The document summarizes how the US government shutdown in January 2019 impacted operations at the FDA and activities related to drug and medical device development. It notes that some FDA activities could continue using carryover user fees, including reviewing certain submissions and advancing some policies. However, the FDA could not accept new application submissions requiring fees or conduct all planned activities like issuing some guidances. Key FDA divisions were impacted differently depending on their funding sources. The document aims to help biopharma clients understand how the shutdown affected FDA operations and timelines.

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Impact of the
Government
Shutdown on
Synchrogenix
clients
January 4, 2019Darshan Kulkarni Pharm.D, MS, Esq
VP Reg Strategy/Policy, Synchrogenix

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Start
• Effective December 22, 2018
• Affected a quarter of federal agencies (most had already been funded for FY 2019)
• Some 800,000 federal workers either furloughed or working without pay
• #FDA plans to use social media as a primary channel for communicating with the public through
this shutdown.
• #FDA retains limited carryover balances for 21st Century Cures and opioids funding. These
balances will only be spent on activities for which the funds are authorized.
• PHS Commissioned Corps are exempt from furlough and are reporting to duty
• FDA plans to create a new office to leverage cutting-edge science
• During a press conference on Wednesday Trump continued to press for $5.6 billion in funding for
border security as a condition for signing a funding bill and said that the shutdown could last "a
long time.“
• On Thursday, Nancy Pelosi (D-CA) took over as Speaker of the House and has said that House
Democrats will quickly pass legislation to end the shutdown, though the Senate is poised to reject
any legislation that does not have Trump's support.

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During the shutdown

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Research and Investigational Drugs
• FDA “[continues to] reviewing requests to conduct important clinical
research, issue guidance, other necessary activities to help patients
access new therapies and important generic and biosimilar treatment
options.”
• For many patients, access to an investigational drug may be their best or
even last chance for treatment. Our commitment to responding quickly to
these requests will not waiver despite a lapse in funding. These requests
will continue to be a top priority for us
• #FDA will also use carryover funding to support development of medical
products. This includes participating in pre-approval discussions with
sponsors seeking guidance on how to go forward with clinical research
and other ongoing discussions to help advance development programs.

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New Applications
• The #FDA can't collect FY 2019 user fee payments during the shutdown,
• Can't accept new applications for products under user fee programs: PDUFA, GDUFA, BsUFA,
MDUFA, ADUFA, AGDUFA.
• #FDA will not be able to accept any regulatory submissions for FY 2019 for new drugs, medical
devices, or biologics that require a fee payment and that are submitted during the lapse period,
unless the required user fee was paid before December 22, 2018.
• FDA carryover user-fee funds also allow the agency to continue work on existing user-fee related
applications.
• During the lapse period, for PDUFA products, FDA will accept new regulatory submissions for
which no fee is required. These types of submissions include INDs, annual reports, supplements
to NDAs and BLAs, submissions that fall within fee exemptions, and general correspondence.
This includes submissions that fall within the fee exemption for previously filed applications and
applications for which FDA has waived the application fee (e.g., small business waiver) and
NDAs or BLAs that only have orphan designated indications.
• PDUFA-covered products are products that would be approved under an NDA—including a
505B2 application—or a 351(a) BLA, medical gases that have been deemed to have NDAs
through the medical gas certification process outlined in sections 575 and 576 of the FDCA

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GDUFA
• FDA will not accept generic drug submissions that require payment
• New GDUFA submissions that'll be processed with carryover user fees include: CBE and prior
approval supplements, amendments, annual reports, applications for PET drugs, general
correspondence
• FDA will also be accepting Drug Master Files, including Type II Active Pharmaceutical Ingredient
(API) DMFs, to be referenced in generic drug applications. But, FDA can't conduct initial
completeness assessments on Type II API DMFs if the fee hasn’t been already paid.
• If a generic drug application references, of a fee (e.g., Abbreviated New Drug Applications
(ANDAs)) for the first time after Dec 22, 2018, a Type II API DMF for which the fee has not been
paid, then FDA will notify the applicant that the fee must be paid within 20 calendar days. If the
fee is not paid within 20 calendar days of that notice, FDA will not receive the application. At this
time, FDA has not determined what0 approach it will take if the 20 calendar day period expires
during the lapse period.
• Sponsors who haven’t paid GDUFA facility fees for FY19 shouldn’t remit payment during the
lapse period because FDA cannot accept the fees. Fees that are due during the lapse period
may be paid as soon as the lapse period ends.

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Biologics
• CBER will pause non-emergency work on whole blood, blood
components for transfusion, allergenic extracts and HCT/Ps regulated
solely under sec. 361 of the PHSA since it cannot be conducted with
carryover user fee funding.
• The 30-day review clock for any pending, non-emergency IND for a
medical product that is not covered by a user fee program will be
suspended during the lapse period. The clock will resume when the
lapse period is over.
• New emergency INDs and IND amendments that relate to the safety of
individuals who are participating in clinical trials will continue to be
reviewed during the government shutdown, even for products that are
not covered by a user fee program.

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CDER
• Pausing all OTC monograph drug activities.
• The 30-day review clock for any pending, non-emergency IND for a
medical product that is not covered by a user fee program will be
suspended during the lapse period. The clock will resume when the
lapse period is over.
• New emergency INDs and IND amendments that relate to the safety of
individuals who are participating in clinical trials will continue to be
reviewed during the government shutdown, even for products that are
not covered by a user fee program.

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Tobacco & E-cigarettes
• With carryover user fees, @FDATobacco will also continue carrying out
the Tobacco Control Act, overseeing the manufacturing, distribution, and
marketing of tobacco products, and efforts to combat the epidemic of
youth e-cigarette use and access to all tobacco products.
• FDA is concerned that some e-cig companies are already appearing to
back away from commitments made to FDA and the public. Com.
Gottlieb is writing CEOs of e-cig manufacturers asking them to meet to
discuss commitments they made last month, and why some are
changing course.
• Inquiries and/or investigations of e-cig makers related to marketing
activities and other product-related issues

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Importation
• Entry review of all products to determine the potential risk to health (for
example, to determine whether the product poses an imminent threat to
health/life).
• Examination - including sampling - of products that may pose a high risk
to health will be conducted
• Detention of product, including products subject to detention without
physical examination, if product may pose a high risk to health will also
occur.
• Mail Facility operations; examination of packages to detect counterfeit
and other products that may pose high risk to health shall also happen.

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What Wont Happen
• Carryover user-fees support important actions, including developing guidance and
advancing policies that further FDA’s regulatory oversight of medical products and
animal drugs. (New guidances have been issued since the lapse in funding)
• But, does limit many medical product related activities, including the development of certain
guidances.
• FDA also cannot accept new applications for medical products that require the payment
of a user fee.
• FDA won't conduct initial completeness assessments on Type II API DMFs for which
the fee hasn't been paid and these new DMFs will not be placed on the Available for
Reference List
• FDA will not accept applications for products that would be approved under an ANDA or
351(k) biosimilar BLA, nor OTC monograph drugs, although OTC products approved
under NDAs are PDUFA-covered (and potentially accepted).
• The FDA has changed its internal travel policy in an effort to make the government
shutdown less burdensome on inspectors who are working without pay to oversee
critical functions like food and pharmaceutical safety.

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Outstanding questions FDA intends to respond to
• Conduct routine inspections

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Lapse Guidances
• https://www.fda.gov/AboutFDA/WorkingatFDA/ucm629114.htm#messag
es

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Questions?Questions?
16
For more information about how the shutdown affects your company.
Email: Darshan.Kulkarni@Synchrogenix.com
Phone: 302.892.4800