy. As a result, for most
products, human pregnancy safety data are collected after a product is
available on the market (i.e., postapproval).
In May 2019, FDA published a draft Guidance for Industry entitled
``Postapproval Pregnancy Safety Studies'' (available at <a href="https://www.fda.gov/media/124746/download">https://www.fda.gov/media/124746/download</a>), which discusses the strengths and
limitations of postapproval study types including studies based on
registry data and cohort studies using electronic health records or
claims data. However, more research is needed to better understand the
key considerations for determining the optimal postapproval study
designs to obtain timely evidence to ensure the safe use of drug and
biological products in pregnant individuals. The public workshop is a
preliminary discussion with stakeholders to inform FDA's further
development of a framework and also meets a performance goal under the
FDA User Fee Reauthorization Act of 2022, in accordance with the
Prescription Drug User Fee Act (PDUFA) Reauthorization Performance
Goals and Procedures Fiscal Years 2023 Through 2027 letter (PDUFA VII
Commitment Letter), which is available at <a href="https://www.fda.gov/media/151712/download">https://www.fda.gov/media/151712/download</a>. Specifically, the PDUFA VII Commitment Letter outlines
the commitment of a public workshop to discuss postapproval pregnancy
safety studies to facilitate determination of ideal study designs.
II. Topics for Discussion at the Public Workshop
The public workshop will include the following topics for
discussion:
1. FDA's considerations for constructing a framework describing how
data from different types of post-market pregnancy safety studies might
optimally be used.
2. Stakeholders' perspectives on opportunities to optimize
postapproval pregnancy safety study types and designs.
3. Design considerations and potential approaches to bridge
knowledge gaps in developing the framework, including understanding how
the Sentinel Initiative (i.e., Sentinel System and Biologics
Effectiveness and Safety (BEST)) may address these gaps.
4. Stakeholders' perspectives on considerations for FDA's proposed
framework.
Meeting updates, the agenda, and background materials (if any) will
be made available at <a href="https://duke.is/nj5kg">https://duke.is/nj5kg</a> prior to the workshop.
III. Participating in the Public Workshop
Registration: To register for this hybrid public workshop, please
visit the following website: <a href="https://duke.is/nj5kg">https://duke.is/nj5kg</a>. Please provide
complete contact information for each attendee, including attendance
format (in-person or virtual), name, title, affiliation, and email.
Registration is free and based on space availability, with priority
given to early registrants. Persons interested in attending this public
workshop must register by 10 a.m. Eastern Daylight Time, September 18,
2023. Early registration is recommended due to limited seating;
therefore, FDA may limit the number of participants from each
organization. Registrants will receive a confirmation email when they
have been registered.
If you need special accommodations due to a disability, please
contact Luke Durocher, Duke-Margolis Center for Health Policy, 202-621-
2800, <a href="/cdn-cgi/l/email-protection#f895998a9f9794918b9d8e9d968c8bb89c8d939dd69d9c8d"><span class="__cf_email__" data-cfemail="aac7cbd8cdc5c6c3d9cfdccfc4ded9eacedfc1cf84cfcedf">[email protected]</span></a>, no later than 5 p.m. Eastern Time,
September 5, 2023.
Requests for Oral Comments: During online registration, you may
indicate if you wish to speak during a public comment session. We will
do our best to accommodate requests to make public comments.
Individuals and organizations with common interests are urged to
consolidate or coordinate their comments and request a time for joint
commentary. All requests to make oral comments must be received by
11:59 p.m. Eastern Time on September 5, 2023. FDA will determine the
amount of time allotted to each commenter and the approximate time each
comment is to begin and will select and notify participants by
September 11, 2023.
Transcripts: Please be advised that as soon as a transcript of the
public workshop is available, it will be accessible at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. It may be viewed by the Dockets Management Staff.
IV. References
The following references marked with an asterisk (*) have been
placed on display at the Dockets Management Staff (see ADDRESSES) and
are available for viewing by interested persons between 9 a.m. and 4
p.m., Monday through Friday; they are also available electronically at
<a href="https://www.regulations.gov">https://www.regulations.gov</a>. References without asterisks are not on
public display at <a href="https://www.regulations.gov">https://www.regulations.gov</a> because they have
copyright restriction. Some may be available at the website address, if
listed. References without asterisks are available for viewing only at
the Dockets Management Staff. FDA has verified the website addresses,
as of the date this document publishes in the Federal Register, but
websites are subject to change over time.
*1. Centers for Disease Control and Prevention, National Center for
Health Statistics. ``U.S. Pregnancy Rates Drop During Last Decade.''
Hyattsville (MD); 2023 April 12, Available from: <a href="https://www.cdc.gov/nchs/pressroom/nchs_press_releases/2023/20230412.htm">https://www.cdc.gov/nchs/pressroom/nchs_press_releases/2023/20230412.htm</a>.
2. Mitchell, A.A, S.M. Gilboa, M.M. Werler, et al. ``Medication Use
During Pregnancy, with Particular Focus on Prescription Drugs: 1976-
2008.'' American Journal of Obstetrics & Gynecology 2011;205:51.e1-
8.
Dated: August 14, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-17718 Filed 8-16-23; 8:45 am]
BILLING CODE 4164-01-P
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