Presidents Emergency Plan for AIDS Relief and FDA

1
Presidents Emergency Plan for AIDS Relief
and FDA

• Murray M. Lumpkin, M.D.
• Acting Deputy Commissioner
• US Food and Drug Administration
• US Department of Health and Human Services
• PACHA
• 07 February 2005

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Quality ART

• Host of essential activities and services
• Procuring quality antiretroviral drugs (ARV) and
  other medicinal therapies
• when the world market is composed of
  counterfeits, poor quality, unknown quality, and
  good quality drugs

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Challenges - ARV drugs

• How to assure that ARV and other medicines
  purchased under PEPFAR are QUALITY products?
• Those receiving get greatest benefit from therapy
• Risks of developing resistance are limited as
  much as possible
• How to assure that the programs gets the best
  value for dollar in its drug purchasing efforts
  in order to help treat the largest number of
  patients possible?
• How do we address the issue of asking governments
  to give their people product that we would not
  give our own people?

4
FDA Expedited Marketing Application Review
Process

• In May 2004, in direct support of PEPFAR,
  Department of Health and Human Services (DHHS)
  then Secretary Tommy Thompson announced that FDA
  would implement a new, expedited review process
  for certain drugs to ensure that the US could
  provide safe and effective QUALITY drugs under
  the PEPFAR program

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Components of this Process

• No change in FDA standards efficacy, safety and
  manufacturing quality (including inspections
  GCPs, GLPs, and GMPs
• Open to all manufacturers
• Use of tentative approvals if patents block
  marketing in the USA
• No repetition of clinical efficacy trials for
  combinations when using 21 single entity products
  approved in US
• Faster review and decision by FDA
• Intensive interactions with potential
  manufacturers prior to submission of marketing
  application

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FDA Guidance

• FDA published guidance for the Pharmaceutical
  Industry encouraging manufacturers to submit
  marketing applications for fixed dose combination
  (FDC) and co-packaged versions of previously
  approved single entity anti-retroviral therapies

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FDA Guidance

• Posted on www. fda. gov on May 17, 2004
• Outlines scenarios for review of different FDC
  and co-packaged products
• Generic versions of already authorized products
• New products
• Describes components of a high-quality marketing
  application

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Pre-Application Activities

• Due to the unprecedented nature of the PEPFAR
  initiative, reviewers will work intensively with
  potential manufactures and help work through the
  complex nature of scientific and regulatory
  questions encountered especially, if the
  prospective manufacturer has little or no
  experience with the FDA

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Application Activities

• FDA conducts its traditional drug product review
  activities for both new products and generic
  forms of existing drug products to ensure product
  safety, effectiveness, and manufacturing quality
• FDA has committed to expedite the review of these
  marketing applications generally 6 8 weeks
  after a complete marketing applications is
  submitted

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Application Activities

• Generally, a priority review designation provides
  for the review of a new drug application in 6
  months or less
• The statutory review time for a generic drug
  marketing application is 180 days
• Generic and new drug (new combinations of already
  approved single entity products) applications
  received under PEPFAR would be reviewed within
  even shorter time frames (approximately 8 weeks)

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Inspections

• Because many manufacturers will have little or no
  experience with FDA, FDA will not have existing
  information about most clinical laboratories,
  clinical trial sites, and manufacturing sites
• Therefore, FDA will conduct pre-approval
  inspections of laboratories, cGCP and cGMP
  inspections to ensure the integrity of the data
  in the marketing applications and the drug
  product quality during manufacturing

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Tentative Approval

• For companies making products where another firm
  owns the US patent rights, FDA could issue a
  tentative approval when it finds the product
  meets the FDAs normal safety, efficacy, and
  manufacturing quality standards
• Except for the patent blocking, the product could
  be marketed in the US
• Will assure all products purchased under the
  PEPFAR program are products that we would give to
  our own people

13
Outreach Activities

• FDA has developed comprehensive outreach programs
  for potential manufacturers and national drug
  regulatory authorities that seek to participate
  in PEPFAR. This includes
• Train-the-trainer sessions
• Training for general marketing application and
  approval process information
• Assessment of current good manufacturing
  practices and current good clinical practices
• Post-market adverse event reporting and analysis

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Update

• We do have applications in house under review
• Some companies have made this fact public
• Until approval of a product, FDA is required by
  law to keep this information confidential
• Additional companies have approached us

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Update

• Approvals
• December Barr (US)
• Didanosine delayed-release capsules
• Tentative Approvals
• January Aspen (South Africa)
• Lamivudine 150 mg / zidovudine 300 mg FDC
  co-packaged with nevirapine 200 mg
• 2 tablets each taken BID (first 14 days the
  nevirapine is QD)

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Update

• Large symposium here in US for Drug Regulatory
  Authorities from all 15 PEPFAR countries planned
  for April

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Thank You

• Questions?
• Comments?