FDA Perspective on Review of Innovative Systems for Drug Delivery

1
FDA Perspective on Review of Innovative Systems
for Drug Delivery

• Perspective from CDERs Division of Reproductive
  and Urologic Drug Products (DRUDP)

2
Experience and Lessons Learned from Contraceptive
and other Drug /Device Therapeutic Systems

• Dan Shames MD
• Director,
• FDA/CDER/DRUDP

3
Innovative Drug/Device Systems for Contraception

• Norplant I,II, Jadelle (1990, 96, 01)
• six and two rod systems
• systemic levonorgestrel (LNG)
• 5 year efficacy
• 1000 women-years preapproval experience
• interactions mostly with CDER technical experts
  (chemists, clinical pharmacology, toxicology,
  microbiology)

4
Innovative Drug/Device Systems for Contraception

• Lunelle (2000)
• Injectable E P, systemic
• Prefilled syringe or vial both single dose only
• Every month
• 1000 women-years preapproval experience
• interactions mostly with CDER technical experts

5
Innovative Drug/Device Systems for Contraception

• Mirena (2000)
• Intrauterine System
• releases LNG locally
• 5 year efficacy
• 1000 women-year preapproval experience
• interactions with CDRH and CDER technical experts

6
Innovative Drug/Device Systems for Contraception

• Nuvaring (2001)
• intravaginal ring
• EP systemically
• insert for 21 remove for 7 days
• 1000 women-year preapproval experience
• interactions mostly with CDER technical experts

7
Innovative Drug/Device Systems for Contraception

• Ortho-Evra (2001)
• transdermal system
• EP systemic
• apply every 7 days (3 out of 4 weeks)
• 1000 women-year preapproval experience
• interactions mostly with CDER technical experts

8
Lessons Learned by DRUDP

• The Good News (mostly it goes well)
• we can work with device technical experts (from
  CDER and CDRH) in a productive and efficient
  manner to review innovative drug delivery systems
• there were few clinical trial design conflicts
  when sponsor met CDER standards for evidence
• development went well when sponsor knew of CDERs
  evidence requirements a priori

9
Lessons Learned by DRUDP

• The Other News (when it doesnt go well)
• sometimes the systems are really out of the box
• who is in charge CDRH versus CDER (turf ?)
• Culture Clashes
• the pointy headed bureaucrats whose main goal is
  to keep things off the market because they have
  no regard for the entrepreneurial spirit and
  good ole American ingenuity versus
• those people who will approve anything that
  doesnt blow up when they plug it in, regardless
  of consequence to patient safety

10
Lessons Learned by DRUDP

• Culture Clashes (continued)
• the engineers versus the doctors
• reasonable versus substantial evidence
• big Pharma versus small firms

11
Lessons Learned by DRUDP

• Good News Again (the future)
• Office of Combination Products is helping to
  bridge the gap and improve the processes
• improved understanding between CDER, CDRH
  reviewers regarding the processes and regulations
• getting the message out that development plans
  should be worked out early
• most staff at CDER, CDRH enjoy working on
  innovative products and are well motivated to
  assist the sponsors and improve our internal
  processes