Nonprescription Drugs Advisory Committee Meeting

1
Nonprescription Drugs Advisory Committee Meeting

• Charles J. Ganley, M.D.
• Division of OTC Drug Products
• September 20, 2002

2
Outline

• Marketing of OTC Drug Products
• Safety and Effectiveness of Internal Analgesic
  Products
• Topic for todays discussion Gastrointestinal
  bleeding and renal toxicity associated with use
  of aspirin and OTC nonsteroidal antiinflammatory
  drug products

3
OTC Marketing of Drug Products

• OTC drugs can be marketed under two different
  regulatory paths
• OTC Drug Review
• Drug Monographs categorized by indications,
  pharmacological effect and body system affected
• New Drug Application (NDA)

4
OTC Drug Review

• Data collection for ingredients
• Drug Review Panel
• Publication of a panel report
• Tentative Final Monograph (Proposed Rule)
• Final monograph
• generally recognized as safe and effective (GRAS)
  
• establishes the conditions of use
• ingredient, indication, dose, test methodologies,
  warnings, directions for use

5
OTC Internal Analgesics

• Monograph
• Acetaminophen
• Aspirin
• Non-Aspirin Salicylates
• Adjuvant (caffeine)

• New Drug Applications
• Ibuprofen
• Ketoprofen
• Naproxen sodium
• Acetaminophen
• Extended release
• Suppository

6
Risk/Benefit of OTC Internal Analgesic Drug
Products

• Consumers can self diagnose and treat
  intermittent minor aches and pain without the
  need for a healthcare provider.
• Serious adverse events are rare. The majority of
  consumers use these products safely.
• The benefit of these therapies outweigh the risks
  associated with their use.

7
OTC Internal Analgesics

• The availability of these ingredients in OTC drug
  products is not an issue.
• The Agency believes that these products should
  remain available as over the counter drug
  products.

8
GI Bleeding and Renal Toxicity Associated with
NSAID and ASA

• For NSAIDs and ASA
• Risk for toxicity is recognized at prescription
  and professional use doses
• Assessment of the risk at OTC doses

9
Aspirin Professional Use

• Aspirin is used chronically for cardiovascular
  and rheumatologic indications
• Professional Use Labeling
• risk of GI bleeding
• risk of renal toxicity
• Warnings are not provided to the consumer on the
  OTC labeling for aspirin

10
Ibuprofen Proposed Rule

• Published August 21, 2002
• Proposes warnings
• This is a proposed rule and is non-binding.
• Final rule will be influenced by the
• Comments and data provided in response to the
  rulemaking
• Recommendations from the advisory committee

11
Risk Management

• What are the risks for GI and renal toxicity
  associated with OTC doses of NSAIDs and aspirin?
• Should there be labeling or other risk management
  measures to decrease risk or morbidity?
• Identify whether additional research is needed.