[Federal Register Volume 82, Number 119 (Thursday, June 22, 2017)]
[Notices]
[Pages 28493-28496]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12641]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-3615]


Administering the Hatch-Waxman Amendments: Ensuring a Balance 
Between Innovation and Access; Public Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
announcing the following meeting: ``The Hatch-Waxman Amendments: 
Ensuring a Balance Between Innovation and Access.'' This public meeting 
is intended to provide the public an opportunity to submit comments 
concerning administration of the Hatch-Waxman Amendments to the Federal 
Food, Drug, and Cosmetic Act (FD&C Act) to help ensure the intended 
balance between encouraging innovation in drug development and 
accelerating the availability to the public of lower cost alternatives 
to innovator drugs is maintained.

DATES: The meeting will be held on July 18, 2017, from 9 a.m. to 5 p.m. 
The deadline for submitting comments regarding this meeting is 
September 18, 2017.

ADDRESSES: The meeting will be held at the FDA White Oak Campus, 10903 
New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 
1503), Silver Spring, MD 20993. Entrance for the public meeting 
participants (non-FDA employees) is through Building 1, where routine 
security check procedures will be performed. For parking and security 
information, please refer to http://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 September 18, 2017. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of September 18, 2017. 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:

[[Page 28494]]

     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-2017-N-3615 for ``Administering the Hatch-Waxman Amendments: 
Ensuring a Balance Between Innovation and Access; Public Meeting; 
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 
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.gpo.gov/fdsys/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: Philip Bonforte, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 1668, Silver Spring, MD 20993, 240-402-
6980, email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    With the Drug Price Competition and Patent Term Restoration Act of 
1984 (Pub. L. 98-417) (Hatch-Waxman Amendments), Congress intended to 
strike a balance between encouraging innovation in drug development and 
accelerating the availability to the public of lower cost alternatives 
to innovator drugs. See H.R. Rep. No. 98-857 (Part I), 98th Cong, 2d 
Sess. At 14-15 (1984), reprinted in 1984 U.S.C.C.A.N. 2647-48; see 
also, e.g., Teva Pharmaceutical Industries Ltd. v. Crawford, 410 F.3d 
51, 54 (D.C. Cir. 2005). To provide incentives intended to encourage 
the development of innovative new drugs and new uses of approved drugs, 
the Hatch-Waxman Amendments provided sponsors of innovator drugs with 
exclusivity and protections based on patent listings that protect 
certain aspects of innovator drugs from generic competition for certain 
periods of time. To ensure the availability of generic drugs, the 
Hatch-Waxman Amendments created an abbreviated new drug application 
(ANDA) process that allows sponsors of generic drugs to rely on the 
Agency's finding of safety and effectiveness for innovator drugs in 
seeking approval of their generic products after patent or marketing 
exclusivity protections held by the innovator expire or are otherwise 
removed.
    FDA's generic drug program has dramatically expanded access to 
quality, affordable generic medicines. According to the IMS Institute 
for Healthcare Informatics, generic drugs saved the U.S healthcare 
system $1.68 trillion from 2005-2014.\1\
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    \1\ IMS Health Institute for Healthcare Informatics (April 
2015), available at http://www.imshealth.com/en/thought-leadership/quintilesims-institute/reports.
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    Over the past several years, the Agency has undertaken major 
initiatives to expand access to quality, affordable generic medicines. 
For example, pursuant to the Generic Drug User Fee Amendments of 2012 
(GDUFA I), FDA modernized the ANDA review program, and adopted metric 
goals to promote timely and predictable ANDA review. As a result, in 
Fiscal Year 2016, combined ANDA approvals and tentative approvals 
reached record highs. Pursuant to the proposed GDUFA II,\2\ FDA would 
further enhance the ANDA review program by clarifying regulatory 
expectations early in product development, helping applicants develop 
more complete submissions, and giving applicants more opportunities to 
address deficiencies within a review cycle, all with the goal of 
reducing the number of review cycles necessary to obtain ANDA approval.
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    \2\ GDUFA Reauthorization Performance Goals and Program 
Enhancements Fiscal Years 2018-2022 (October 2016), available at 
https://www.fda.gov/downloads/forindustry/userfees/genericdruguserfees/ucm525234.pdf.
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    The development and approval of an innovator drug, and the 
subsequent approval and marketing of a generic version, together make 
up the life cycle of that drug product as contemplated by the Hatch-
Waxman Amendments.
    At the front end of the life cycle, innovation in drug products--
including improvements to approved innovator drug products--provides 
life-changing and oftentimes life-saving therapeutic benefits to 
patients. In enacting the Hatch-Waxman Amendments, Congress recognized 
the importance of providing incentives to develop new products, and

[[Page 28495]]

new conditions of use for approved products. To further incentivize 
innovation, Congress subsequently established additional incentives in 
the form of exclusivity periods for drug products studied in pediatric 
populations, rare diseases, and new antibiotic treatments. Congress 
also provided a period of 180-day exclusivity for certain first generic 
applications as an incentive for generic manufacturers to challenge 
patents on innovator drugs that might otherwise prevent approval or 
delay generic entry into the market. These exclusivities, which are 
generally designed to reward sponsors with finite periods of limited or 
no generic or follow-on competition, were intended to expand the 
availability of safe and effective medicines for which insufficient or 
no treatment previously existed or to encourage generic drug 
development that might not have been profitable otherwise.
    In some cases, however, the legal framework surrounding these 
exclusivities may have been applied to delay generic competition to an 
extent that may not have been intended by the Hatch-Waxman Amendments, 
and in ways that may not serve the public health. Relatedly, certain 
elements of the approval process for both innovator and generic drugs 
have been used in ways that may (depending on the circumstances) 
inappropriately hinder generic competition. For example, innovators in 
some cases have made late changes in patent use codes that create new 
obstacles to previously acceptable labeling carve-outs. The entry of 
generic products to the marketplace is also affected by factors 
external to regulation under the FD&C Act--e.g., the outcome of private 
party patent litigation, and commercial decisions not to market 
approved innovator or generic products. In other cases, restrictions on 
the distribution of innovator drug products, whether voluntarily 
adopted by the innovator or imposed as a requirement of FDA regulation, 
have prevented developers from accessing the product samples needed for 
testing to support ANDAs or other follow-on applications.
    FDA will hold a public meeting on July 18, 2017, 9 a.m. to 5 p.m., 
to provide an opportunity for all interested stakeholders to submit 
comments concerning the appropriate balance between encouraging 
innovation in drug development and accelerating the availability to the 
public of lower cost alternatives to innovator drugs.
    The format of the meeting involves presentations from the public 
only. The Agency will not be inviting specific presenters; rather, with 
this document, FDA is soliciting presentations from interested 
stakeholders. FDA also invites interested persons to submit written 
comments to the docket on the topics described in section II.

II. Topics for This Public Meeting

    FDA is soliciting input from the public concerning how best to 
preserve the balance Congress intended to strike in the Hatch-Waxman 
Amendments between encouraging innovation in drug development and 
accelerating the availability to the public of lower cost alternatives 
to innovator drugs. Preserving this balance is critical to the public 
health, and innovators, generic drug manufacturers, and FDA (among 
others) all have a role to play in maintaining it. This public meeting 
is part of an effort to create a broader understanding of the interplay 
between the existing legal and regulatory framework, available 
incentives and marketplace practices, and consumer access to generic 
drugs.
    The Agency welcomes any relevant information that stakeholders wish 
to share. We are particularly interested in stakeholder input on the 
following questions:
    1. How has the balance struck in the Hatch-Waxman Amendments been 
affected by practices and trends related to the following:
    a. Exclusivity periods,
    b. Patents (including patent listing procedures),
    c. Innovator drug product labeling,
    d. Post-approval changes to innovator drug products, e.g., 
reformulations, and
    e. Other regulatory processes, including the citizen petition 
process?
    2. The drugs described in more than half of all FDA-approved ANDAs 
are never marketed, marketed only after a substantial delay after 
approval, or marketed only intermittently. Such failures to market 
contribute to drug shortages, and hinder consumer access to approved 
products. What marketplace dynamics dis-incentivize the marketing of 
approved generic products? What should FDA do, within its statutory 
authority, to help more approved generics reach consumers?
    3. For approximately 10 percent of all innovator drugs, patent and 
exclusivity protections have expired, but FDA has not received an ANDA. 
Are there market niches where the Hatch-Waxman Amendments incentives to 
develop an ANDA are insufficient? Similarly, are there niches where the 
incentives are insufficient to seek new drug approval of a marketed 
unapproved drug product that in turn could serve as a Reference Listed 
Drug? What should FDA do, consistent with its legal authority, to 
encourage submission development in any such market niches?
    4. The statutory requirement that Risk Evaluation and Mitigation 
Strategies (REMS) that include elements to assure safe use (ETASU) be 
implemented through a ``single shared system'' relies on brand and 
generic companies agreeing on such a system before generic drugs may 
come to market. In some cases, challenges in reaching such an agreement 
between the parties may cause delays to generic competition. How should 
FDA apply its statutory authority to waive this requirement to 
implement a ``single shared system,'' or develop other administrative 
tools, to avoid these delays?
    5. Restrictions on distribution, either required by innovators or 
as part of a REMS ETASU, can prevent generic companies from obtaining 
drug products for bioequivalence and other testing to support ANDA 
submissions. FDA published a draft guidance for industry, entitled 
``How to Obtain a Letter from the Food and Drug Administration Stating 
That Bioequivalence Study Protocols Contain Safety Protections 
Comparable to Applicable Risk and Evaluation Mitigation Studies for 
Reference Listed Drugs,'' in December 2014. Despite this draft 
guidance, generic companies have reported continuing difficulties 
obtaining sufficient samples of drug products for testing. What 
additional actions should FDA take, within its legal authority, to 
promote access to these drug products for generic companies seeking to 
conduct studies required to support ANDA submissions?
    6. What other elements of drug product development, regulation, and 
marketing have the potential to disrupt the Hatch-Waxman Amendments' 
balance between innovation and generic availability, and how should the 
Agency and other stakeholders address them?
    Registration and Requests for Oral Presentations: Send registration 
information (including name, title, firm name, address, telephone, 
email address, and fax number), and written material and requests to 
make oral presentations, to the contact person by July 3, 2017.
    If you need special accommodations due to a disability, please 
contact Philip Bonforte (see FOR FURTHER INFORMATION CONTACT) at least 
7 days in advance.
    Transcripts: Please be advised that as soon as a transcript is 
available, it will be accessible at https://www.regulations.gov. It may 
be viewed at the Dockets Management Staff (see ADDRESSES).


[[Page 28496]]


    Dated: June 14, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-12641 Filed 6-21-17; 8:45 am]
BILLING CODE 4164-01-P