81 FR 71510 - Substitutability of Generic Drugs: Perceptions and Reality; Public Workshop

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 200 (October 17, 2016)

Page Range		71510-71511
FR Document		2016-25004

The Food and Drug Administration (FDA), in collaboration with the Johns Hopkins University Center of Excellence in Regulatory Science and Innovation, is announcing a public workshop entitled ``Substitutability of Generic Drugs: Perceptions and Reality.'' The objective of this workshop is to discuss FDA and industry practices related to postmarket surveillance of generic drugs, postmarket generic drug research activities, public perceptions of generic drug quality and effectiveness, and verification of therapeutic equivalence of generic drugs. This workshop will also give stakeholders, including scientists from government, academia, and industry, patient advocacy groups, clinicians, pharmacists, and the general public an opportunity to provide their insights on future research needs in postmarket surveillance of generic drugs.

Federal Register, Volume 81 Issue 200 (Monday, October 17, 2016)

[Federal Register Volume 81, Number 200 (Monday, October 17, 2016)]
[Notices]
[Pages 71510-71511]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-25004]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]


Substitutability of Generic Drugs: Perceptions and Reality; 
Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA), in collaboration with 
the Johns Hopkins University Center of Excellence in Regulatory Science 
and Innovation, is announcing a public workshop entitled 
``Substitutability of Generic Drugs: Perceptions and Reality.'' The 
objective of this workshop is to discuss FDA and industry practices 
related to postmarket surveillance of generic drugs, postmarket generic 
drug research activities, public perceptions of generic drug quality 
and effectiveness, and verification of therapeutic equivalence of 
generic drugs. This workshop will also give stakeholders, including 
scientists from government, academia, and industry, patient advocacy 
groups, clinicians, pharmacists, and the general public an opportunity 
to provide their insights on future research needs in postmarket 
surveillance of generic drugs.

DATES: The public workshop will be held on November 18, 2016, from 8:30 
a.m. to 4:30 p.m.

ADDRESSES: The public workshop will be held at FDA's White Oak Campus, 
10903 New Hampshire Ave., Building 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

[[Page 71511]]

security check procedures will be performed. For parking and security 
information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

FOR FURTHER INFORMATION CONTACT: Audrey Thomas, Office of Regulatory 
Science and Innovation, Office of the Chief Scientist, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4220, Silver 
Spring, MD 20993-0002, 301-796-3520, [email protected].

SUPPLEMENTARY INFORMATION: The purpose of this public workshop is to 
provide an opportunity for stakeholders, including scientists from 
government, academia, and industry, patient advocacy groups, 
clinicians, pharmacists, and the general public to discuss marketed 
generic drugs. Generic drugs account for 88 percent of prescriptions in 
the United States. In light of the significant contributions of generic 
drugs to public health, it is important that tools are developed to 
monitor marketed generic drugs to ensure that they have the same safety 
and effectiveness as their reference listed drug. Specifically, this 
workshop will include presentations on: (1) Current generic drug 
surveillance practices at FDA and in industry, (2) public perception of 
generic drug quality and effectiveness, (3) generic drug substitution 
studies in patients, and (4) development of methods and tools to 
conduct postmarket surveillance of generic drugs. The workshop will 
include four panel sessions for interaction and discussion among the 
speakers and attendees.
    Agenda: The agenda is available at http://www.fda.gov/scienceresearch/specialtopics/regulatoryscience/ucm521545.htm.
    Registration: There is no registration fee to attend this public 
workshop. Seats are limited and registration will be on a first-come, 
first-served basis. Advance registration is required and is online only 
at http://www.fda.gov/scienceresearch/specialtopics/regulatoryscience/ucm521545.htm. There will be no day-of, onsite registration.
    Streaming Webcast of the Public Workshop: This public workshop will 
also be Webcast. There is no registration fee for access to the 
workshop via the Webcast, but registration is still required. 
Information regarding registration and access to the Webcast link is 
available at http://www.fda.gov/scienceresearch/specialtopics/regulatoryscience/ucm521545.htm. If you have never attended a Connect 
Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a 
quick overview of the Connect Pro program, visit http://www.adobe.com/go/connectpro_overview. (FDA has verified these Web site addresses, but 
FDA is not responsible for any subsequent changes to the Web sites 
after this document publishes in the Federal Register.)
    Accommodations: Attendees are responsible for their own hotel 
accommodations. If you need special accommodations while at FDA's White 
Oak Campus due to a disability, please contact Shari Solomon at 
[email protected] at least 7 days in advance.

    Dated: October 11, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-25004 Filed 10-14-16; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 200 / Monday, October 17, 2016 / Notices 71511

security check procedures will be you have never attended a Connect Pro Under section 529 of the FD&C Act (21
performed. For parking and security event before, test your connection at U.S.C. 360ff), which was added by
information, please refer to http:// https://collaboration.fda.gov/common/ FDASIA, FDA will award priority
www.fda.gov/AboutFDA/ help/en/support/meeting_test.htm. To review vouchers to sponsors of rare
WorkingatFDA/BuildingsandFacilities/ get a quick overview of the Connect Pro pediatric disease product applications
WhiteOakCampusInformation/ program, visit http://www.adobe.com/ that meet certain criteria. FDA has
ucm241740.htm. go/connectpro_overview. (FDA has determined that EXONDYS 51
FOR FURTHER INFORMATION CONTACT: verified these Web site addresses, but (eteplirsen), manufactured by Sarepta
Audrey Thomas, Office of Regulatory FDA is not responsible for any Therapeutics, meets the criteria for a
Science and Innovation, Office of the subsequent changes to the Web sites priority review voucher. EXONDYS 51
Chief Scientist, Food and Drug after this document publishes in the (eteplirsen) is indicated for the
Administration, 10903 New Hampshire Federal Register.) treatment of Duchenne muscular
Ave., Bldg. 1, Rm. 4220, Silver Spring, Accommodations: Attendees are dystrophy (DMD) in patients who have
MD 20993–0002, 301–796–3520, responsible for their own hotel a confirmed mutation of the DMD gene
Audrey.Thomas@fda.hhs.gov. accommodations. If you need special that is amenable to exon 51 skipping.
accommodations while at FDA’s White For further information about the Rare
SUPPLEMENTARY INFORMATION: The
Oak Campus due to a disability, please Pediatric Disease Priority Review
purpose of this public workshop is to
contact Shari Solomon at Voucher Program and for a link to the
provide an opportunity for stakeholders,
Shari.Solomon@fda.hhs.gov at least 7 full text of section 529 of the FD&C Act,
including scientists from government,
days in advance. go to http://www.fda.gov/ForIndustry/
academia, and industry, patient
advocacy groups, clinicians, Dated: October 11, 2016. DevelopingProductsforRareDiseases
pharmacists, and the general public to Leslie Kux, Conditions/RarePediatricDiseasePriority
discuss marketed generic drugs. Generic VoucherProgram/default.htm. For
Associate Commissioner for Policy.
drugs account for 88 percent of further information about EXONDYS 51
[FR Doc. 2016–25004 Filed 10–14–16; 8:45 am]
prescriptions in the United States. In (eteplirsen) go to the ‘‘Drugs@FDA’’ Web
BILLING CODE 4164–01–P
light of the significant contributions of site at http://www.accessdata.fda.gov/
generic drugs to public health, it is scripts/cder/drugsatfda/index.cfm.
important that tools are developed to DEPARTMENT OF HEALTH AND Dated: October 6, 2016.
monitor marketed generic drugs to HUMAN SERVICES Leslie Kux,
ensure that they have the same safety Associate Commissioner for Policy.
and effectiveness as their reference Food and Drug Administration [FR Doc. 2016–24947 Filed 10–14–16; 8:45 am]
listed drug. Specifically, this workshop [Docket No. FDA–2014–N–0229] BILLING CODE 4164–01–P
will include presentations on: (1)
Current generic drug surveillance Issuance of Priority Review Voucher;
practices at FDA and in industry, (2) Rare Pediatric Disease Product DEPARTMENT OF HEALTH AND
public perception of generic drug HUMAN SERVICES
quality and effectiveness, (3) generic AGENCY: Food and Drug Administration,
drug substitution studies in patients, HHS. Food and Drug Administration
and (4) development of methods and ACTION: Notice.
[Docket No. FDA–2014–D–0901]
tools to conduct postmarket surveillance
SUMMARY: The Food and Drug
of generic drugs. The workshop will Abbreviated New Drug Application
Administration (FDA) is announcing the
include four panel sessions for Submissions—Prior Approval
issuance of a priority review voucher to
interaction and discussion among the Supplements Under Generic Drug User
the sponsor of a rare pediatric disease
speakers and attendees. Fee Amendments; Guidance for
product application. The Federal Food,
Agenda: The agenda is available at Industry; Availability
Drug, and Cosmetic Act (the FD&C Act),
http://www.fda.gov/scienceresearch/
as amended by the Food and Drug AGENCY: Food and Drug Administration,
specialtopics/regulatoryscience/
Administration Safety and Innovation HHS.
ucm521545.htm.
Registration: There is no registration Act (FDASIA), authorizes FDA to award
priority review vouchers to sponsors of ACTION: Notice of availability.
fee to attend this public workshop. Seats
are limited and registration will be on rare pediatric disease product SUMMARY: The Food and Drug
a first-come, first-served basis. Advance applications that meet certain criteria. Administration (FDA or Agency) is
registration is required and is online FDA has determined that EXONDYS 51 announcing the availability of a
only at http://www.fda.gov/ (eteplirsen), manufactured by Sarepta guidance for industry entitled ‘‘ANDA
scienceresearch/specialtopics/ Therapeutics, meets the criteria for a Submissions—Prior Approval
regulatoryscience/ucm521545.htm. priority review voucher. Supplements Under GDUFA.’’ The
There will be no day-of, onsite FOR FURTHER INFORMATION CONTACT: Generic Drug User Fee Amendments of
registration. Larry Bauer, Rare Diseases Program, 2012 (GDUFA) enables FDA to assess
Streaming Webcast of the Public Center for Drug Evaluation and user fees to fund critical and measurable
Workshop: This public workshop will Research, Food and Drug improvements to FDA’s generic drugs
also be Webcast. There is no registration Administration, 10903 New Hampshire program. This guidance is intended to
jstallworth on DSK7TPTVN1PROD with NOTICES

fee for access to the workshop via the Ave., Silver Spring, MD 20993–0002, assist applicants preparing to submit to
Webcast, but registration is still 301–796–4842, FAX: 301–796–9858, FDA prior approval supplements (PASs)
required. Information regarding email: larry.bauer@fda.hhs.gov. and amendments to PASs for
registration and access to the Webcast SUPPLEMENTARY INFORMATION: FDA is abbreviated new drug applications
link is available at http://www.fda.gov/ announcing the issuance of a priority (ANDAs). It describes FDA’s
scienceresearch/specialtopics/ review voucher to the sponsor of a rare performance metric goals for PASs and
regulatoryscience/ucm521545.htm. If pediatric disease product application. clarifies how FDA will handle a PAS

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Document Created: 2016-10-15 01:51:42
Document Modified: 2016-10-15 01:51:42

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of public workshop.
Dates		The public workshop will be held on November 18, 2016, from 8:30 a.m. to 4:30 p.m.
Contact		Audrey Thomas, Office of Regulatory Science and Innovation, Office of the Chief Scientist, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4220, Silver Spring, MD 20993-0002, 301-796-3520, [email protected]
FR Citation		81 FR 71510

81 FR 71510 - Substitutability of Generic Drugs: Perceptions and Reality; Public Workshop

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 200 (October 17, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration