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Committee Detail

Hide Section - GENERAL INFORMATION

GENERAL INFORMATION

Committee NamePharmaceutical Science and Clinical Pharmacology Advisory CommitteeAgency NameDepartment of Health and Human Services
Fiscal Year2019Committee Number878
Original Establishment Date11/28/1990Committee StatusChartered
Actual Termination Date Committee URLhttp://www.fda.gov/AdvisoryCommittees/Committee...
New Committee This FYNoPresidential Appointments*No
Terminated This FYNoMax Number of Members*17
Current Charter Date1/22/2018Designated Fed Officer Position Title*DFO
Date Of Renewal Charter1/22/2020Designated Federal Officer Prefix
Projected Termination Date Designated Federal Officer First Name*Jay
Exempt From Renewal*NoDesignated Federal Officer Middle NameR.
Specific Termination AuthorityDesignated Federal Officer Last Name*Fajiculay
Establishment Authority*Authorized by LawDesignated Federal Officer SuffixPharm.D.
Specific Establishment Authority*21 U.S.C. 394Designated Federal Officer Phone*(301) 796-9001
Effective Date Of Authority*11/28/1990Designated Federal Officer Fax*(301) 847-8533
Committee Type*ContinuingDesignated Federal Officer Email*jay.fajiculay@fda.hhs.gov
Presidential*No
Committee Function*Scientific Technical Program Advisory Board
Hide Section - RECOMMENDATION/JUSTIFICATIONS

RECOMMENDATION/JUSTIFICATIONS

Agency Recommendation*Continue
Legislation to Terminate RequiredNot Applicable
Legislation StatusNot Applicable
How does cmte accomplish its purpose?*The Committee shall provide advice on scientific, clinical and technical issues related to safety and effectiveness of drug products for use in the treatment of a broad spectrum of human diseases, the quality characteristics which such drugs purport or are represented to have and as required, any other product for which the Food and Drug Administration has regulatory responsibility, and make appropriate recommendations to the Commissioner of Food and Drugs.
How is membership balanced?*Members are selected from academic, research and practice settings and include researchers knowledgeable in the fields of biostatistics, bioavailability, clinical pharmacology, pharmacokinetics, pharmaceutics, industrial pharmacy, statistics, biopharmaceutics, and other related professions. The committee included one technically qualified voting member who is identified with consumer interests. The committee may also include four non-voting members who are identified with industry interests.
How frequent & relevant are cmte mtgs?*The committee met one time during FY-19.

On May 7, 2019, the committee discussed the following topics: (1) approaches to evaluate the effect of renal impairment on drug exposure, and (2) best practice considerations for translating pharmacokinetic (PK) information into dose individualization instructions. Regarding topic 1, many registration trials exclude patients with advanced kidney disease, and product labeling dosing instructions for these patients are commonly derived from our understanding of the change in the PK in individuals with varying degrees of renal function. The most common current approach to determine dosing instructions for patients with varying degrees of renal function begins with a stand-alone renal impairment study, either full design or reduced design. In addition to stand-alone renal impairment studies, drug development programs often use the findings from population PK (POPPK) analyses, which leverage the PK information across all the studies available in a drug development program. An alternative approach to consider is for drug development programs to predict the impact of renal impairment on the PK of the drug, either based on the understanding of the PK of a new molecular entity or using physiologic based PK (PBPK) models, without a stand-alone renal impairment study. Patients with impaired renal function can then be included in later stage clinical trials, with prospective dose adjustment incorporated if deemed necessary based the predictions. The dosing should be confirmed based on analysis of PK samples from the late stage trials (sparse PK, POPPK analysis). Regarding topic 2, dose individualization is typically achieved by applying the concept of ‘exposure-matching’ under the assumption that such a maneuver will result in a benefit-risk similar to that observed in the registration trials. The committee discussed the application of ‘exposure matching,’ including the necessary assumptions and any limitations. The committee supported the inclusion of patients with renal impairment in clinical trials to inform dosing for this large population.The committee also discussed overarching strategies that could improve the outcomes of studies that include patients with renal impairment, such as prespecifying adverse events that are associated with renal impairment to improve data analysis, or by advocating for the use of eGFR as the measure of renal function. Agency Action: The Agency is still reviewing all recommendations that were made at the meeting.

It is expected that the committee will meeting twice during FY-20.
Why advice can't be obtained elsewhere?*Members of the committee are drawn from academia, research, and/or clinical practice. Their advice and input lends credibility to regulatory decisions made and helps those decisions stand up to intense public scrutiny. The alternate means of obtaining this advice would be to hire large numbers of scientists on a full time basis at great expense to the government.
Why close or partially close meetings?The committee held no closed meetings during FY-19.
Recommendation RemarksThis committee was not required to do any reporting for FY-19.
Hide Section - PERFORMANCE MEASURES

PERFORMANCE MEASURES

Outcome Improvement To Health Or Safety*YesAction Reorganize Priorities*Yes
Outcome Trust In GovernmentYesAction Reallocate ResourcesNo
Outcome Major Policy ChangesYesAction Issued New RegulationsYes
Outcome Advance In Scientific ResearchYesAction Proposed LegislationNo
Outcome Effective Grant MakingNoAction Approved Grants Or Other PaymentsNo
Outcome Improved Service DeliveryNoAction OtherYes
Outcome Increased Customer SatisfactionYesAction CommentFDA approves or chooses not to approve an investigational new medical product.
Outcome Implement Laws/Reg RequirementsYesGrants Review*No
Outcome OtherNoNumber Of Grants Reviewed0
Outcome CommentN/ANumber Of Grants Recommended0
Cost Savings*Unable to DetermineDollar Value Of Grants Recommended$0.00
Cost Savings CommentThe utilization of the Pharmaceutical Science and Clinical Pharmacology Advisory Committee enabled the Agency to obtain required and frequently scarce services from medical and scientific experts not otherwise available to the Agency; and to obtain the services from these experts only on an as needed basis rather than on a full time basis. The service of the Committee resulted in advice for the improvement of the public health, for which it is difficult to assign a financial value.Grants Review CommentN/A
Number Of Recommendations*145Access Contact Designated Fed. Officer*Yes
Number Of Recommendations CommentThe committee made 145 recommendations from FY-03 through the first half of FY-19. See question 20a of the annual report for specific accomplishments.Access Agency WebsiteYes
% of Recs Fully Implemented*80.00%Access Committee WebsiteYes
% of Recs Fully Implemented CommentThe function of an advisory committee is purely advisory in nature. Although the FDA most often accepts the recommendations from its committees, the advice is purely advisory in nature, and therefore, the Agency has the option of not implementing the advice.Access GSA FACA WebsiteYes
% of Recs Partially Implemented*10.00%Access PublicationsYes
% of Recs Partially Implemented CommentThe function of an advisory committee is purely advisory in nature. Although the FDA most often accepts the recommendations from its committees, the advice is purely advisory in nature, and therefore, the Agency has the option of not implementing the advice.Access OtherNo
Agency Feedback*YesAccess CommentN/A
Agency Feedback CommentIt usually does. Product approval issues are first released to the sponsor. When appropriate, information is made available to the public. Actions related to guidance documents or other general matters issues are available publicly when implemented.Narrative Description*FDA’s strategic priorities in responding to the public health challenges of the 21st century are to advance regulatory science and innovation; strengthen the safety and integrity of the global supply chain; strengthen compliance and enforcement activities to support public health; expand efforts to meet the needs of special populations; advance medical countermeasures and emergency preparedness; advance food safety and nutrition; promote public health by advancing the safety and effectiveness of medical products; establish an effective tobacco regulation, prevention, and control program; and manage for organizational excellence and accountability. The Pharmaceutical Science and Clinical Pharmacology Advisory Committee supports FDA's strategic priorities by reviewing and evaluating data on scientific and technical issues concerning the safety, and effectiveness of human generic drug products for use in the treatment of a broad spectrum of human diseases, and as required, any other product for which the Food and Drug Administration has regulatory responsibility, and make appropriate recommendations to the Commissioner of Food and Drugs. The Committee may also review Agency sponsored intramural and extramural biomedical research programs in support of FDA's generic drug regulatory responsibilities. This supports the development of safe and effective new medical technologies, and advances the status of the Agency as a science-based and science-led regulatory agency, providing global leadership in the protection of public health.
Hide Section - COSTS

COSTS

Payments to Non-Federal Members* Est Payments to Non-Fed Members Next FY* 
Payments to Federal Members* Est. Payments to Fed Members Next FY* 
Payments to Federal Staff* Estimated Payments to Federal Staff* 
Payments to Consultants* Est. Payments to Consultants Next FY* 
Travel Reimb. For Non-Federal Members* Est Travel Reimb Non-Fed Members nextFY* 
Travel Reimb. For Federal Members* Est Travel Reimb For Fed Members* 
Travel Reimb. For Federal Staff* Est. Travel Reimb to Fed Staff Next FY* 
Travel Reimb. For Consultants* Est Travel Reimb to Consultants Next FY* 
Other Costs Est. Other Costs Next FY* 
Total Costs$0.00Est. Total Next FY*$0.00
Federal Staff Support (FTE)* Est. Fed Staff Support Next FY* 
Hide Section - Custom Links

Custom Links

     Committee Level Reports               
Hide Section - MEMBERS,MEETINGS AND ADVISORY REPORTS

MEMBERS,MEETINGS AND ADVISORY REPORTS

To View all the members, meetings and advisory reports for this committee please click here
Hide Section - CHARTERS AND RELATED DOCS

CHARTERS AND RELATED DOCS

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Hide Section - DATA FROM PREVIOUS YEARS

DATA FROM PREVIOUS YEARS

Committee

Data from Previous Years

 
ActionCommittee System IDCommittee NameFiscal Year
 COM-002078Pharmaceutical Science and Clinical Pharmacology Advisory Committee2017
 COM-002268Pharmaceutical Science and Clinical Pharmacology Advisory Committee2016
 COM-003783Advisory Committee for Pharmaceutical Science and Clinical Pharmacology2015
 COM-004348Advisory Committee for Pharmaceutical Science and Clinical Pharmacology2014
 COM-006261Advisory Committee for Pharmaceutical Science and Clinical Pharmacology2013
 COM-006860Advisory Committee for Pharmaceutical Science and Clinical Pharmacology2012
 COM-008272Advisory Committee for Pharmaceutical Science and Clinical Pharmacology2011
 COM-009086Advisory Committee for Pharmaceutical Science and Clinical Pharmacology2010
 COM-010059Advisory Committee for Pharmaceutical Science and Clinical Pharmacology2009
 COM-010984Advisory Committee for Pharmaceutical Science and Clinical Pharmacology2008
 COM-012167Advisory Committee for Pharmaceutical Science and Clinical Pharmacology2007
 COM-012617Advisory Committee for Pharmaceutical Science2006
 COM-013916Advisory Committee for Pharmaceutical Science2005
 COM-014526Advisory Committee for Pharmaceutical Science2004
 COM-015956Advisory Committee for Pharmaceutical Science2003
 COM-016551Advisory Committee for Pharmaceutical Science2002
 COM-017582Advisory Committee for Pharmaceutical Science2001
 COM-018510Advisory Committee for Pharmaceutical Science2000
 COM-019736Advisory Committee for Pharmaceutical Science1999
 COM-020428Advisory Committee for Pharmaceutical Science1998
 COM-021533Advisory Committee for Pharmaceutical Science1997
 COM-034615Pharmaceutical Science and Clinical Pharmacology Advisory Committee2018