Understanding FDA

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Understanding FDA

• Suzanne OShea
• AdvaMed
• 2008 Emerging Growth Companies Conference
• March 11, 2008

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What is a Drug?

• intended for use in the diagnosis, cure,
  mitigation, treatment or prevention of disease in
  man or other animals
• intended to affect the structure or function of
  the body or man or other animals
• Section 201(g) of the Act 21 U.S.C. 321(g)

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What is a Device?

• instrument, apparatus, implement, machine,
  contrivance, implant, in vitro reagent, or other
  similar or related article, including any
  accessory,
• which is

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What is a Device?

• intended for use in the diagnosis of disease or
  other conditions, or in the cure, mitigation,
  treatment or prevention of disease in man or
  other animals, or
• intended to affect the structure or function of
  the body of man or other animals
• AND

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What is a Device?

• which does not achieve its primary intended
  purposes through chemical action within or on the
  body of man
• and
• which is not dependent upon being metabolized for
  the achievement of its primary intended purposes.
• Section 201(h) of the Act 21 U.S.C. 321(h)

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All Devices are Drugs
Drugs
Biologics
Devices
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• In general, when a product meets the
  definition of a device, it is classified as a
  device.

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• Can a product be both a drug
• and a device?

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• This product is intended to be a diluent to
  reconstitute a
• lyophilized drug.
• It is a ____________.

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drug
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• This product is intended to cleanse wounds by
  the physically
• washing away debris.
• It is a _______________.

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device
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• This product is intended to sterilize locally
  available water, e.g. for a battlefield operating
  room or to reconstitute drugs in a natural
  disaster.
• It is a ___________________.

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device with an unregulated article
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What is a Combination Product?
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The milk, eggs, sugar flour theory

• Adverse Event reporting
• GMPs, QSRs
• interstate commerce

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The cake theory

• one marketing application
• (in appropriate cases, FDA may require two
  applications. 21 CFR 3.4(c).)
• one investigational application

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More cake

• Review of a drug under a device application
• only in a combination product

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Barrier Devices
Mouthwash
Bacteria
Decapinol? Oral Rinse, RFD 2004.013, March 3,
2004 http//www.fda.gov/oc/combination/rfd/RFD202
004-013.pdf
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Competitive Binding
DRUG
DRUG
DRUG
DRUG
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• A radical suggestion

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In the meantime

• The regulatory pathway has many twists and turns
• Develop an integrated regulatory strategy,
  including regulatory identity of product, trial
  design, product payment
• Consult with FDA early and often