[Federal Register Volume 79, Number 213 (Tuesday, November 4, 2014)]
[Notices]
[Pages 65410-65411]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-26145]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1698]


Food and Drug Administration Activities for Patient Participation 
in Medical Product Discussions; Establishment of a Public Docket

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; Establishment of docket; Request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
establishment of a public docket for comments on FDA activities 
performed under the Food and Drug Administration Safety and Innovation 
Act (FDASIA), Patient Participation in Medical Product Discussions. 
This notice announces FDA's intent to gather input from stakeholders on 
strategies to obtain the views of patients during the medical product 
development process and ways to consider patients' perspectives during 
regulatory discussions. This notice provides background on ongoing 
patient engagement activities, so that stakeholders can consider both 
current and new activities that involve patient participation and 
perspectives during medical product regulatory discussions.

DATES: Although FDA welcomes comments at any time, to help FDA address 
issues related to Patient Participation in Medical Products Discussions 
in a timely fashion, comments should be submitted by December 4, 2014.

ADDRESSES: Submit electronic comments to http://www.regulations.gov. 
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Andrea Furia-Helms, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5319, Silver 
Spring, MD 20993-0002, <a href="/cdn-cgi/l/email-protection#40012e243225216e0635322921002624216e2828336e272f36"><span class="__cf_email__" data-cfemail="0a4b646e786f6b244c7f78636b4a6c6e6b24626279246d657c">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Background

    On July 9, 2012, the President signed into law FDASIA (Pub. L. 112-
144). FDASIA expands the FDA's authorities and strengthens the Agency's 
ability to safeguard and advance public health in several areas 
including increasing stakeholder involvement in FDA regulatory 
processes. Specifically, section 1137 of FDASIA directs the Secretary 
of HHS to ``develop and implement strategies to solicit the views of 
patients during the medical product development process and consider 
the perspectives of patients during regulatory discussions, including 
by--(1) fostering participation of a patient representative who may 
serve as a special government employee in

[[Page 65411]]

appropriate agency meetings with medical product sponsors and 
investigators; and (2) exploring means to provide for identification of 
patient representatives who do not have any, or have minimal, financial 
interests in the medical products industry.''
    FDA has formed an Agency-wide working group to explore approaches 
and procedures as well as to align strategies across the Agency for 
patient participation in accordance with the statute. Involvement of 
the patient community brings the unique perspective of patients, family 
members, caregivers, and patient advocates to the decision-making 
processes of the FDA, and FDA is currently using a variety of tools to 
help ensure that the patient community is involved in medical product 
discussions to enhance benefit-risk assessment. FDA assesses the 
benefit-risk of new drugs and certain devices on a case-by-case basis. 
In this assessment, FDA may consider, among other things, the degree of 
unmet medical need and the severity and morbidity of the condition or 
disease the drug or device is intended to treat or diagnose. This 
approach has been critical to increasing patient access to new 
treatments for cancer, other serious diseases, and rare diseases, where 
existing therapies have been few and limited in their effectiveness.
    Currently, patient representatives can serve as Special Government 
Employees (SGEs) in order to participate as a member of an FDA's 
federal advisory committee meeting about medical products undergoing 
the FDA review process for marketing approval and other regulatory 
issues. Patient representatives serve as committee members on advisory 
committees managed by the Office of the Commissioner, Center for Drug 
Evaluation and Research, Center for Biologics Evaluation and Research, 
and Center for Devices and Radiological Health. SGE patient 
representatives may also serve on special assignments to provide 
feedback and perspective on product reviews in progress. These SGE 
activities are in addition to the many other activities in which FDA 
obtains patient perspectives, such as open public hearings on specific 
diseases or drug development issues, and as speakers at FDA-sponsored 
conferences and workshops.
    FDASIA includes the reauthorization of the Prescription Drug User 
Fee Act (PDUFA) that provides FDA with the necessary resources to 
maintain a predictable and efficient review process for human drug and 
biological products. This is the fifth authorization of PDUFA 
(otherwise known as ``PDUFA V''), which was, as directed by Congress, 
developed in consultation with drug industry representatives, patient 
and consumer advocates, health care professionals, and other public 
stakeholders. Under PDUFA V, FDA intends to conduct at least 20 public 
meetings that aim to more systematically gather patients' perspectives 
on their conditions and available therapies to treat those conditions 
(Patient Focused Drug Development). PDUFA V also includes an initiative 
to enhance FDA's review of patient-reported outcome study endpoints and 
endpoint assessment tools.
    FDASIA also includes the reauthorization of the Medical Device User 
Fee Act (MDUFA) that provides FDA the necessary resources to increase 
the efficiency of regulatory processes in order to reduce the time it 
takes to bring safe and effective medical devices to the U.S. market. 
This third authorization of MDUFA (otherwise known as ``MDUFA III''), 
was a result of more than a year of public input, negotiations with 
industry representatives, and discussions with patient and consumer 
stakeholders. Under MDUFA III, FDA has established the Patient 
Preference Initiative to provide the information, guidance, and 
framework necessary to incorporate patient preferences on the benefit-
risk tradeoffs of medical devices into the full spectrum of medical 
device regulatory processes and to inform medical device innovation by 
the larger medical device community. In the process, the initiative 
aims to advance the science of measuring medical device preferences of 
patients, caregivers, and providers. Once the Patient Preference 
Initiative helps to define or refine the methods to measure patient 
preferences, FDA intends to incorporate patient views into the total 
product life cycle of medical devices.
    FDA is opening a docket for 30 days to provide an opportunity for 
interested stakeholders to submit comments on ``strategies to solicit 
the views of patients during the medical product development process 
and consider the perspectives of patients during regulatory 
discussions'' under section 1137 of FDASIA. FDA is interested in 
comments on both current and new activities that would involve patient 
participation in regulatory discussions, as well as comments on ways to 
assess patient participation activities.

II. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: October 29, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-26145 Filed 11-3-14; 8:45 am]
BILLING CODE 4164-01-P


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