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)

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, 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.

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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