[Federal Register Volume 85, Number 23 (Tuesday, February 4, 2020)]
[Notices]
[Pages 6203-6205]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-02101]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-6050]


Food and Drug Administration/Federal Trade Commission Workshop on 
a Competitive Marketplace for Biosimilars; Public Workshop; Request for 
Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of workshop; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we), in 
collaboration with the Federal Trade Commission (FTC), is announcing a 
public workshop on March 9, 2020, ``FDA/FTC Workshop on a Competitive 
Marketplace for Biosimilars.'' The purpose of the public workshop is to 
discuss FDA and FTC's collaborative efforts to support appropriate 
adoption of biosimilars, discourage false or misleading communications 
about biosimilars, and deter anticompetitive behaviors in the biologic 
product marketplace.

DATES: The public workshop will be held on March 9, 2020, from 9 a.m. 
to 5 p.m. Persons seeking to speak at the public workshop must register 
by February 24, 2020. Persons seeking to attend but not speak at the 
public workshop must register by March 4, 2020. Section III provides 
attendance and registration information. Electronic or written comments 
will be accepted until April 9, 2020.

ADDRESSES: The public workshop will be held at FDA White Oak Campus, 
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room 
(Rm. 1503A), Silver Spring, MD 20993-0002. Entrance for the public 
workshop participants (non-FDA employees) is through Building 1 where 
routine security check procedures will be performed. For parking and 
security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    You may submit comments as follows. Please note that late, untimely 
filed comments will not be considered. Electronic comments must be 
submitted on or before April 9, 2020. The https://www.regulations.gov 
electronic filing system will accept comments until 11:59 p.m. Eastern 
Time at the end April 9, 2020. Comments received by mail/hand delivery/
courier (for written/paper submissions) will be considered timely if 
they are postmarked or the delivery service acceptance receipt is on or 
before that date.

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-N-6050 for ``FDA/FTC Workshop on a Competitive Marketplace for 
Biosimilars.'' 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 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.'' FDA will review 
this copy, including the claimed confidential information, in its 
consideration of comments and will share it with FTC. 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.

FOR FURTHER INFORMATION CONTACT: Sandra Benton, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New

[[Page 6204]]

Hampshire Ave., Bldg. 75, Rm. 6522, Silver Spring, MD 20993-0002, 301-
796-1042, email: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA, in collaboration with FTC, is announcing the following public 
workshop entitled ``FDA/FTC Workshop on a Competitive Marketplace for 
Biosimilars.'' The purpose of the public workshop is to discuss FDA and 
FTC's collaborative efforts to support appropriate adoption of 
biosimilars, discourage false or misleading communications about 
biosimilars, and deter anticompetitive behaviors in the biologic 
product marketplace.
    FDA, an agency within the U.S. Department of Health and Human 
Services, protects the public health by assuring the safety, 
effectiveness, and security of human and veterinary drugs, vaccines, 
and other biological products for human use, and medical devices. The 
Agency is also responsible for the safety and security of our nation's 
food supply, cosmetics, dietary supplements, and products that emit 
electronic radiation, and for regulating tobacco products. Congress has 
given FDA, as part of the Agency's mission to promote and protect the 
public health, responsibility for implementing laws intended to strike 
a balance between encouraging and rewarding innovation in drug and 
biological product development and facilitating robust and timely 
market competition for drugs and biological products.
    FDA regulates biological products under the Public Health Service 
Act (PHS Act) (see 42 U.S.C. 262) and the Food, Drug, and Cosmetic Act 
(21 U.S.C. 355). This includes review and approval of biosimilar and 
interchangeable products pursuant to an abbreviated licensure pathway 
added to the PHS Act in the Biologics Price Competition and Innovation 
Act of 2009 (BPCI Act),\1\ which allows an applicant seeking licensure 
of a proposed biosimilar or interchangeable product to leverage FDA's 
previous determination of safety and effectiveness for a reference 
product licensed under section 351(a) of the PHS Act provided the 
sponsor can demonstrate that the biosimilar or interchangeable product 
meets the statutory standards for approval. The BPCI Act was enacted 
with the intent to balance innovation and consumer interests.\2\ FDA 
has and will continue to play a critical role in facilitating increased 
access to biosimilars, by supporting robust and timely competition 
through, among other things, the efficient review of applications for 
biosimilar and interchangeable products, which in turn may help enhance 
patient access and reduce cost burdens on patients and our healthcare 
system, in addition to helping to ensure the United States remains a 
driving force in medical innovation. Part of that role includes helping 
to ensure communication of truthful, nonmisleading, and balanced 
information about biological products, through FDA's oversight of 
prescription drug labeling and advertisements by drug manufacturers, 
packers and distributors and those acting on their behalf, and through 
FDA's own communications. This workshop will help to advance these 
important FDA priorities.
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    \1\ Sections 7001 through 7003 of the Patient Protection and 
Affordable Care Act (ACA) (Pub. L. 111-148). See also Biosimilars 
Action Plan, https://www.fda.gov/media/114574/download.
    \2\ Id., section 7001(b) of the ACA.
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    FTC is an independent agency charged by Congress with protecting 
the interests of consumers by enforcing competition and consumer 
protection laws. (See Federal Trade Commission Act, 15 U.S.C. 41-58.) 
It exercises primary responsibility for civil antitrust enforcement in 
the pharmaceutical industry. (For a summary of FTC's antitrust actions 
in the pharmaceutical industry, see https://www.ftc.gov/system/files/attachments/competition-policy-guidance/overview_pharma_june_2019.pdf.) 
FTC also protects consumers by enforcing laws and rules that promote 
truth in advertising and fair business practices. FTC has substantial 
experience evaluating the generic drug and biosimilar marketplaces.
    FTC vigorously promotes competition in the healthcare industry 
through enforcement, study, and advocacy. Competition in healthcare 
markets benefits consumers by helping to: (1) Control costs and prices; 
(2) improve quality of care; (3) promote innovative products, services, 
and delivery models; and (4) expand access to healthcare goods and 
services. One of the FTC's long-standing core missions is to ensure 
advertising is truthful and not misleading. This allows consumers to 
make well-informed decisions about how best to use their resources and 
promotes the efficient functioning of market forces by encouraging the 
dissemination of accurate information. As addressed below, this 
proposed workshop is consistent with these FTC priorities.
    As the marketplace of biological products continues to expand and 
evolve, FDA and FTC expect an increase in promotional activities 
involving reference products and biosimilar and interchangeable 
products. FDA, in collaboration with FTC, supports and encourages 
competitive markets for biological products. Supporting a competitive 
marketplace for biological products including biosimilar and 
interchangeable products, is essential for patient access to medicines 
and reducing healthcare costs. Biological products play a critical role 
in the treatment of many serious illnesses, including rare genetic 
disorders, autoimmune diseases, and cancer. For many of these 
conditions, there are no treatment alternatives other than biological 
products.
    Both FDA and FTC have serious concerns about false or misleading 
communications regarding reference products and biosimilar or 
interchangeable products, and the potential negative effects of such 
communications on public health and competition. False or misleading 
comparisons of reference products and biosimilar or interchangeable 
products may constitute unfair or deceptive practices that undermine 
confidence in biosimilar and interchangeable products. Both agencies 
want to ensure that healthcare professionals and patients receive 
truthful and nonmisleading information about biological products.
    This public workshop is a component of FDA's broader effort to 
facilitate the growth of a competitive market for biological products. 
In July 2018, FDA issued its Biosimilars Action Plan (see https://www.fda.gov/media/114574/download), which focuses on four areas of FDA 
activities: (1) Improving the efficiency of the biosimilar and 
interchangeable product development and approval process; (2) 
maximizing scientific and regulatory clarity for the biosimilar product 
development community; (3) developing effective communications to 
improve understanding of biosimilars among patients, clinicians, and 
payors; and (4) supporting market competition by reducing gaming of FDA 
requirements or other attempts to unfairly delay competition. This 
joint FDA and FTC workshop furthers the activities set forth in the 
Biosimilars Action Plan.

II. Topics for Discussion at the Public Workshop

    FDA and FTC are holding this public workshop to engage with 
stakeholders about certain aspects of a competitive market for 
biological products,

[[Page 6205]]

including biosimilars and interchangeable products, and to discuss the 
important impact these products have on public health. This includes:
     U.S. Biosimilar Markets and FDA Approval Process;
     Enforcement Activities by FDA and FTC;
     The Benefits of Competition; and
     Improving Stakeholder Engagement: Education and Access.
    FDA and FTC also encourage comments from stakeholders and the 
public relating to steps FDA and FTC can take to facilitate a 
competitive market for biological products.

III. Participating in the Public Workshop

    The FDA Conference Center at the White Oak location is a Federal 
facility with security procedures and limited seating. Attendance will 
be free and on a first-come, first-served basis. An agenda for the 
workshop and any other background materials will be made available 5 
days before the workshop at https://www.fda.gov/drugs/news-events-human-drugs/public-workshop-fdaftc-workshop-competitive-marketplace-biosimilars-03092020-03092020. If you need special accommodations 
because of a disability, please contact Sandra Benton (see FOR FURTHER 
INFORMATION CONTACT) at least 7 days before the workshop.
    Registration and Requests for Open Public Workshop Speaker Slots. 
For those interested in participating as an Open Public Workshop 
speaker, please register at https://www.eventbrite.com/e/86931096249 as 
``In-person Open Public Workshop presenter.'' Open Public Workshop 
registrations are due by February 24, 2020; however, if time is 
available, you may sign up as an Open Public Workshop speaker the day 
of the meeting. Time and space are limited and available on a first-
come, first-served basis. Open Public Workshop speakers may be assigned 
no more than 5 minutes for their presentation and will deliver oral 
testimony only (no accompanying slide deck).
    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 presentations and request time for a 
joint presentation. All requests to make oral presentations must be 
received by February 24, 2020. No commercial or promotional material 
will be permitted to be presented or distributed at the public 
workshop.
    In-Person Attendance: For those who would like to attend in person, 
but who are not participating in the Open Public Workshop, please 
register at https://www.eventbrite.com/e/86931096249 as ``In-person 
attendee--no participation.'' You may choose not to register; however, 
seating is limited, and space will be available on a first-come, first-
served basis.
    Persons attending FDA's workshops are advised that FDA is not 
responsible for providing access to electrical outlets.
    Streaming Webcast of the Public Workshop: For those unable to 
attend in person, FDA will provide a live webcast of the workshop. To 
join the workshop via the webcast, please go to https://www.fda.gov/drugs/news-events-human-drugs/public-workshop-fdaftc-workshop-competitive-marketplace-biosimilars-03092020-03092020 for the webcast 
address. Please register at https://www.eventbrite.com/e/86931096249 as 
``online (webcast only).''
    Media: Please register at https://www.eventbrite.com/e/86931096249 
as ``Media'' by March 4, 2020.
    Transcripts: Please be advised that when a transcript of the public 
workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff 
(see ADDRESSES).

    Dated: January 29, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-02101 Filed 2-3-20; 8:45 am]
 BILLING CODE 4164-01-P