FDA Recalls and Consumer Complaints

Transcription

1 FDA Recalls and Consumer Complaints Los Angeles Customs Broker and Freight Forwarders Association Meeting March 15, 2012 Larry Howell, CDR, USPHS Deputy Director, Import Operations Branch U.S. Food & Drug Admin., Los Angeles District

2 November 8, 1937 Letter to President Roosevelt Let me take few moments to read you a letter that was written to President Roosevelt November 8, 1937 by Mrs. Maise Nidiffer of Tulsa, OK.

3 Elixir Sulfanilamide disaster of 1937

4 Elixir Sulfanilamide disaster of 1937 Aside from the Pure Food and Drug Act of 1906 and the Harrison Act of 1914 banning the sale of some narcotic drugs, there was no federal regulatory control ensuring the safety of new drugs in 1937.

5 Elixir Sulfanilamide disaster of 1937 In 1937, S. E. Massengill Company, a pharmaceutical manufacturer, created a preparation of sulfanilamide using diethylene glycol (DEG) as a solvent, and called the preparation "Elixir Sulfanilamide". DEG is poisonous to humans, but Harold Watkins, the company's chief pharmacist and chemist, was not aware of this (although it was known at the time).

6 Elixir Sulfanilamide disaster of 1937 The company started selling and distributing the medication in September By October 11, the American Medical Association received a report of several deaths caused by the medication. 105 deaths were blamed on the medication. There were 105 deaths and 248 survivors. Legend has it" that First Lady Eleanor Roosevelt read the letter.

7 Elixir Sulfanilamide disaster of 1937 Congress responded to public outrage & pressure from President Roosevelt by passing the 1938 Food, Drug, and Cosmetic Act, which required that companies perform animal safety tests on their proposed new drugs and submit the data to the FDA before being allowed to market their products. The Massengill Company paid a $26,100 fine under provisions of the 1906 Pure Food and Drugs Act, which prohibited labeling the preparation an "elixir" if it had no alcohol in it (the largest fine ever levied for violation of the 1906 FDA law).

8 Elixir Sulfanilamide disaster of 1937 Fortunately, because of the FDA's diligence, 228 of the 240 gallons of the elixir were retrieved before distribution. It is estimated that if all 240 gallons had been consumed, the number of deaths could have exceeded 4000 ( Recall Audit check ). Massengill's chemist, Harold Watkins, was later fired. He died of a self-inflicted gunshot wound while cleaning his handgun. It is unknown whether he committed suicide or if the death was an accident.

9 FDA/Industry

10 FDA 101: Product Recalls From First Alert to Effectiveness Checks

11 FDA Sample Collection & Analysis Other Health Agencies Firm Testing FDA inspection How Does FDA Learn About a Problem with a Regulated Product? Adverse Event Reports NDA Field Reports CDC Epidemiological Information 3 rd party information

12 Definitions 21CFR7.3 Recall Product Correction Market Withdrawal Stock Recovery Classification

13 Recall A firm s removal or correction of a marketed product(s) that the Food and Drug Administration considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure.

14 Product An article subject to the jurisdiction of the Food and Drug Administration, including any food intended for human or animal use

15 Correction Repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a product without its physical removal to some other location.

16 Market withdrawal A firm s removal or correction of a distributed product which involves a minor violation that would not be subject to legal action by the FDA or which involves no violation (normal stock rotation, routine equipment adjustments, etc.)

17 Stock recovery A firm s removal or correction of a product that has not been marketed or that has not left the direct control of the firm, i.e. the product is located on premises owned by, or under the control of, the firm and no portion of the lot has been released for sale or use.

18 Classification 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.

19 Health Hazard Evaluation Diseases or injuries which have already occurred Existing conditions that can contribute to a clinical condition Population Seriousness of hazard Likelihood of occurrence of hazard Immediate and long term consequences

20 Classification Class I is 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 Class I Examples Listeria monocytogenes, Salmonella, E. coli O157:H7 in RTE food Dietary supp. products containing aristolochic acid, a potent carcinogen and nephrotoxin Dietary supp. products containing a prescription drug that could have serious, lifethreatening consequences in some people. (Liqiang Dietary Supp. containing glyburide)

22 Additional Class I Examples Peanut butter contaminated with Salmonella. Under-processed canned chili that contained Clostridium botulinum toxin. Smoked salmon contaminated with Listeria monocytogenes (Lm). Ice cream that did not declare peanut-derived ingredients but contained peanut butter as an ingredient. Baby food that posed a choking hazard. Horse feed contaminated with elevated levels of monensin. Pet food contaminated with elevated levels of melamine and cyanuric acid. Sheep feed containing elevated levels of copper. Swine feed containing elevated levels of selenium.

23 Classification Class II is 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.

24 Class II examples Hard/sharp foreign objects 7 25 mm Undeclared yellow 5 & 6 Unapproved/uncertified colors Cosmetic products found to be contaminated with bacteria

25 Classification Class III is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.

26 Class III examples Mold, yeast, lactobacillus Hard/sharp foreign objects less than 7 mm Off odor/off taste from contaminant at levels not likely to pose a hazard to health Misbranded products (The label states zero mg potassium per serving; the product actually contains 370mg potassium per serving)

27 Recent Recall Issues Involving Imports Melamine contaminated pet food (China) APIs in "Dietary Supplements" for ED Ethylene glycol in toothpaste Heparin recall (China) Reports of anaphylactoid reactions after bolus administration

28 Code of Federal Regulations 21 CFR Part 7, Subpart C: Recalls (Including Product Corrections) Guidelines on Policy, Procedures, and Industry Responsibility Recall is a voluntary action by a firm (FSMA gives FDA mandatory recall authority for potential Class I recalls if firms don t initiate a voluntary recall) Guidance on development of recall strategy (depth, public warning, effectiveness checks) Guidance on recall communications with consignees Who to contact at FDA and what information to provide

29 Code of Federal Regulations 21 CFR Part 107, Subpart E Infant Formula Recalls (Gives FDA authority to require recalls of adulterated or misbranded infant formula that presents a risk to human health) 21 CFR Part 806-Medical Device Firm must report the recall to FDA and conduct the recall in the manner specified in this part (21 CFR Part 810-Procedures for FDA recall authority) 21 CFR Part Includes provisions for FDA to order retention, recall and/or destruction of Human Cell, Tissue and Cellular & Tissue-based products.

30 Press releases Issued by FDA or firm for almost all Class I recalls where the product is likely to be in the hands of the consumer May be issued by FDA or firm for some class II recalls Models for most class I recalls posted on FDA website Follow FDA models as closely as possible fill in the blanks

31

32 Steps Taken By a Firm When Conducting a Recall Scope the specific products to recall Strategy the plan to execute the removal or correction to minimize risk of illness/injury from recalled product Notification inform FDA of the planned recall; offering the opportunity to comment on the scope and strategy.

33 Steps Taken By a Firm When Conducting a Recall (cont d) Execution - make the recall happen; calls, s, faxes, letters, visits, internet posting, press releases Verification - ensure execution of the strategy was performed effectively Analysis - review overall effort and identify opportunities for improvement

34 Steps Taken By FDA in the Recall Process Assess situation & obtain recall related information (e.g. labeling, distribution, testing) Investigate - What went wrong? What steps were taken to prevent recurrence? Evaluate scope and strategy -Is it appropriate in light of the risk? Adjustments needed? Other steps needed? Additional public notice necessary?

35 Steps Taken By FDA in the Recall Process (cont d) Health hazard evaluation and classification of the recall; publication in the Enforcement Report Recall audit checks; level is set based on risk to verify the effectiveness of the recall efforts

36 Responsibilities of Recalling Firm Communicating with Consignees The FDA s current thinking interprets the provisions of 21 CFR 7.49 and to allow the use of and other electronic communication methods, such as fax or text messaging, to accomplish any recall notification or distribution of important safety information.

37 Responsibilities of Recalling Firm Communicating with Consignees Be brief and to the point Identify clearly the product, size, lot number(s), code(s) or serial number(s) and any other pertinent descriptive information to enable accurate and immediate identification of the product Explain concisely the reason for the recall and the hazard involved, if any

38 Responsibilities of Recalling Firm Communicating with Consignees Provide specific instructions on what should be done with respect to the recalled products Provide a ready means for the recipient of the communication to report to the recalling firm whether it has any of the product Provide sub-recall instructions (if necessary)

39 Responsibilities of Recalling Firm Recall Monitoring/Closure Maintain record of responses and re-contact non-responders Maintain record of units returned/reconditioned/destroyed Maintain returned product under quarantine Destroy/recondition product under FDA supervision Make corrections to minimize probability that problem will repeat

40 Responsibilities of the FDA DISTRICTS Submit a 24 hour alert of the recall to the affected FDA centers Collect information on the recall Offer guidance on recall (recall strategy & communications) Submit a recall recommendation to the affected FDA Center Monitor the recall

41 Responsibilities of the FDA DISTRICTS Witness product destruction or monitor the completion of an FDA approved reconditioning plan Initiate & monitor recall audit checks Notify the firm of recall classification and termination Terminate Class II and III recalls

42 Responsibilities of the FDA Centers Receive & review recall recommendations Initiate Health Hazard Evaluations (HHE) Review and evaluate the firm s recall strategy Update FDA s recall database with recall classification, strategy and recommendations. Place recall information on the FDA Enforcement Report (weekly notice of FDA regulatory activities) Terminate Class I recalls

43 FDA s Reportable Food Registry (RFR)

44 RFR At A Glance The RFR covers all foods regulated by FDA except infant formula and dietary supplements. The RFR was established to provide a reliable mechanism to track patterns of adulteration in food in order to support efforts by FDA to target limited inspection resources to protect the public health. Failure to report a reportable food is a prohibited act under the Federal Food, Drug, and Cosmetic Act

45 RFR At A Glance (cont d) Beginning September 8, 2009, the RFR required a responsible party to file a report through the RFR electronic portal at when there is a reasonable probability that the use of, or exposure to, an article of food will cause serious adverse health consequences or death to humans or animals. Such foods are Reportable Foods.

46 RFR At A Glance (cont d) Responsible party is defined as the person who submits the registration information to FDA for a food facility that manufactures, processes, packs, or holds food for human or animal consumption in the United States.

47 RFR At A Glance (cont d) FDA Los Angeles District contact regarding RFRs: Steven Porter* steven.porter@fda.hhs.gov Emergency Response Coordinator (949) (949) (BB) *New ERC pending

48 Recall Resources 21 C.F.R. PART 7 FDA REGULATORY PROCEDURES MANUAL, CHAPTER 7, RECALL PROCEDURES (MARCH 2006) FDA GUIDANCE FOR INDUSTRY, PRODUCT RECALLS, INCLUDING REMOVAL AND CORRECTION (NOVEMBER 2003) FDA INVESTIGATIONS OPERATIONS MANUAL, CHAPTER 7, RECALLS ACTIVITIES (2011)

49 Recall Contacts for LOS-DO Dyana Stone Office: (949) /BB: (949) /FAX: (949) Thanh Tran Office: (949) /BB: (949) /FAX: (949) Food and Drug Administration Fairchild Irvine, CA A current list of FDA recall coordinators can be found on FDA s website at:

50 Consumer Complaints

51 Definition Consumer Complaint A notification that a product in commercial distribution may be in violation of the laws or regulations administered by the FDA, may have caused an illness, injury, or death, or is alleged to have caused problems not covered by the above.

52 Background The Consumer Complaints System collects information on the condition of FDA regulated products on the market which consumers are dissatisfied with. This information can be compiled and evaluated to highlight current problems, long term trends and can be used as background data in the development of Center programs.

53 Recoding Complaints Complaints are logged into the FDA s Field Accomplishments and Compliance Tracking System (FACTS) Consumer Complaint System for each complaint received by telephone, mail, or in person from consumers. This action is done by a District Consumer Complaint (CC) Coordinator.

54 Time Frames Promptness of the follow up to a complaint is based on the seriousness of the complaint. Complaints of life threatening or severe adverse consequences are followed up immediately. Less serious injury/illness complaints are followed up within 1 2 days of receipt.

55 Compliant Follow-Up The CC Coordinator and his/her Supervisory Investigator determine the appropriate follow up and assign the complaint to a supervisory group for action. Non injury complaints are evaluated by the CC Coordinator to determine what follow up, if any, is required. Those complaints requiring routine follow up are sent to the State, District work plan folder, or file for coverage during the next scheduled inspection.

56 CC Coordinator for LOS-DO Frank Lee Office (CC Hotline): (949) FAX: (949)

57 Do you smell anything?

58 That s a cent!

59 Do you see any fruit?

60 That s a pear!

61 Do you see any snakes?

62 Three Copperheads!

63 Do you see any cars?

64 Four Lincolns!

65 Do you see any Disneyland tickets?

66 And you won t for a nickel!

67 Questions?