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![Page 1: Regulatory History of Aspirin Cardiovascular and Renal Drugs Advisory Committee Meeting Michelle M. Jackson, Ph.D. Division of Over-The-Counter Drug Products.](https://reader035.fdocuments.in/reader035/viewer/2022070400/56649f115503460f94c23be7/html5/thumbnails/1.jpg)
Regulatory History of AspirinRegulatory History of Aspirin Regulatory History of AspirinRegulatory History of Aspirin
Cardiovascular and Renal Drugs Advisory Committee Meeting
Michelle M. Jackson, Ph.D.Division of Over-The-Counter Drug Products
Cardiovascular and Renal Drugs Advisory Committee Meeting
Michelle M. Jackson, Ph.D.Division of Over-The-Counter Drug Products
Cardiovascular and Renal Drugs AC MeetingCardiovascular and Renal Drugs AC MeetingDecember 8, 2003December 8, 2003
![Page 2: Regulatory History of Aspirin Cardiovascular and Renal Drugs Advisory Committee Meeting Michelle M. Jackson, Ph.D. Division of Over-The-Counter Drug Products.](https://reader035.fdocuments.in/reader035/viewer/2022070400/56649f115503460f94c23be7/html5/thumbnails/2.jpg)
2Cardiovascular and Renal Drugs AC MeetingCardiovascular and Renal Drugs AC MeetingDecember 8, 2003December 8, 2003
ContentContentContentContent
• The OTC Drug Monograph Process
• Regulatory History of Aspirin
• 1989 & 1997 Advisory Committee Discussions
• Professional Labeling for Aspirin
• The OTC Drug Monograph Process
• Regulatory History of Aspirin
• 1989 & 1997 Advisory Committee Discussions
• Professional Labeling for Aspirin
![Page 3: Regulatory History of Aspirin Cardiovascular and Renal Drugs Advisory Committee Meeting Michelle M. Jackson, Ph.D. Division of Over-The-Counter Drug Products.](https://reader035.fdocuments.in/reader035/viewer/2022070400/56649f115503460f94c23be7/html5/thumbnails/3.jpg)
3Cardiovascular and Renal Drugs AC MeetingCardiovascular and Renal Drugs AC MeetingDecember 8, 2003December 8, 2003
OTC Drug Monograph ProcessOTC Drug Monograph ProcessOTC Drug Monograph ProcessOTC Drug Monograph Process
1. Advisory Review PanelsPanels submit reports to FDA
2. Advance Notice of Proposed Rulemaking (ANPR)Public comment period
3. Tentative Final Monograph (TFM)Public comment period
4. Final Monograph (FM)
1. Advisory Review PanelsPanels submit reports to FDA
2. Advance Notice of Proposed Rulemaking (ANPR)Public comment period
3. Tentative Final Monograph (TFM)Public comment period
4. Final Monograph (FM)
![Page 4: Regulatory History of Aspirin Cardiovascular and Renal Drugs Advisory Committee Meeting Michelle M. Jackson, Ph.D. Division of Over-The-Counter Drug Products.](https://reader035.fdocuments.in/reader035/viewer/2022070400/56649f115503460f94c23be7/html5/thumbnails/4.jpg)
4Cardiovascular and Renal Drugs AC MeetingCardiovascular and Renal Drugs AC MeetingDecember 8, 2003December 8, 2003
OTC Drug ReviewOTC Drug ReviewOTC Drug ReviewOTC Drug Review
Citizen Petition (21 CFR 10.30)
• Right of citizens to petition the government
• Used to issue, amend, or revoke a regulation
• Used to take or refrain from taking certain actions
Citizen Petition (21 CFR 10.30)
• Right of citizens to petition the government
• Used to issue, amend, or revoke a regulation
• Used to take or refrain from taking certain actions
![Page 5: Regulatory History of Aspirin Cardiovascular and Renal Drugs Advisory Committee Meeting Michelle M. Jackson, Ph.D. Division of Over-The-Counter Drug Products.](https://reader035.fdocuments.in/reader035/viewer/2022070400/56649f115503460f94c23be7/html5/thumbnails/5.jpg)
5Cardiovascular and Renal Drugs AC MeetingCardiovascular and Renal Drugs AC MeetingDecember 8, 2003December 8, 2003
OTC Drug Review OTC Drug Review (con’t)(con’t)OTC Drug Review OTC Drug Review (con’t)(con’t)
• OTC Drug Labeling – - OTC drug labeling provided for consumers
- Consumers are able to safely self medicate
• Professional Drug Labeling – - OTC drug labeling provided for healthcare
professionals (not for the general public) - Advice of a healthcare professional is needed
for the safe and effective use of the drug product
• OTC Drug Labeling – - OTC drug labeling provided for consumers
- Consumers are able to safely self medicate
• Professional Drug Labeling – - OTC drug labeling provided for healthcare
professionals (not for the general public) - Advice of a healthcare professional is needed
for the safe and effective use of the drug product
![Page 6: Regulatory History of Aspirin Cardiovascular and Renal Drugs Advisory Committee Meeting Michelle M. Jackson, Ph.D. Division of Over-The-Counter Drug Products.](https://reader035.fdocuments.in/reader035/viewer/2022070400/56649f115503460f94c23be7/html5/thumbnails/6.jpg)
6Cardiovascular and Renal Drugs AC MeetingCardiovascular and Renal Drugs AC MeetingDecember 8, 2003December 8, 2003
Regulatory History of AspirinRegulatory History of Aspirin
• July 21, 1972 Review of OTC internal analgesic ingredients
Advisory Review Panel
• July 8, 1977 ANPR - Publication of OTC internal analgesic panel report
Public Comment Period
• November 16, 1988 TFM - Public Comment Period
• May 8, 1989 Comment: Sterling Drug Inc.Claim for aspirin for the prevention of primary heart attack
• October 6, 1989 Advisory Committee Meeting
• July 21, 1972 Review of OTC internal analgesic ingredients
Advisory Review Panel
• July 8, 1977 ANPR - Publication of OTC internal analgesic panel report
Public Comment Period
• November 16, 1988 TFM - Public Comment Period
• May 8, 1989 Comment: Sterling Drug Inc.Claim for aspirin for the prevention of primary heart attack
• October 6, 1989 Advisory Committee Meeting
![Page 7: Regulatory History of Aspirin Cardiovascular and Renal Drugs Advisory Committee Meeting Michelle M. Jackson, Ph.D. Division of Over-The-Counter Drug Products.](https://reader035.fdocuments.in/reader035/viewer/2022070400/56649f115503460f94c23be7/html5/thumbnails/7.jpg)
7Cardiovascular and Renal Drugs AC MeetingCardiovascular and Renal Drugs AC MeetingDecember 8, 2003December 8, 2003
Regulatory History of Aspirin (con’t)Regulatory History of Aspirin (con’t)
• October 15, 1992 Aspirin Foundation (CP9): Claim for treating acute MI
• December 21, 1992 Aspirin Strategy Group (CP10): Claim for treating acute MI
• June 6, 1994 Aspirin Strategy Group (CP12): Claim for anyone at risk for MI and stroke
• June 13, 1996 Amendment to the TFM
• January 23, 1997 Advisory Committee Meeting
• October 23, 1998 Final Monograph: Professional Labeling
• October 15, 1992 Aspirin Foundation (CP9): Claim for treating acute MI
• December 21, 1992 Aspirin Strategy Group (CP10): Claim for treating acute MI
• June 6, 1994 Aspirin Strategy Group (CP12): Claim for anyone at risk for MI and stroke
• June 13, 1996 Amendment to the TFM
• January 23, 1997 Advisory Committee Meeting
• October 23, 1998 Final Monograph: Professional Labeling
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8Cardiovascular and Renal Drugs AC MeetingCardiovascular and Renal Drugs AC MeetingDecember 8, 2003December 8, 2003
ANPR – July 8, 1977ANPR – July 8, 1977 Panel’s Report:Panel’s Report:
ANPR – July 8, 1977ANPR – July 8, 1977 Panel’s Report:Panel’s Report:
• Anti-platelet effects of aspirin
• Increased bleeding time
• Warnings against use in people with GI or bleeding problems, or during pregnancy
• No mention of CV claims
• Anti-platelet effects of aspirin
• Increased bleeding time
• Warnings against use in people with GI or bleeding problems, or during pregnancy
• No mention of CV claims
![Page 9: Regulatory History of Aspirin Cardiovascular and Renal Drugs Advisory Committee Meeting Michelle M. Jackson, Ph.D. Division of Over-The-Counter Drug Products.](https://reader035.fdocuments.in/reader035/viewer/2022070400/56649f115503460f94c23be7/html5/thumbnails/9.jpg)
9Cardiovascular and Renal Drugs AC MeetingCardiovascular and Renal Drugs AC MeetingDecember 8, 2003December 8, 2003
TFM – November 16, 1988TFM – November 16, 1988 TFM – November 16, 1988TFM – November 16, 1988
• Proposed professional labeling for use of aspirin: - reducing the risk of recurrent TIAs or stroke in men
- reducing the risk of death and/or nonfatal MI
- rheumatologic diseases
• Proposed professional labeling for use of aspirin: - reducing the risk of recurrent TIAs or stroke in men
- reducing the risk of death and/or nonfatal MI
- rheumatologic diseases
![Page 10: Regulatory History of Aspirin Cardiovascular and Renal Drugs Advisory Committee Meeting Michelle M. Jackson, Ph.D. Division of Over-The-Counter Drug Products.](https://reader035.fdocuments.in/reader035/viewer/2022070400/56649f115503460f94c23be7/html5/thumbnails/10.jpg)
10Cardiovascular and Renal Drugs AC MeetingCardiovascular and Renal Drugs AC MeetingDecember 8, 2003December 8, 2003
Comments to the TFMComments to the TFMComments to the TFMComments to the TFM
Professional Labeling for Aspirin:
• Use for primary prevention of MI
• Reduce the dose for TIA and stroke from 1,300 mg to 300 mg a day
• Include labeling for both men and women
Professional Labeling for Aspirin:
• Use for primary prevention of MI
• Reduce the dose for TIA and stroke from 1,300 mg to 300 mg a day
• Include labeling for both men and women
![Page 11: Regulatory History of Aspirin Cardiovascular and Renal Drugs Advisory Committee Meeting Michelle M. Jackson, Ph.D. Division of Over-The-Counter Drug Products.](https://reader035.fdocuments.in/reader035/viewer/2022070400/56649f115503460f94c23be7/html5/thumbnails/11.jpg)
11Cardiovascular and Renal Drugs AC MeetingCardiovascular and Renal Drugs AC MeetingDecember 8, 2003December 8, 2003
1989 Advisory Committee Meeting 1989 Advisory Committee Meeting (PHS: Labeling claim for primary prevention of MI)(PHS: Labeling claim for primary prevention of MI)
1989 Advisory Committee Meeting 1989 Advisory Committee Meeting (PHS: Labeling claim for primary prevention of MI)(PHS: Labeling claim for primary prevention of MI)
• No effect on total cardiovascular mortality
• No data on routine use in men w/o risk factors and in women
• Concerns about use in healthy people or inappropriate patient populations
• No effect on total cardiovascular mortality
• No data on routine use in men w/o risk factors and in women
• Concerns about use in healthy people or inappropriate patient populations
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12Cardiovascular and Renal Drugs AC MeetingCardiovascular and Renal Drugs AC MeetingDecember 8, 2003December 8, 2003
Amendment to the TFM Amendment to the TFM June 13, 1996 June 13, 1996
Amendment to the TFM Amendment to the TFM June 13, 1996 June 13, 1996
In response to 2 CPs requesting:
• an indication for use of aspirin in treating acute MI: initial dose of 160 mg to 162.5 mg continued daily for at least 30 days
In response to 2 CPs requesting:
• an indication for use of aspirin in treating acute MI: initial dose of 160 mg to 162.5 mg continued daily for at least 30 days
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13Cardiovascular and Renal Drugs AC MeetingCardiovascular and Renal Drugs AC MeetingDecember 8, 2003December 8, 2003
1997 Advisory Committee Meeting 1997 Advisory Committee Meeting
CP requested an amendment to the CP requested an amendment to the professional labeling for aspirin in secondary professional labeling for aspirin in secondary
prevention of CV events in patientsprevention of CV events in patients::
1997 Advisory Committee Meeting 1997 Advisory Committee Meeting
CP requested an amendment to the CP requested an amendment to the professional labeling for aspirin in secondary professional labeling for aspirin in secondary
prevention of CV events in patientsprevention of CV events in patients::
• undergoing coronary, cerebral, or peripheral arterial revascularization procedures
• with chronic non-valvular atrial fibrillation
• requiring hemodialysis access with fistula or shunt
• with elevated risk due to some form of vascular disease
• undergoing coronary, cerebral, or peripheral
arterial revascularization procedures
• with chronic non-valvular atrial fibrillation
• requiring hemodialysis access with fistula or shunt
• with elevated risk due to some form of vascular disease
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14Cardiovascular and Renal Drugs AC MeetingCardiovascular and Renal Drugs AC MeetingDecember 8, 2003December 8, 2003
1997 Advisory Committee Meeting 1997 Advisory Committee Meeting RecommendationsRecommendations
1997 Advisory Committee Meeting 1997 Advisory Committee Meeting RecommendationsRecommendations
• Low-dose aspirin in patients with stable angina
• Low-dose aspirin in patients with arterial revascularization procedures
• Not indicated in patients with peripheral vascular disease
• Low-dose aspirin in patients with stable angina
• Low-dose aspirin in patients with arterial revascularization procedures
• Not indicated in patients with peripheral vascular disease
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15Cardiovascular and Renal Drugs AC MeetingCardiovascular and Renal Drugs AC MeetingDecember 8, 2003December 8, 2003
1998 Final Monograph1998 Final Monograph FDA’s Evaluation of the PHSFDA’s Evaluation of the PHS Reasons why the claim for primary preventionReasons why the claim for primary prevention
of MI was not included in the FMof MI was not included in the FM::
1998 Final Monograph1998 Final Monograph FDA’s Evaluation of the PHSFDA’s Evaluation of the PHS Reasons why the claim for primary preventionReasons why the claim for primary prevention
of MI was not included in the FMof MI was not included in the FM::
• Some subjects had prior MI
• 8% who suffered a nonfatal MI also had evidence of a previous MI
• No statistically significant effects of aspirin when fatal / nonfatal MI and stroke were combined
• Some subjects had prior MI
• 8% who suffered a nonfatal MI also had evidence of a previous MI
• No statistically significant effects of aspirin when fatal / nonfatal MI and stroke were combined
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16Cardiovascular and Renal Drugs AC MeetingCardiovascular and Renal Drugs AC MeetingDecember 8, 2003December 8, 2003
1998 Final Monograph1998 Final Monograph FDA’s Evaluation of the PHSFDA’s Evaluation of the PHS (con’t)(con’t)
1998 Final Monograph1998 Final Monograph FDA’s Evaluation of the PHSFDA’s Evaluation of the PHS (con’t)(con’t)
• Reduction in the incidence of fatal and non-fatal MI was accompanied by an increase in:
- hemorrhagic stroke - sudden death - other CV deaths
• BDT does not support the use of aspirin to prevent initial MI
• Reduction in the incidence of fatal and non-fatal MI was accompanied by an increase in:
- hemorrhagic stroke - sudden death - other CV deaths
• BDT does not support the use of aspirin to prevent initial MI
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17Cardiovascular and Renal Drugs AC MeetingCardiovascular and Renal Drugs AC MeetingDecember 8, 2003December 8, 2003
Professional LabelingProfessional LabelingProfessional LabelingProfessional Labeling
• Information does not appear on the OTC label
• Labeling is provided to healthcare professionals by manufacturers
• Prescribing information for:• vascular indications• revascularization procedures• rheumatologic diseases
• Information does not appear on the OTC label
• Labeling is provided to healthcare professionals by manufacturers
• Prescribing information for:• vascular indications• revascularization procedures• rheumatologic diseases
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18Cardiovascular and Renal Drugs AC MeetingCardiovascular and Renal Drugs AC MeetingDecember 8, 2003December 8, 2003
Professional LabelingProfessional Labeling (cont.)(cont.)Professional LabelingProfessional Labeling (cont.)(cont.)
Professional Labeling of Aspirin
Components of Professional Labeling
Warnings Precautions
Adverse Reactions
Overdosage
Dosage & Administration
Contraindications
Indications
![Page 19: Regulatory History of Aspirin Cardiovascular and Renal Drugs Advisory Committee Meeting Michelle M. Jackson, Ph.D. Division of Over-The-Counter Drug Products.](https://reader035.fdocuments.in/reader035/viewer/2022070400/56649f115503460f94c23be7/html5/thumbnails/19.jpg)
19Cardiovascular and Renal Drugs AC MeetingCardiovascular and Renal Drugs AC MeetingDecember 8, 2003December 8, 2003
Professional Labeling (cont.)Professional Labeling (cont.)Professional Labeling (cont.)Professional Labeling (cont.)
Vascular Indications
Indications Recommended Daily Dose(mg)
Ischemic Strokes / TIA 50 - 325
Suspected Acute MI 160 - 162.5
Prevention of Recurrent MI 75 - 325
Unstable Angina Pectoris 75 - 325
Chronic Stable Angina Pectoris 75 - 325
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20Cardiovascular and Renal Drugs AC MeetingCardiovascular and Renal Drugs AC MeetingDecember 8, 2003December 8, 2003
Professional Labeling (cont.)Professional Labeling (cont.)Professional Labeling (cont.)Professional Labeling (cont.)
Revascularization Procedures
Indications Recommended Daily Dose(mg)
Coronary Artery 325 Bypass Graft
Percutaneous Transluminal Presurgery: 325 Coronary Artery Postsurgery: 160 - 325
Carotid Endarterectomy 80 - 650
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21Cardiovascular and Renal Drugs AC MeetingCardiovascular and Renal Drugs AC MeetingDecember 8, 2003December 8, 2003
Bayer Healthcare’s RequestBayer Healthcare’s RequestBayer Healthcare’s RequestBayer Healthcare’s Request
• Professional labeling for the use of aspirin regimen (75-325 mg) for primary prevention of MI in patients at risk for a CHD
• Professional labeling for the use of aspirin regimen (75-325 mg) for primary prevention of MI in patients at risk for a CHD
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22Cardiovascular and Renal Drugs AC MeetingCardiovascular and Renal Drugs AC MeetingDecember 8, 2003December 8, 2003
![Page 23: Regulatory History of Aspirin Cardiovascular and Renal Drugs Advisory Committee Meeting Michelle M. Jackson, Ph.D. Division of Over-The-Counter Drug Products.](https://reader035.fdocuments.in/reader035/viewer/2022070400/56649f115503460f94c23be7/html5/thumbnails/23.jpg)
23Cardiovascular and Renal Drugs AC MeetingCardiovascular and Renal Drugs AC MeetingDecember 8, 2003December 8, 2003