FDAs Division of Gastroenterology Products

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FDAs Division of Gastroenterology Products

• Donna Griebel, MD
• Director

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DGPs Place in FDA Drug Review

• Organizational Position
• Center for Drug Evaluation and Research
• Office of New Drugs
• Office of Drug Evaluation III
• Division of Gastroenterology Products
• Product Review
• Small molecules and biological
• Indications
• Gastrointestinal diseases and conditions
• Including GI conditions caused by other
  therapies, eg. nausea and vomiting from
  chemotherapy or anesthesia, constipation due to
  opioids, postoperative ileus
• Inborn Errors of Metabolism
• Hyperalimentation, parenterals
• Consultative role - requests from within CDER and
  across Centers

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DGP Professionals

• Project Managers
• Two Teams
• 16
• Medical Reviewers
• Four Teams
• 22
• Pharmacology and Toxicology Reviewers
• 7
• Support Staff
• 2
• Matrix Staff Chemistry, Biostatistics, Clinical
  Pharmacology and Biopharmaceutics

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Where Weve Been Submissions Received
Gastroenterology / Inborn Errors of Metabolism
Original NDAs/BLAs and Efficacy Supplements
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Where Were Going

• Meeting the challenges of evolving drug
  development, review and regulatory initiatives
• New Division Members
• Division doubled in size over last 7 months
• GRMP pilot
• SEALD
• Pediatric Initiatives
• Communication
• Emerging drug safety issues Early Communication
  About an Ongoing Safety Review

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Newest Initiatives

• Food and Drug Amendments Act (FDAAA)
• Gives FDA new resources for medical product
  safety and new regulatory tools and authorities
  to ensure safe and appropriate use of drugs
• Implementation of Title IX of FDAAA
• New authority
• To require postmarketing studies and clinical
  trials
• To require sponsors to make safety related
  labeling changes
• To require sponsors to develop and comply with
  risk evaluation and mitigation strategies (REMS)
• Timelines for each component for both FDA and
  sponsor
• Tracking
• Ongoing evaluation of effectiveness of the REMS
• New team within Division devoted to safety
  issues
• New Deputy Director for Safety
• Safety Regulatory Project Manager

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Safety First/Safe Use

• CDER is taking steps to provide a focus,
  intensity of tracking, deadlines and
  accountability for postmarketing safety
  activities that equals our focus and performance
  on premarket safety, efficacy and quality
  review.
• Janet Woodcock, MD
• Deputy Commissioner for Scientific and Medical
• Programs, Chief Medical Officer, and Acting
  Director of
• FDAs CDER.
• Testimony before House Agriculture, Rural
  Development,
• Food and Drug Administration and Related Agencies
• Appropriations Subcommittees, February 27, 2008

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DGP

• Established demanding workload multiple
  important new initiatives that must be
  implemented staff that is new to drug review
  Challenge
• Fresh team members equals
• Enthusiasm
• Open mindedness to new approaches
• Steep learning curves
• Training responsibilities added to heavy workload
  for the core group
• Success
• Strength of the core
• High caliber professional staff
• Commitment of both the core and new team members
  to achieve the public health goals
• Support of our Office, OND and Center leadership