FDA’s Division of FDA’s Division of Gastroenterology ProductsGastroenterology Products

Donna Griebel, MDDonna Griebel, MDDirectorDirector

DGP’s Place in FDA Drug Review DGP’s Place in FDA Drug Review

Organizational PositionOrganizational Position– Center for Drug Evaluation and ResearchCenter for Drug Evaluation and Research

Office of New DrugsOffice of New Drugs– Office of Drug Evaluation III Office of Drug Evaluation III

Division of Gastroenterology ProductsDivision of Gastroenterology Products

Product ReviewProduct Review– Small molecules and biologicalSmall molecules and biological– IndicationsIndications

Gastrointestinal diseases and conditionsGastrointestinal diseases and conditions– Including GI conditions caused by other therapies, eg. nausea Including GI conditions caused by other therapies, eg. nausea

and vomiting from chemotherapy or anesthesia, constipation and vomiting from chemotherapy or anesthesia, constipation due to opioids, postoperative ileusdue to opioids, postoperative ileus

Inborn Errors of MetabolismInborn Errors of MetabolismHyperalimentation, parenteralsHyperalimentation, parenterals

– Consultative role - requests from within CDER and Consultative role - requests from within CDER and across Centersacross Centers

DGP ProfessionalsDGP Professionals

Project ManagersProject Managers– Two TeamsTwo Teams– 16 16

Medical ReviewersMedical Reviewers– Four TeamsFour Teams– 2222

Pharmacology and Toxicology ReviewersPharmacology and Toxicology Reviewers– 77

Support StaffSupport Staff– 22

Matrix Staff – Chemistry, Biostatistics, Clinical Matrix Staff – Chemistry, Biostatistics, Clinical Pharmacology and BiopharmaceuticsPharmacology and Biopharmaceutics

Where We’ve Been: Where We’ve Been: Submissions Received – Submissions Received –

Gastroenterology / Inborn Errors of MetabolismGastroenterology / Inborn Errors of Metabolism

0

20

40

60

80

100

120

140

FY03 FY04 FY05 FY06 FY07

NDAs/BLAs*Drug SLRsDrug INDsTB INDsSPAsMtg Reqs

*Original NDAs/BLAs and Efficacy Supplements

Where We’re GoingWhere We’re Going

Meeting the challenges of evolving drug Meeting the challenges of evolving drug development, review and regulatory initiativesdevelopment, review and regulatory initiatives– New Division Members – New Division Members –

Division doubled in size over last 7 monthsDivision doubled in size over last 7 months

– GRMP pilot GRMP pilot

– SEALDSEALD– Pediatric InitiativesPediatric Initiatives– CommunicationCommunication

Emerging drug safety issues – Early Communication About Emerging drug safety issues – Early Communication About an Ongoing Safety Reviewan Ongoing Safety Review

Newest Initiatives Newest Initiatives Food and Drug Amendments Act (FDAAA)Food and Drug Amendments Act (FDAAA)– Gives FDA new resources for medical product safety and new Gives FDA new resources for medical product safety and new

regulatory tools and authorities to ensure safe and appropriate use of regulatory tools and authorities to ensure safe and appropriate use of drugsdrugs

Implementation of Title IX of FDAAAImplementation of Title IX of FDAAA– New authority New authority

To require postmarketing studies and clinical trialsTo require postmarketing studies and clinical trialsTo require sponsors to make safety related labeling changesTo require sponsors to make safety related labeling changesTo require sponsors to develop and comply with risk evaluation and To require sponsors to develop and comply with risk evaluation and mitigation strategies (REMS)mitigation strategies (REMS)

– Timelines for each component for both FDA and sponsorTimelines for each component for both FDA and sponsorTrackingTrackingOngoing evaluation of effectiveness of the REMSOngoing evaluation of effectiveness of the REMS

New team within Division devoted to safety issuesNew team within Division devoted to safety issues– New Deputy Director for SafetyNew Deputy Director for Safety– Safety Regulatory Project ManagerSafety Regulatory Project Manager

Safety First/Safe UseSafety First/Safe Use

““CDER is taking steps to provide a focus, CDER is taking steps to provide a focus, intensity of tracking, deadlines and intensity of tracking, deadlines and accountability for postmarketing safety activities accountability for postmarketing safety activities that equals our focus and performance on that equals our focus and performance on premarket safety, efficacy and quality review.”premarket safety, efficacy and quality review.”

Janet Woodcock, MD Janet Woodcock, MD Deputy Commissioner for Scientific and MedicalDeputy Commissioner for Scientific and MedicalPrograms, Chief Medical Officer, and Acting Director ofPrograms, Chief Medical Officer, and Acting Director of FDA’s CDER. FDA’s CDER. Testimony before House Agriculture, Rural Development,Testimony before House Agriculture, Rural Development,Food and Drug Administration and Related AgenciesFood and Drug Administration and Related AgenciesAppropriations Subcommittees, February 27, 2008Appropriations Subcommittees, February 27, 2008

DGPDGPEstablished demanding workload + multiple important Established demanding workload + multiple important new initiatives that must be implemented + staff that is new initiatives that must be implemented + staff that is new to drug review = Challengenew to drug review = ChallengeFresh team members equalsFresh team members equals– EnthusiasmEnthusiasm– Open mindedness to new approachesOpen mindedness to new approaches– Steep learning curvesSteep learning curves– Training responsibilities added to heavy workload for the core Training responsibilities added to heavy workload for the core

groupgroup

SuccessSuccess– Strength of the coreStrength of the core– High caliber professional staffHigh caliber professional staff– Commitment of both the core and new team members to Commitment of both the core and new team members to

achieve the public health goalsachieve the public health goals– Support of our Office, OND and Center leadershipSupport of our Office, OND and Center leadership