[Federal Register Volume 83, Number 175 (Monday, September 10, 2018)]
[Notices]
[Pages 45640-45642]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-19612]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3272]


Identifying the Root Causes of Drug Shortages and Finding 
Enduring Solutions; 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, the Agency, or we) is 
announcing a public meeting entitled ``Identifying the Root Causes of 
Drug Shortages and Finding Enduring Solutions.'' The purpose of the 
meeting is to give stakeholders, including health care providers, 
patients, manufacturers, wholesalers, pharmacists, pharmacy benefit 
managers, veterinarians, public and private insurers, academic 
researchers, and the public, the opportunity to provide input on the 
underlying systemic causes of drug shortages, and make recommendations 
for actions to prevent or mitigate drug shortages. Members of Congress 
have asked the Agency to examine the root causes and drivers of these 
shortages, and to recommend measures that will provide more enduring 
solutions. To this end, the Commissioner has convened an inter-Agency 
task force of senior Federal officials of FDA, the Centers for Medicare 
& Medicaid Services, the Department of Veterans Affairs, and the 
Department of Defense. After receiving input from stakeholders, the 
task force intends to provide a report to Congress regarding the root 
causes of drug shortages. The report will also include recommendations 
regarding new authorities FDA or other Federal agencies could use to 
help provide enduring solutions to shortages.

DATES: The public meeting will be held on November 27, 2018, from 8:30 
a.m. to 4:30 p.m. Submit either electronic or written comments on this 
public meeting by January 11, 2019. See the SUPPLEMENTARY INFORMATION 
section for registration date and information.

ADDRESSES: The public meeting will be held at the Washington Marriott 
at Metro Center, 775 12th St. NW, Washington, DC 20005. The hotel's 
phone number is 202-737-2200.
    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 January 11, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of January 11, 2019. 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-2018-N-3272 for ``Identifying the Root Causes of Drug Shortages and 
Finding Enduring Solutions.'' 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: Michie Hunt, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire

[[Page 45641]]

Ave., Bldg. 51, Rm. 6153, Silver Spring, MD 20993, 301-796-3504.

SUPPLEMENTARY INFORMATION: 

I. Background

    Drug shortages are among the greatest challenges health care 
providers and patients face. These shortages can affect treatment 
options and require practitioners to make difficult decisions that can 
compromise care, such as rationing supplies or using less desirable, 
but more readily available, alternative therapies. FDA has acted within 
its statutory authority to prevent and mitigate drug shortages. By 
working with industry and other parties, the Agency has helped to 
steadily reduce the number of new shortages since a peak of 251 new 
shortages occurred in 2011, as detailed in the Agency's ``Report on 
Drug Shortages for Calendar Year 2017,'' which is available at https://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM610662.pdf.
    Despite this success in preventing or mitigating individual cases, 
more can and must be done to better understand and address the 
underlying systemic factors that are leading to shortages of medically 
necessary drugs. Members of Congress have asked the Agency to examine 
the root causes and drivers of these shortages, and to recommend 
measures that will provide more enduring solutions. To this end, the 
Commissioner has convened an inter-agency task force of senior federal 
officials of FDA, the Centers for Medicare & Medicaid Services, the 
Department of Veterans Affairs, and the Department of Defense. After 
receiving input from stakeholders, the task force intends to provide a 
report to Congress regarding the root causes of drug shortages. The 
report will also include recommendations regarding new authorities FDA 
or other federal agencies could use to help provide enduring solutions 
to shortages.

II. Topics for Discussion at the Public Meeting

    We are soliciting input from stakeholders concerning the adverse 
consequences of drug shortages, the underlying systemic causes and 
drivers of these shortages, and the policies and strategies that may 
help to prevent or mitigate them. We welcome any relevant information 
that stakeholders wish to share, as all factors contributing to 
shortages are matters of concern. We are particularly interested in 
stakeholder input in the following areas:

A. Assessing the Adverse Consequences of Drug Shortages to Patients, 
Health Care Providers, and the Drug Supply Chain

    1. Drug Shortages' Impact on Patients
    a. What clinical impacts have patients experienced: e.g., adverse 
events, treatment delays, accelerated disease progression, or worsened 
outcomes due to patients' to using less effective or less safe 
alternatives?
    b. What economic impacts have patients affected by drug shortages 
experienced?
    c. Do drug shortages affect patients disproportionately by 
geographic region, age, disease or condition, socioeconomic status, or 
other factors? Are there specific times of year or classes of drugs 
that see episodic, more frequent or more severe shortages? If so, why 
does this happen?
    2. Drug Shortages Impact on Health Care Providers
    a. What economic impacts (including increased inventory management 
costs, substitution of more expensive drugs for drugs in shortage, and 
increased liability from adverse events) have health care providers, 
including veterinarians, experienced because of drug shortages?
    b. Do the adverse consequences of shortages affect providers 
disproportionately by, for example, geographic region, clinical area, 
or other characteristics?
    3. Drug Shortages' Impact on the Supply Chain
    a. What economic effects have shortages had on key links in the 
drug supply chain: e.g., wholesalers, distributors, and pharmacies?
    b. Have certain links in the supply chain been disproportionately 
affected by shortages? If so, which ones?
    4. Do available data accurately capture the differences among 
shortages (e.g., their severity and duration) that may affect their 
clinical and economic adverse consequences? If not, what additional 
data would be needed to better capture these differences?

B. Identifying the Root Causes and Drivers of Drug Shortages

    1. What factors affect the likelihood, severity, and duration of 
shortages? Are these factors mostly related to raw materials, 
management, and resilience of production facilities, or other factors 
such as contracting or market structure? Do they differ for various 
drugs?
    2. What government policies and regulations may contribute to drug 
shortages, and how could these be modified to prevent or limit impacts 
of drug shortages?
    3. How do manufacturers contribute to drug availability or 
shortages, including responses to shortages?
    a. What factors do generic and brand manufacturers consider when 
making decisions about whether to seek approval for certain drugs, to 
produce and market a drug for which they already hold an approved new 
drug application or abbreviated new drug application, or to discontinue 
marketing a drug? How do those decisions contribute (directly or 
indirectly) to shortages?
    b. How do manufacturers monitor for situations that may result in a 
drug shortage? Are there certain indicators that are monitored? If so, 
are the potential triggers the same for all drugs, for example brand 
and generic sterile injectable drugs?
    c. When manufacturers recognize a potential shortage, what options 
do they have for averting one? How easy or difficult is it to implement 
these options, and how costly is it to implement them? What is the 
impact of government policy or regulation on these options?
    d. What factors play a role in manufacturers' decisions to make 
capital investments to expand capacity or to modernize infrastructure?
    e. When manufacturers are remediating or upgrading a facility, how 
can shortages related to production slowdowns and shutdowns be avoided?
    4. Drug supply is controlled through contracts among manufacturers, 
distributors, and end users. What features of contracts used throughout 
the supply chain contribute to drug availability and shortages, 
including responses to shortages?
    a. What is the effect of duration and scope (how many and what 
types of drug products are covered by each contract, and whether non-
drug products are bundled into the contract), on drug availability or 
shortage?
    b. How commonly do these contracts include incentives such as 
contingency clauses, performance requirements, failure-to-supply 
clauses, or restrictions on limiting downstream price increases? How 
large are these incentives currently? Are there institutional or 
informational impediments limiting greater use of such incentives or 
performance clauses?
    c. What are the implications of markups on inventory management 
throughout the supply chain? How might these markups contribute to 
shortages, and to response to shortages?
    d. How have the characteristics of contracts, and markups at 
different points in the supply chain, changed over the past 15 years?

[[Page 45642]]

    e. What are the implications of these contracting provisions and 
their changes for the probability, severity, and duration of drug 
shortages?
    f. How much competition exists throughout the supply chain? Over 
the past 15 years, have there been challenges to competition and if so, 
what factors are responsible for these challenges? For example, has 
consolidation in different parts of the supply chain created market 
barriers to entry and reduced competition? If so, what effect has the 
reduction in competition had on drug shortages?

C. Identifying Strategies for Preventing or Mitigating Drug Shortages

    1. What policies could the Federal Government adopt, and what 
strategies could it implement, that would reduce the likelihood, 
severity, and duration of shortages? Would additional authorities be 
necessary or helpful? For example:
    a. Establish a list of ``essential medicines'' for use in 
preventing and mitigating shortages. If such a list were established, 
what should be the criteria for inclusion? And how should such a list 
be maintained and administered?
    b. Provide financial incentives, such as tax credits or revised 
reimbursement policies: e.g., to allow additional payments for drugs in 
or at risk of shortage or to encourage investment to expand 
manufacturing capacity or to modernize aging infrastructure, to enhance 
process capability and variability control, or to prevent manufacturing 
problems that affect product availability;
    c. Allow other entities (e.g., contract manufacturers) to fill gaps 
in supply;
    d. Require risk management plans to help manufacturers prepare to 
respond efficiently and effectively to potential shortages;
    e. Require the extension of expiration dates for drugs in shortage 
or at risk of shortage, where scientifically justified;
    f. Revise trade policies and authorities: e.g., to allow federal 
purchasers to buy imported drugs or raw materials to prevent or 
mitigate a shortage;
    g. Heighten scrutiny of proposed mergers and acquisitions that 
increase market concentration or the likelihood of shortages;
    h. Revise payment policies and authorities: e.g., that would be 
coupled with a requirement to establish contingency plans for supplying 
medicines that go into shortage; and
    i. Federal investment in production capacity for essential 
medicines directly related to national security, emergency 
preparedness, and defense.
    2. In designing new policies to prevent or mitigate shortages, how 
can the Federal Government avoid creating perverse incentives or 
negative cascading effects in the health care financing and delivery 
system? For example, how might changes to government payment and 
reimbursement affect the other sectors of the market?
    3. Are there lessons for the Federal Government, or practices that 
it can emulate, from strategies used to prevent or mitigate shortages 
in other commodity markets that face shortage issues?
    4. What challenges does the global nature of drug manufacturing and 
marketing pose for efforts to prevent shortages in the U.S. market?
    5. As drug shortages are a national problem, what are the sources 
of funding that can be applied to provide incentives to remedy the root 
causes?

III. Participating in the Public Meeting

    Registration: To register for the public meeting, please visit the 
following website: https://healthpolicy.duke.edu/events/drug-shortage-task-force. Please provide complete contact information for each 
attendee, including name, title, affiliation, address, email, and 
telephone. Registration is free and based on space availability, with 
priority given to early registrants. Persons interested in attending 
this public meeting must register by Wednesday, November 21, 2018, 
midnight Eastern Time. There will be no onsite registration. Early 
registration is recommended because seating is limited; therefore, FDA 
may limit the number of participants from each organization. 
Registrants will receive confirmation when they have been accepted. If 
you are unable to attend the meeting in person, you can register to 
view a live webcast of the meeting. The Duke-Margolis Center for Health 
Policy will post on its website if registration closes before the day 
of the public meeting.
    If you need special accommodations due to a disability, please 
contact Sarah Supsiri at the Duke-Margolis Center for Health Policy 
(phone: 202-791-9561, email: [email protected]) no later than 
November 20, 2018.
    Streaming webcast of the public workshop: This public workshop will 
be webcast live. Persons interested in viewing the live webcast may 
register ahead of the event by visiting https://healthpolicy.duke.edu/events/drug-shortage-task-force. The live webcast will also be 
available at the website above on the day of the event without pre-
registration. Archived video footage will be available at the Duke-
Margolis website following the workshop.
    Transcripts: Please be advised that as soon as a transcript of the 
public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff 
(see ADDRESSES). A link to the transcript will also be available on the 
internet at https://www.fda.gov/Drugs/DrugSafety/DrugShortages/default.htm.
    Other Issues for Consideration: A 1-hour lunch break is scheduled, 
but food will not be provided. There are multiple restaurants within 
walking distance of the Washington Marriott at Metro Center, 775 12th 
St. NW, Washington, DC 20005.
    All event materials will be provided to registered attendees via 
email prior to the workshop and will be publicly available at the Duke-
Margolis Center for Health Policy website at https://healthpolicy.duke.edu/events/drug-shortage-task-force.

    Dated: September 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-19612 Filed 9-7-18; 8:45 am]
BILLING CODE 4164-01-P