Notice2023-05962
Changes to Third-Party Vendors for Risk Evaluation and Mitigation Strategies; Establishment of a Public Docket; Request for Comments
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
March 23, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is announcing the establishment of a docket to solicit comments on factors that generally should be considered by the Secretary of Health and Human Services (Secretary) when reviewing modification requests from sponsors of drugs subject to risk evaluation and mitigation strategies (REMS) related to changes in third-party vendors engaged by sponsors to aid in implementation and management of the strategies.
Full Text
<html>
<head>
<title>Federal Register, Volume 88 Issue 56 (Thursday, March 23, 2023)</title>
</head>
<body><pre>
[Federal Register Volume 88, Number 56 (Thursday, March 23, 2023)]
[Notices]
[Pages 17578-17579]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-05962]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-0573]
Changes to Third-Party Vendors for Risk Evaluation and Mitigation
Strategies; Establishment of a Public Docket; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; establishment of a public docket; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing the establishment of a docket to solicit comments on factors
that generally should be considered by the Secretary of Health and
Human Services (Secretary) when reviewing modification requests from
sponsors of drugs subject to risk evaluation and mitigation strategies
(REMS) related to changes in third-party vendors engaged by sponsors to
aid in implementation and management of the strategies.
DATES: Submit either electronic or written comments by July 21, 2023.
See the SUPPLEMENTARY INFORMATION section for registration date and
information.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. 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 at the end of July 21, 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-0573 for ``Proposed Changes to Third-Party Vendors
Establishment of a Public Docket; Request for Comments.'' 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 and 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: Marcus Cato, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 4475, 301-796-2380,
<a href="/cdn-cgi/l/email-protection#aae5f9ef84fae7e1fef8efedf9eacccecb84c2c2d984cdc5dc"><span class="__cf_email__" data-cfemail="98d7cbddb6c8d5d3cccadddfcbd8fefcf9b6f0f0ebb6fff7ee">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Section 505-1 of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 355-1), authorizes FDA to require a REMS if FDA
determines that a REMS is necessary to ensure that the benefits of the
drug outweigh its risks. A REMS is a required risk management strategy
that employs tools beyond prescribing information to ensure that the
benefits of a drug outweigh its risks. A REMS may require a Medication
Guide (or patient package insert) to provide risk information to
patients, a communication plan to disseminate risk information to
healthcare providers, and certain packaging and safe disposal systems
for drugs that pose a serious risk of abuse or overdose. FDA may also
require certain elements to assure safe use (ETASU) when such elements
are necessary to mitigate a specific serious risk listed in the
labeling of the drug. ETASU may include, for example, requirements that
healthcare providers who prescribe the drug have particular training or
experience, that patients using the drug be monitored, or that the drug
be dispensed to patients with evidence or other documentation of safe-
use conditions. Certain REMS with ETASU may also include an
implementation system through which the applicant is able to monitor
and evaluate implementation of the ETASU
[[Page 17579]]
and work to improve their implementation. Finally, REMS generally must
have a timetable for submission of assessments of the strategy.
FDA can require a REMS before initial approval of a new drug
application (NDA) or biologics license application (BLA) or after the
drug has been approved if FDA becomes aware of new safety information
about a drug and determines that a REMS is necessary to ensure that the
benefits of the drug outweigh its risks. Under section 505-1(i)(1) of
the FD&C Act, a drug that is approved under an abbreviated new drug
application (ANDA) is only required to have certain elements of a REMS
if these elements are required for the applicable listed drug: a
Medication Guide or patient package insert, a packaging or disposal
requirement, ETASU, and an implementation system.
When applicants develop REMS with ETASU, particularly those ETASU
that require verification of certain conditions before the drug is
dispensed, they often hire third-party vendors to design operational
components to help implement and manage the program requirements. These
third-party vendors, often referred to as REMS administrators, may
perform a variety of functions for the REMS program, including building
and operating a centralized database or repository for patient
enrollment, prescriber and pharmacy certifications, and wholesaler
enrollments. They often host a website or web portal that participants,
such as patients, prescribers, pharmacies, and wholesalers, use to
enroll in the program, and they provide the technological means for
pharmacies and other dispensers to perform the necessary verifications
at the point of dispensing. These operational components are often
referred to collectively as the ``REMS system.'' In many cases,
therefore, the REMS administrator performs critical functions in the
daily operations of a REMS which directly impact patient access to the
drug.
Applicants may submit modifications to their REMS at any time after
approval which propose the addition, modification, or removal of any
goal or element of the approved strategy. While FDA does not approve
REMS administrators or changes in REMS administrators per se, an
applicant's decision to change a REMS administrator may affect the REMS
system, prompting an applicant to propose a REMS modification.
Implementing such a change has the potential to cause significant
disruptions in the operations of the program, including the ability for
stakeholders to interact with the tools necessary to fulfill the
various REMS requirements. These disruptions can impact patients'
ability to access the drug.
The Consolidated Appropriations Act, 2023, signed into law on
December 29, 2022, specified that ``[n]ot later than 90 days after the
date of enactment of this Act, the Secretary shall open a single public
docket to solicit comments on factors that generally should be
considered by the Secretary when reviewing requests from sponsors of
drugs subject to [REMS] to change third-party vendors engaged by
sponsors to aid in implementation and management of the strategies. . .
. Such factors include the potential effects of changes in third-party
vendors on--(A) patient access; and (B) prescribing and administration
of the drugs by healthcare providers.''
II. Request for Comments
FDA is soliciting comments from stakeholders regarding the factors
that FDA should consider when it reviews a proposed REMS modification
that is prompted by or related to a change in a REMS administrator for
a REMS with ETASU. In addition to general factors, such as effect of
the modification on patient access and prescribing and administration
by healthcare providers, FDA is interested in comments on the following
topics:
1. Comment on any stakeholder input that the applicant and/or REMS
administrator should obtain prior to developing and implementing a new
REMS system, including the extent and timing of stakeholder input.
2. Comment on whether the sponsor and/or REMS administrator should
conduct testing of the changes to the operation of the REMS system
prior to full implementation including:
<bullet> User acceptance testing with stakeholders and evaluation
of any unexpected impact on stakeholder workflow
<bullet> An assessment of REMS data flows, including whether REMS
data from the existing REMS system can be timely and successfully
transferred to a new REMS system.
3. Comment on the amount of time needed to transition stakeholders
from one REMS system to another REMS system (e.g., enrollment or
recertification), and the factors that go into that time frame.
4. Comment on whether the sponsor and/or the REMS administrator
should conduct a failure modes and effects analysis to identify and
plan for system failures. This includes providing for adequate support
services in the event that the system fails to work as intended
following full implementation of the new REMS system.
5. Comment on the metrics that the sponsor should capture to
evaluate whether the REMS system was successfully and efficiently
implemented.
Dated: March 20, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-05962 Filed 3-22-23; 8:45 am]
BILLING CODE 4164-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on March 23, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.