FDA/CBER Compliance Update. EBAA Leadership and Advocacy Meeting February 13, 2014 Mary Malarkey, Director Office of Compliance and Biologics Quality

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1 FDA/CBER Compliance Update EBAA Leadership and Advocacy Meeting February 13, 2014 Mary Malarkey, Director Office of Compliance and Biologics Quality

2 Summary Registration Inspections Regulatory Actions Deviation Reports Recalls 2

3 Establishment Registration Snapshot 4102 total (as of 22Jan2013) 1431 inactive 1037 musculoskeletal/ocular 809 hematopoietic progenitor stem cell (HPC) 705 reproductive 319 international (mostly HPC) Inact, 35% International, 8% MS/Oc, 26% HPC, 20% Repro, 18% MS/Oc HPC Repro Inact International Note: Number of establishments 3 by tissue type is not additive to the total because of overlap 3

4 How does this compare to past years? Year Total establishments MS/Oc HPC Repro Inactive International 2013* * As of 22 Jan

5 Inspections

6 HCT/P Inspections Inspections Performed in Fiscal Years 2005 to

7 Risk-based Inspections? ~600 inspections/yr ~2700 active establishments Need to use resources smartly Use of open source intelligence, complaints, other information (e.g. HCT/P deviation reports), to guide yearly priorities 7

8 Risk-based Inspectional Approach to Prioritizing HCT/P Inspections Inspectional Focus in FY-2012: HCT/P establishments that process fresh and/or frozen allografts Musculoskeletal tissue, skin, or cornea recovery establishments Newly registered establishments that recover and/or process musculoskeletal, skin, corneal tissues, or amniotic membrane Newly registered HCT/P establishments that handle reproductive tissues 8

9 Risk-based Inspectional Approach to Prioritizing HCT/P Inspections (cont) Inspectional Focus FY-2013 Certain private cord blood banks (cord blood stem cells regulated solely under section 361 of the PHS Act) Newly registered establishments that recover and/or process musculoskeletal, skin, corneal tissues, or amniotic membrane Newly registered HCT/P establishments that handle reproductive tissues

10 FY12 HCT/P Inspections Accomplished *Sum of individual inspections do not equal total due to some inspections that were conducted for products in multiple categories Type of HCT/P establishment # Inspections Accomplished Hours/ Inspection Reproductive tissues Cord blood stem cells Peripheral blood stem cells All other HCT/Ps (e.g. musculoskeletal, ocular, recovery, distributors) Total/Average 592*

11 FY13 HCT/P Inspections Accomplished *Sum of individual inspections do not equal total due to some inspections that were conducted for products in multiple categories Type of HCT/P establishment # Inspections Accomplished Hours/ Inspection Reproductive tissues Cord blood stem cells Peripheral blood stem cells All other HCT/Ps (e.g. musculoskeletal, ocular, recovery, distributors) Total/Average

12 HCT/P Inspection Results 40 Percentage of inspections resulting in issuance of Form FDA Fiscal Year 12

13 FDA Form 483 This document lists observations made by the FDA representative(s) during the inspection of your facility. They are inspectional observations, and do not represent a final agency determination regarding your compliance. If you have an objection regarding an observation, or have implemented, or plan to implement, corrective action in response to an observation, you may discuss the objection or action with the FDA representative(s) during the inspection or submit this information to FDA at the address above. 13

14 OAI/VAI/NAI? OAI Official Action Indicated objectionable conditions found that warrant action VAI Voluntary Action Indicated objectionable conditions found but do not meet the threshold for regulatory action NAI No Action Indicated no objectionable conditions found (generally no FDA-483) guidancecomplianceregulatoryinformation/u cm htm 14

15 FY12 HCT/P Inspection Classifications Type of HCT/P establishment NAI VAI OAI Reproductive tissues Cord blood stem cells Peripheral blood stem cells All other HCT/Ps (e.g. musculoskeletal, ocular, recovery, distributors) Total

16 FY13 HCT/P Inspection Classifications Type of HCT/P establishment NAI VAI OAI Reproductive tissues Cord blood stem cells Peripheral blood stem cells All other HCT/Ps (e.g. musculoskeletal, ocular, recovery, distributors) Total

17 Regulatory Actions

18 HCT/P Regulatory Actions 18

19 Regulatory Actions FY-12 Warning Letters = 8 Musculoskeletal - New Life Generation, Inc. Ocular - Lone Star Lions Eye Bank, Inc. Repro - Reproductive Medicine Institute IVF, LLC Repro - Gramercy Fertility Services Repro - Family Beginnings, PC Cell therapy - IntelliCell Biosciences, Inc. Cell therapy - Thomas E. Young, LLC Cell therapy - CellTex Therapeutics Corporation Untitled Letters = 3 Musculoskeletal Alabama Organ Center Repro Gramercy Fertility Services Repro California Fertility Partners Order to Cease Manufacturing of HCT/P =1 19

20 Order To Cease Manufacturing: Center for Reproductive Medicine To Dr. Stephen Welden dba Center for Reproductive Medicine. Issued September 7, FDA determined that the violations uncovered at Center for Reproductve Medicine, because of their serious nature, provided reasonable grounds to believe that there is a danger to health; Order was effective immediately. Ordered to continue to store HCT/Ps. TissueSafety/ucm htm 20

21 Regulatory Actions FY-13 Warning Letters = 7 Repro - Dr. Martin Balin; Repro - Olympia Women s Health Repro - Virginia Center for Reproductive Medicine Repro - The Center for Reproductive Medicine Musculoskeletal - RTI Biologics, Inc.; Musculoskeletal - Musculoskeletal Transplant Foundation Ocular - Tissue Bank International/The National Eye Bank Center Order to Cease Manufacturing of HCT/P = 2 Musculoskeletal - Pacific Coast Tissue Bank Repro - New York Fertility Institute 21

22 Regulatory Actions FY-13 (cont) Untitled Letters = Repro - Women s Health Consultants; Repro - Reproductive Institute of South Texas 351/361 - Surgical Biologics 351/361 - Accel Spine 351/361 - Tides Medical 351/361 - Castle Surgical 351/361 - Tri-State Biologics 351/361 - Osiris

23 Order To Cease Manufacturing, Recall and Destroy: Pacific Coast Tissue Bank To Pacific Coast and its owner Dr. Eli Gendler. Issued November 5, FDA determined that the violations uncovered at Pacific Coast, because of their serious nature, provided reasonable grounds to believe that there is a danger to health; Order was effective immediately nes/guidancecomplianceregulatoryinformation/co mplianceactivities/administrativeactionsbiologics/u CM pdf

24 Order To Cease Manufacturing: New York Fertility Institute To New York Fertility Institute and its medical director, Dr. Majid Fateh. Issued March 1, FDA determined that the violations uncovered at New York Fertility Institute, because of their serious nature, provided reasonable grounds to believe that there is a danger to health; Order was effective immediately TissueSafety/ucm htm 24

25 Most Common Issues Identified in Eye Banks - FY13 Facility cleaning/sanitation (21 CFR ) SOP not updated for new lab area Outdated SOP in use Not following SOP Environmental control and monitoring (21 CFR ) Biological Safety Cabinets not maintained Room/surfaces/personnel not maintained Lack of response to positive results as per SOP

26 Most Common Issues Identified in Eye Banks - FY13-2 Equipment cleaning/maintenance (21 CFR ) Autoclaves not maintained as per SOP Autoclave failures not documented as per SOP Records (21 CFR ) Records of telephone next-of-kin interview not consistent with responses provided Overwrites/cross-outs

27 Other Issues Identified in Eye Banks FY 12 - FY13 Failure to retain records for 10 years Records not accurate, indelible, legible, Failure to establish and maintain procedures to meet core GTP requirements Failure to validate processes

28 HCT/P Deviation Reports

29 HCT/P Deviation Reporting Tissue HCT/P Deviation Code FY11 FY12 FY13 Donor Screening (DS) Donor Eligibility (DE) Donor Testing (DT) Receipt, Pre-Distribution, Shipment & Distribution (SD) Labeling Controls (LC) Processing & Processing Controls (PC) Supplies and Reagents (SR) Equipment (EQ) Recovery (RE) Environmental Control (EC) Storage (ST) Total

30 HCT/P Deviation Reporting Tissue FY11 FY12 FY13 Total Reports Electronic Reports 90 (85%) 122 (94%) 181 (93%) 30

31 Tissue HCT/P Deviation Reports FY-2013 Donor Screening 92 (up from 39 in FY-2012) Donor screening performed incorrectly (incomplete or inaccurate) in the donor medical history interview 82 Identified through audit of contractor performing donor screening Donor screening not performed or documented 4 31

32 Tissue HCT/P Deviation Reports FY-2013 Donor Eligibility 29 (down from 37 in FY-2012) Ineligible donor accepted Risk factors, clinical evidence or physical evidence identified 15 Donor incorrectly or not evaluated for plasma dilution 9 Donor reactive for relevant communicable disease 4 32

33 Tissue HCT/P Deviation Reports FY-2013 Donor Testing 21 (up from 17 FY-2012) Unacceptable samples were used for testing 14 (most involved using filtered samples) Required test used was not licensed, approved, or cleared

34 RECALLS

35 Outline What is a recall? What is recall classification? What is Industry s role? FDA s role? Recall numbers Direct Recall Classification System 35

36 Definition - Recall A firm s removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g. seizure. Does not include a market withdrawal or stock recovery 21 CFR 7.3 (g) 36

37 Definition - Market Withdrawal Removal or correction of a distributed product Involves minor violation that would not be subject to legal action by the agency OR No violation 21 CFR 7.3 (j) 37

38 Voluntary Recalls initiated by manufacturers and distributors under 21 CFR 7.40(a) FDA Initiated Recalls Are rare For HCT/Ps two recall orders since 2000 under the tissue regulations CryoLife Pacific Coast Tissue Bank

39 Recall Classifications The numerical designation, i.e. I, II, or III, assigned by the Food and Drug Administration to a particular product recall to indicate the relative degree of health hazard presented by the product being recalled. 21 CFR 7.3(m) 39

40 HEALTH HAZARD EVALUATION An evaluation by FDA medical staff of the threat to health presented by a product, that is being recalled or considered for recall 21 CFR 7.41 FDA s review often includes the product s labeling and/or promotional literature 40

41 Definition - Recall Classifications Class I A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. 21 CFR 7.3 (m)(1) 41

42 Definition - Recall Classifications Class II A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 21 CFR 7.3 (m)(2) 42

43 Definition - Recall Classifications Class III A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. 21 CFR 7.3 (m)(3) 43

44 Industry and FDA s Roles Industry Notifies consignees and local FDA district office Monitor effectiveness of the recall/market withdrawal and provide updates to FDA at a frequency commensurate with the urgency (e.g. more frequent for Class I) May request termination of the recall/market withdrawal 44

45 Industry and FDA s Roles FDA Advise on language in notification letter Monitor effectiveness based on reports from industry and conduct audit checks at industry and consignee level Classify the recall/market withdrawal when needed information received and HHE completed Notify public through FDA Enforcement Report posted each week (may post earlier on center website) Terminate recall when all reasonable efforts have been made to notify consignees and remove product. 45

46 HCT/P Recalls FY13 as of 6/30/

47 Classified Recall Events FY12 HCT/P Recalls CBER Total Recalls * (all products) FY 12 Class I 1 1 FY 12 Class II FY 12 Class III

48 FY08-13 Voluntary Recalls CBER Regulated Products Product FY08 FY09 FY10 FY11 FY12 FY13 Blood Source Plasma Derivative IVD Vaccine Allergenic Device HCT/P TOTAL

49 Recall Numbers Highest number of voluntary recalls are associated with donated blood. Generally associated with one donor but can be more far reaching e.g. sterility concern with specific phlebotomist not swabbing arms properly could affect many components and be a Class II recall. Increase in tissue recalls in FY12 due to preparation for the switch from traditional to electronic processing system, i.e. clearing the backlog. Not representative of the year itself. 49

50 Direct Recall Classification DRC DRC is the classification of voluntary biologic recalls directly by CBER personnel. Designed to utilize current information technology to streamline recall classification of biological products Time and resources previously needed to review and classify biologic recalls has been greatly reduced. Biologic recalls are posted in the public domain in a more timely manner 50

51 Direct Recall Classification DRC DRC Timeline March 2009 DRC implemented for blood & source plasma recalls November DRC expanded to accommodate classification of 100 blood and source plasma products June 2012 DRC expanded to accommodate classification of non-blood products, ie HCT/Ps, vaccines, allergenics, derivatives, etc

52 Direct Recall Classification DRC DRC Process BPDRs and HCT/P Deviation Reports are reviewed within days of receipt Follow-up contact is made by phone and . Additional information frequently collected: Clarify Deviation Consignee notification is appropriate (21 CFR 7.46(c)) Updated final dispositions Periodic Recall Updates (for large recalls) 52

53 Direct Recall Classification DRC DRC Related Data FY12 Number of Additional Information Request Sent during FY Number of Alerts to Possible Recall Sent FY Number of DRC Recalls Classified FY

54 FY12 Class I HCT/P Recall Tissue allografts recovered from a donor where infectious disease testing was incorrectly performed and recipients are at increased risk for HCV transmission (1 cardiac allograft & 43 musculoskeletal allografts) No international distribution of HCT/Ps The original negative HCV NAT test result had been incorrect, and the donor blood specimen was actually positive for HCV by NAT December 23, 2011, MMWR Transmission of Hepatitis C Virus Through Transplanted Organs and Tissue Kentucky and Massachusetts, m?s_cid=mm6050a1_w 54

55 FY13 Class I HCT/P Recalls 3 Class I recalls involved tissue allografts potentially contaminated with Clostridium sp., that were distributed by 3 different establishments (no international distribution) 1 recall (Class I criteria) was ordered by FDA (Pacific Coast Tissue Bank) and involved over 40,000 bone products (distributed worldwide) 55

56 Vision for CBER CBER uses sound science and regulatory expertise to: Protect and improve public and individual health in the US and, where feasible, globally Facilitate development, approval of and access to safe and effective products and promising new technologies Strengthen CBER as a preeminent regulatory organization for biologics INNOVATIVE TECHNOLOGY ADVANCING PUBLIC HEALTH

57 Public Access to CBER CBER website: Phone: or Consumer Affairs Branch (CAB) Phone: Manufacturers Assistance and Technical Training Branch (MATTB) Phone: Follow us on Twitter https://www.twitter.com/fdacber

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