[Federal Register Volume 84, Number 246 (Monday, December 23, 2019)]
[Notices]
[Pages 70557-70559]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27475]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-D-5743]
Importation of Certain Food and Drug Administration-Approved
Human Prescription Drugs, Including Biological Products, Under Section
801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act; Draft
Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing the availability of a draft guidance for industry entitled
``Importation of Certain FDA-Approved Human Prescription Drugs,
Including Biological Products, under Section 801(d)(1)(B) of the
Federal Food, Drug, and Cosmetic Act.'' This draft guidance describes
procedures to obtain a National Drug Code (NDC) for an FDA-approved
prescription drug that is imported into the United States in compliance
with the Federal Food, Drug, and Cosmetic Act (FD&C Act), which would
provide an additional avenue through which drugs could be sold at a
lower cost in the U.S. market. This draft guidance is intended to
address certain challenges in the private market faced by manufacturers
seeking to sell their drugs at lower costs.
DATES: Submit either electronic or written comments on the draft
guidance by February 21, 2020 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
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 https://www.regulations.gov.
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:
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.
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-2019-D-5743 for ``Importation of Certain FDA-Approved Human
Prescription Drugs, Including Biological Products, under Section
801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
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 https://www.regulations.gov.
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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov 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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
[[Page 70558]]
Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002 or the
Office of Communication, Outreach, and Development, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002.
Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Lyndsay Hennessey, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-7605, or Stephen
Ripley, Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver
Spring, MD 20993-0002, 240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Importation of Certain FDA-Approved Human Prescription
Drugs, Including Biological Products, under Section 801(d)(1)(B) of the
Federal Food, Drug, and Cosmetic Act,'' which, when finalized, will
represent the Agency's current thinking on the importation of multi-
market approved (MMA) products. This draft guidance describes
procedures to obtain an NDC for an FDA-approved prescription drug that
is imported into the United States in compliance with section 801 of
the FD&C Act (21 U.S.C. 381), which would provide an additional avenue
through which drugs could be sold at a lower cost in the U.S. market.
In recent years, FDA has become aware that some drug manufacturers may
be interested in offering certain of their drugs at lower costs and
that obtaining additional NDCs for these drugs may help them to address
certain challenges in the private market. This guidance is not intended
to address the applicability of the Medicaid drug rebate program for
manufacturers. This guidance is intended to outline a potential pathway
by which manufacturers could obtain an additional NDC for an FDA-
approved drug that was originally intended to be marketed in a foreign
country. This guidance specifically addresses the importation of FDA-
approved drugs that were also authorized for sale in a foreign country
in which the drugs were originally intended to be marketed (``MMA
product''). This guidance describes: (1) The process for submitting a
supplement to an approved FDA application for an MMA product; (2) the
recommended labeling for an MMA product; (3) the process for
registration and listing and for obtaining an NDC for the MMA product;
(4) the requirements of section 582 of the FD&C Act (21 U.S.C. 360eee-
1) as added by the Drug Supply Chain Security Act (DSCSA) (Title II of
Pub. L. 113-54); (5) recommendations related to procedures for
importation of the MMA product; and (6) other FDA requirements
applicable to MMA products.
This guidance, when finalized, will help ensure manufacturers are
aware of procedures to provide access to lower-cost drugs in the United
States.\1\ The guidance details procedures that will enable
manufacturers to obtain an additional NDC for the MMA product, which
could allow greater pricing flexibility for a drug or biological
product. The additional NDC also will support pharmacovigilance,
accurate billing and reimbursement, and facilitate clearance of the MMA
products through customs. This draft guidance is not final nor is it in
effect at this time.
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\1\ Elsewhere in this issue of the Federal Register, FDA is
issuing a Notice of Proposed Rulemaking under 21 U.S.C. 384 to offer
a pathway for importation of drugs from Canada without the
authorization of the manufacturer.
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This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on the
importation of MMA products. It does not establish any rights for any
person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.
II. Issues for Consideration
As previously noted, FDA is interested in receiving comments on the
draft guidance. Regarding the approach set forth in the draft guidance,
in addition to any other issues addressed, FDA requests that commenters
consider the following issues when submitting comments:
1. Are there additional considerations for certain types of drug
products with special handling, such as sterile injectables, drugs with
boxed warnings, drugs with REMS (Risk Evaluation and Mitigation
Strategy), controlled substances, or drugs that do not meet the
definition of ``product'' under the DSCSA (21 U.S.C. 360eee(13))? Are
there additional considerations for combination products related to the
content of the guidance (e.g., supplement, labeling, NDC) that would
warrant additional guidance for use of this approach for those
products? To the extent that interested parties believe that different
or additional considerations from those described in the draft guidance
should apply to such an approach for combination products, we are
interested in input on that, as well.
2. The draft guidance uses ``MMA product'' to describe FDA-approved
drugs that were originally intended to be marketed in a foreign country
and also authorized for sale in that foreign country. Is this new term
adequate and understandable? Is there another term that would provide
more clarity regarding the products discussed in the guidance?
3. The draft guidance describes how an NDC could be obtained for
MMA products. What is the effect of a manufacturer using a new labeler
code as opposed to a new product code to distinguish these products,
such as for reimbursement?
4. The draft guidance recommends a labeling statement in the FDA-
approved labeling for the MMA product, including the carton and
container label, to assist pharmacists and others in accurately
identifying, dispensing, and billing for these products. FDA seeks
comment on the specific wording that could be included in the statement
to differentiate MMA products from other drugs that are not the subject
of the guidance, if finalized, and to help ensure MMA products are
easily identifiable to pharmacists and not confusing to patients. FDA
also seeks comment on other types of distinguishing characteristics on
the carton and container label that would further enable pharmacists to
identify an MMA product and distinguish it from other packages of the
FDA-approved drug, without confusing patients and consistent with other
applicable requirements relating to carton and container labeling.
Additionally, would other possible mechanisms, such as a Dear
Healthcare Provider letter, provide further clarity and reduce
confusion for pharmacists and other healthcare providers as well as
patients?
5. We request comment about how much, on average, the labeling and
packaging changes described in the draft guidance would cost drug
manufacturers and repackagers or relabelers. Are there other ways to
[[Page 70559]]
distinguish the appearance of an MMA product? We also request comment
about alternative labeling approaches that would display the required
information with equal prominence but may result in lower costs.
6. The draft guidance describes procedures for manufacturers of
drug products approved under new drug applications or biologics license
applications to obtain an additional NDC for an MMA product. FDA is
interested as to whether manufacturers of generic drugs approved under
an abbreviated new drug application confront similar pricing issues
such that it would be appropriate to provide guidance on a similar
approach for generic drugs. To the extent that interested parties
believe that different considerations should apply to such an approach
for generic drugs from those described in the draft guidance, input is
requested on that as well.
7. There are complex considerations that impact biosimilar
development, market entry, and uptake. We are interested in the
possible impacts of MMA products that are biological products on
biosimilar development, market entry, and uptake.
8. Similarly, there are complex considerations impacting generic
drug market entry. We are interested in the possible impacts of MMA
products on generic drug development and market entry.
9. Are there voluntary steps a manufacturer may take in addition to
the requirements in the DSCSA to ensure the security of the supply
chain for products imported pursuant to the guidance?
10. Are there any potential risks associated with the importation
of products as described in the draft guidance that could be addressed
by a rulemaking? For example, to what extent, if any, are there
additional procedures that might better protect against entities
seeking to introduce counterfeit drugs in the United States? If so,
please be specific about the potential risk and how it could be
addressed through rulemaking.
III. Paperwork Reduction Act of 1995
FDA has tentatively concluded that there are no new collections of
information in this draft guidance. This draft guidance refers to
previously approved collections of information found in the FD&C Act
and FDA regulations. These collections of information are subject to
review by the Office of Management and Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501-3520). In accordance with the
Paperwork Reduction Act, if FDA's tentative conclusion changes, prior
to publication of any final guidance document FDA intends to solicit
public comment and obtain OMB approval for any information collections
recommended in this guidance that are new or that would represent
material modifications to those previously approved collections of
information found in FDA regulations or guidances.
The collections of information in 21 CFR part 314 (new drug
applications) have been approved under OMB control number 0910-0001;
the collections of information in 21 CFR part 601 (biologics license
applications) have been approved under OMB control number 0910-0338;
the collections of information in 21 CFR part 207 (domestic and foreign
facility registration, including assignment of an NDC) have been
approved under OMB control number 0910-0045; the collections of
information in 21 CFR part 1 (general enforcement regulations) have
been approved under OMB control number 0910-0046; the collections of
information in 21 CFR part 201 (labeling) have been approved under OMB
control number 0910-0572; the collections of information pertaining to
current good manufacturing practice requirements for finished
pharmaceuticals and combination products under 21 CFR parts 4, 210,
211, 610, and 680 have been approved under OMB control numbers 0910-
0139 and 0910-0834; and the collections of information pertaining to
suspect product identification and notification under section 582 of
the FD&C Act have been approved under OMB control number 0910-0806.
IV. Electronic Access
Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, or https://www.regulations.gov.
Dated: December 11, 2019.
Brett P. Giroir,
Acting Commissioner of Food and Drugs.
[FR Doc. 2019-27475 Filed 12-18-19; 8:45 am]
BILLING CODE 4164-01-P