Bayer Corporation Consumer Care Division September 19, 2002 Allen H' Heller, MD Vice President, Glob

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Bayer CorporationConsumer Care
DivisionSeptember 19, 2002Allen H. Heller,
MDVice President, Global Research Development
Consumer Care
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Bayer OTC Analgesic Products

• Acetaminophen Containing - Multi-symptom
  Combinations
• Alka-Seltzer ? Plus -- Cough/Cold/Allergy
• Midol? -- Menstrual
• Acetaminophen Containing - Analgesic Combination
• Vanquish?
• Non-Acetaminophen Containing - General Analgesics
• Bayer? Aspirin
• Aleve? (Naproxen Sodium)
• Midol? Cramp (Ibuprofen)

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Combination Products

• Consumer benefit
• - multi-symptom relief
• - convenience
• Not associated with significant adverse reports
  (including liver failure)
• Voluntarily labeled

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Bayer Position

• Acknowledges importance of clear, concise,
  ingredient specific labeling
• Supports (and has adopted) CHPA proposed labeling
  regarding risk of simultaneous APAP use
• Submits that additional regulatory intervention
  beyond labeling on combination products is not
  warranted

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Combination Product Safety

• FDA spontaneous report database suggests low
  hepatic risk potential of combination products
• Bayer has received no reports of adverse hepatic
  (serious or non-serious) outcomes and no deaths
  with any of its acetaminophen containing products
• Adverse Event Reports 1995 - March 2001
• Total Reports 1,758
• Serious 1.0

Where product category was specified (227
cases), 53.7 involved a prescription narcotic
analgesic combination product and 33.5 involved
a single ingredient acetaminophen product, while
less than 12 involved an OTC combination
product.
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Combination Product Safety (Continued)

• Combination product use pattern (short term,
  other ingredients, packaging) enhances benefit
  risk relationship
• Enhanced warning (CHPA) will further educate
  consumers regarding the potential risk of
  simultaneous use of multiple products containing
  APAP

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Analgesic Labeling

• Labeling must be based on substantial evidence
• Individual ingredients should be regulated based
  on their unique pharmacology/toxicology
• Overall safety risk is low and does not differ
  appreciably across the ingredients

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Switching Argument

• Estimates presented to this Committee regarding
  excess injury due to potential switching are
  biased and flawed
• Based on data from prescription use that are not
  relevant to OTC use
• Contradicts recent findings that demonstrate
  comparable GI risks across OTC analgesic
  ingredients
• Considers only the hepatic risk of APAP and does
  not consider other potential risk factors
  associated with APAP

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Conclusion

• All OTC analgesic ingredients are safe and
  effective
• Necessity for regulatory action with APAP should
  be independent of other ingredients and based on
  sound scientific principles
• CHPA-proposed labeling on simultaneous use of
  acetaminophen-containing products is appropriate
• Further regulatory interventions for
  APAP-containing combination products are not
  warranted