[Federal Register Volume 80, Number 248 (Monday, December 28, 2015)]
[Notices]
[Pages 80776-80777]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-32476]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]


Externally-Led Patient-Focused Drug Development Meetings

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the opportunity for externally-led patient-focused drug development 
meetings. The Patient-Focused Drug Development (PFDD) initiative is 
part of FDA's commitments under the fifth authorization of the 
Prescription Drug User Fee Act (PDUFA V). The PFDD initiative aims to 
more systematically obtain the patient perspective on specific diseases 
and their treatments. FDA recognizes that there are many more disease 
areas than can be addressed in the planned FDA meetings under PDUFA V. 
To help expand the benefits of FDA's PFDD initiative, FDA welcomes 
patient organizations to identify and organize patient-focused 
collaborations to generate public input on other disease areas, using 
the process established through Patient-Focused Drug Development as a 
model.

ADDRESSES: FDA recommends that patient organizations who are interested 
in conducting an externally-led PFDD meeting initially engage with FDA 
by submitting a letter of intent (LOI) to [email protected]. 
Submission details are outlined on FDA's Web site: http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm453856.htm.

FOR FURTHER INFORMATION CONTACT: Pujita Vaidya, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 1144, Silver Spring, MD 20993-0002, 301-
796-0684.

SUPPLEMENTARY INFORMATION: As part of its commitments under the 
Prescription Drug User Fee Act reauthorization of 2012, FDA has taken 
several steps to inform the benefit-risk assessments that inform CDER's 
regulatory decisions concerning new drugs. Among these efforts is the 
PFDD initiative that aims to more systematically obtain the patient 
perspective on specific diseases and their treatments. FDA has 
committed to obtaining the patient perspective on at least 20 disease 
areas during the course of PDUFA V. PFDD meetings give FDA an important 
opportunity to hear directly from patients, patient advocates, and 
caretakers about the symptoms that matter most to them; the impact the 
disease has on patients' daily lives; and patients' experiences with 
currently available treatments. The patient perspective is critical in 
helping FDA understand the context in which regulatory decisions are 
made for new drugs. This patient input can inform FDA's decisions and 
oversight both during drug development and during our review of a 
marketing application.
    The Agency recognizes that there has been growing external interest 
in expanding efforts to gather patient input in support of drug 
development and evaluation. To help expand the benefits of FDA's PFDD 
initiative, FDA welcomes patient organizations to identify and organize 
patient-focused collaborations to generate public input on other 
disease areas, using the process established through Patient-Focused 
Drug Development as a model. An externally-led PFDD meeting and any 
resulting products (e.g., surveys or reports) will not be considered 
FDA-sponsored or FDA-endorsed, and FDA does not guarantee specific 
involvement in such meetings. However, FDA will be

[[Page 80777]]

open to participating in a well-designed and well-conducted meeting on 
a case-by-case basis. Given the expanse of diseases affecting the U.S. 
patient population and the effort required to conduct a successful PFDD 
meeting, externally-led PFDD meetings should target disease areas where 
there is an identified need for patient input on topics related to drug 
development. FDA will determine its level of participation in these 
meetings on an individual basis, taking into account a number of 
factors, including any identified need for a better understanding of 
patient perspective, recent interactions with patient stakeholders, 
proposed meeting details, and FDA staff capacity. More information 
regarding considerations to take into account when deciding to plan an 
externally-led PFDD meeting can be found on this Web site: http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm453856.htm.
    FDA recommends that patient organizations who are interested in 
conducting an externally-led PFDD meeting submit an LOI that 
communicates (1) the value of the proposed meeting in the context of 
drug development for a particular disease area, and (2) important 
details regarding the meeting plan. Guidelines for developing a letter 
of intent are provided here: http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM453857.pdf. Please submit the 
letter of intent to [email protected]. FDA's CDER Office of 
Strategic Programs will receive and review the letter.

    Dated: December 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-32476 Filed 12-24-15; 8:45 am]
 BILLING CODE 4164-01-P