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New Physician’s Labeling: Where is the Safety Information?

New Physician’s Labeling: Where is the Safety Information?. Rosemary Roberts, MD, FAAP Director Office of Counter-Terrorism and Pediatric Drug Development CDER. March 22, 2006. Rx Labeling Definitions. Label : Written, printed, or graphic matter

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New Physician’s Labeling: Where is the Safety Information?

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  1. New Physician’s Labeling: Where is the Safety Information? Rosemary Roberts, MD, FAAP Director Office of Counter-Terrorism and Pediatric Drug Development CDER March 22, 2006

  2. Rx LabelingDefinitions Label: Written, printed, or graphic matter on the immediate container of the drug product Labeling: Includes all labels, as well as other written, printed, or graphic matter accompanying the product

  3. Labeling

  4. Rx Labeling21 CFR 201.56 • Labeling is a summary of essential scientific information needed for safe and effective use of the drug • Informative, accurate and neither promotional in tone nor false or misleading • Based on data derived from human experience (whenever possible)

  5. Background • Previous labeling regulations finalized in 1979 • Increase in amount and complexity of drug information • Goal - more informative and accessible labeling, resulting in a better risk communication and management tool

  6. Background • Development process included • Focus groups, National physician survey, Public meeting, Written comments • Proposed rule issued December 2000 • Final rule published January 24, 2006

  7. Content Innovations • Highlights • Limited to ½ page • Bulleted Boxed Warning and Indications • Table of Contents (“Contents”) • Allows easy reference to full prescribing information (FPI) • Facilitates hyperlinks in electronic formats • Identifies and Dates “Recent Major Changes” • Captures Indications, D&A, Boxed Warning, CI and W&P • Referenced in Highlights; margin mark in FPI • Added date of initial US approval

  8. Example of Highlights for a Fictitious Drug

  9. Old Format Labeling

  10. Limitations Statement Product Names and Date of Initial US Approval Boxed Warning Major Recent Changes Indications and Usage Dosage & Administration Dosage Forms & Strengths Contraindications Warnings & Precautions Adverse Reactions Drug Interactions Use in Specific Populations Patient Counseling Information Statement Highlights of New Labeling

  11. Example of Highlights for a Fictitious Drug

  12. Boxed Warning 1 Indications & Usage 2 Dosage & Administration 3 Dosage Forms & Strengths 4 Contraindications 5 Warnings & Precautions 6 Adverse Reactions 7 Drug Interactions 8 Use in Specific Populations 9 Drug Abuse & Dependence 10 Overdosage 11 Description 12 Clinical Pharmacology 13 Nonclinical Toxicology 14 Clinical Studies 15 References 16 How Supplied/Storage & Handling 17 Patient Counseling Information Contents and Full Prescribing Information (FPI)

  13. Example of Contents for a Fictitious Drug

  14. Contraindications21 CFR 201.57(c)(5) • Describe those situations in which the drug should not be used because the risk of use clearly outweighs any possible therapeutic benefit • Known hazards and NOT theoretical possibilities

  15. Imdicon(cholinasol) • Contraindications • Hematopoietic disorders or a history of TTP or aplastic anemia • Hemostatic disorder or active bleeding • Severe hepatic impairment

  16. Warnings and Precautions21 CFR 201.57(c)(6) • Include clinically significant ARs observed in association with the use of a drug for which there is reasonable evidence of a causal association between drug and the AR (a causal relationship need not have been established)

  17. Warnings and Precautions21 CFR 201.57(c)(6) • Serious AR; or • Otherwise clinically significant • Require discontinuation • Dosage or regimen adjustment • Significantly affect patient compliance; or • Product interferes with a laboratory test

  18. Warnings and Precautions21 CFR 201.57(c)(6) • Include an AR which can be expected to occur with a drug based on observations from other members of the drug class or animal studies • Serious or otherwise clinically significant AR; and either • Based on what is known about the pharmacology, chemistry, or drug class, it seems likely that an AR will occur with the drug; or • animal data raises substantial concern for an AR in humans

  19. Warnings and Precautions21 CFR 201.57(c)(6) • Other factors to consider whether to include an AR in this section: • Indication • Incidence • Ability to manage or prevent an adverse reaction (through patient monitoring, dose selection or titration, avoiding a concomitant therapy)

  20. Warnings and Precautions21 CFR 201.57(c)(6) • Neutropenia (2.4% incidence; may occur suddenly; typically resolves within 1-2 weeks of discontinuation), thrombotic thrombocytopenic purpura (TTP), aplastic anemia, agranulocytosis, pancytopenia, leukemia, and thrombocytopenia can occur (5.1) • Monitor for hematological adverse reactions every 2 weeks through the third month of treatment (5.2)

  21. Boxed Warning21 CFR 201.57(c)(1) • When to use a boxed warning: • Adverse reaction (AR) so serious in proportion to the potential benefit from the drug that it is essential the AR be considered in assessing the risks and benefits of using the drug; OR • Serious adverse reaction that can be prevented or reduced by appropriate use of the drug; OR • Drug approved with restrictions to assure safe use; distribution or use restriction

  22. Boxed Warning21 CFR 201.57(c)(1) • Ordinarily based on clinical data, but serious animal toxicity may also be the basis in absence of clinical data

  23. Example of Highlights for a Fictitious Drug

  24. WARNING: LIFE-THREATENING HEMATOLOGICAL ADVERSE REACTIONS See full prescribing information for complete boxed warning Monitor for hematological adverse reactions every 2 weeks for first 3 months of treatment (5.2). Discontinue Imdicon immediately if any of the following occur: • Neutropenia/agranulocytosis (5.1) • Thrombotic thrombocytopenic purpura (5.1) • Aplastic anemia (5.1)

  25. Boxed Warnings: Balancing the Risk/Benefit • Multi-layered process • Internal: statisticians, toxicology, safety reviewer, medical reviews, clinical pharmacology • External: Advisory Committee input • Consensus decision • Iterative process with the sponsor

  26. Resources on FDA’s Website Dedicated Web page http://www.fda.gov/cder/regulatory/physLabel/default.htm • Final rule • Guidance for Industry • Implementing the new labeling content and format (draft) • Adverse reactions section (final) • Clinical studies section (final) • Warnings and Precautions, Contraindications and Boxed Warning sections (draft) • Examples of labeling in the new format for fictitious drugs • Information sheets for healthcare professionals and consumers

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