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Regulatory History of Aspirin

Regulatory 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 AC Meeting December 8, 2003. Content. The OTC Drug Monograph Process

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Regulatory History of Aspirin

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  1. Regulatory 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 AC Meeting December 8, 2003

  2. Content • The OTC Drug Monograph Process • Regulatory History of Aspirin • 1989 & 1997 Advisory Committee Discussions • Professional Labeling for Aspirin

  3. OTC Drug Monograph Process 1. Advisory Review Panels Panels 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)

  4. OTC 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

  5. OTC Drug Review (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

  6. Regulatory 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

  7. 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

  8. ANPR – July 8, 1977Panel’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

  9. TFM – 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

  10. Comments 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

  11. 1989 Advisory Committee Meeting (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

  12. Amendment to the TFM 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

  13. 1997 Advisory Committee Meeting CP requested an amendment to the professional labeling for aspirin in secondary prevention 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

  14. 1997 Advisory Committee Meeting Recommendations • 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

  15. 1998 Final MonographFDA’s Evaluation of the PHSReasons why the claim for primary preventionof 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

  16. 1998 Final MonographFDA’s Evaluation of the PHS(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

  17. Professional 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

  18. Professional Labeling(cont.) Components of Professional Labeling Contraindications Adverse Reactions Professional Labeling of Aspirin Precautions Warnings Overdosage Indications Dosage & Administration

  19. Professional Labeling (cont.)

  20. Professional Labeling (cont.)

  21. Bayer 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

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