1 / 16

Labeling and Electronic Initiatives

Labeling and Electronic Initiatives. Rachel E. Behrman M.D., M.P.H. Deputy Director, Office of Medical Policy CDER FDA Science Board, April 15, 2005. Authority. Sec. 502(a) – A drug or device shall be deemed to be misbranded if its labeling is false or misleading in any particular

cynthia-warren
Download Presentation

Labeling and Electronic Initiatives

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Labeling and Electronic Initiatives Rachel E. Behrman M.D., M.P.H. Deputy Director, Office of Medical Policy CDER FDA Science Board, April 15, 2005

  2. Authority • Sec. 502(a) – A drug or device shall be deemed to be misbranded if its labeling is false or misleading in any particular • Sec. 505(d)(7) – If the Secretary finds…such labeling is false or misleading in any particular; he shall issue an order refusing to approve the application • 21CFR 201.57 – Specific requirements on content and format of labeling for human prescription drugs

  3. Description Clinical Pharmacology Indications and Usage Contraindications Warnings Precautions Adverse Reactions Drug Abuse and Dependence Overdosage Dosage and Administration How Supplied May Contain: Animal Pharmacology &/or Toxicology Clinical Studies References Current Labeling

  4. Physician Labeling Rule - Background • Goal - more informative and accessible labeling, resulting in a better risk communication and management tool • Development process included • Focus groups • National physician survey • Public meeting • Formal notice and comment rulemaking process with review of comments on proposed rule

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

  6. Limitations Statement Product Names Boxed Warning Recent Changes Indications and Usage Dosage & Administration Contraindications Warnings & Precautions Adverse Reactions Drug Interactions Use in Specific Populations Patient Counseling Information Statement Highlights

  7. Some Format Innovations • Establish format requirements • Minimum 8-point font (note comments to exempt trade labeling that accompanies drug product) • Standardized bolding and “white space” • Reorder and reorganize sections • Frequently referenced information moved forward • Consolidate safety information into new Warnings andPrecautions section

  8. Some Content Innovations • Highlights • Limit to ½ page • Bullet information • Index • Allow easy reference to full prescribing information • Allow hyperlinks in electronic formats • Identify and date major changes • Emphasize “Patient Counseling Information” • Provide greater clarity in requirements (e.g., Adverse Reactions)

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

  10. Companion Initiatives • Guidance • Labeling Content and Format • Adverse Reactions • Clinical Studies • Warning and Precautions, Contraindications and Boxed Warning • Health Information Technology PLR provides concise, consistent, reliable information that can be manipulated electronically

  11. Structured Product Labeling • SPL Content of labeling in a standardized electronic file format with tagged blocks of text and data elements • Substance Registration System (SRS) and Unique Ingredient Identifiers (UNII) • ELIPs (processing system) • DailyMed Electronic repository of current labeling managed by NLM updated daily by FDA • Medicare Modernization Act Requires uniform standards for medication information

  12. <Description> This is the description of this product <Indication and Usage> This is the indication of the product <Contraindications> These are the contraindications <Warnings> These are the warnings <How supplied> This is how the product is supplied Example PDF SPL Description: This is the description of the product Indications and Usage: This is the indication for use of this product Contraindications: These are the contraindications Warnings: These are the warnings. How supplied: This is how the product is supplied. 12

  13. ELIPs - Functions • Receive SPL • Validate • Reject • Notify labeling authority • Provide review tools • Search • View • Compare • Edit • Transmit SPL after 1 business day lag 13

  14. Overview of Information Flow NLM Applicant SPL SPL + Electronic documents SPL + supporting documents CDR EDR SPL + metadata ELIPS Tracking information with submission identifier COMIS UNII SRS/CID

  15. SPL Project • Phase I: SPL for approved prescription drugs • Target: October 2005 • Systems • Electronic Labeling Information Processing System (ELIPs) • Substance Registration System (SRS) • Phase II – SPL for unapproved prescription and OTC drugs • Target: August 2006 • Systems • Electronic Listing System (eList) • Drug Facility Registration Module (DFRM) 15

  16. Summary • FDA will provide accurate, up-to-date drug information (labeling) • In a readable, accessible format • In a electronically manipulatable form (SPL), delivered daily to NLM (Daily Med) • Drug information initiatives support • Electronic prescribing • Electronic health record • Decision support software

More Related