Food & Drug Law Institute Conference on Products Liability For FDA Regulated Products January 26, 2005 Recalls: The First Smoke of A Mass Tort Overview of a Recall of an FDA-Regulated Product Michael A. Swit, Esq. Vice President, Life Sciences

My Objectives Today Review key rules or requirements that apply to recalls –What is a recall and what is not –What FDA’s authority is relative to recalls – e.g., can it order a recall? –How FDA deals with recalls and how industry interacts with the agency, including information FDA expects from a recalling firm How FDA expects public notification to be handled Classifying recalls by health hazard profile –Handling the recall logistically Understand how recall handling can set the tone for potential products liability exposure post-recall

Defining “Recall” Recall means a firm`s removal or correction of a marketed product 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. Recall does not include a market withdrawal or a stock recovery. 21 CFR 7.3(g)

Defining …“Correction” Correction means repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a product without its physical removal to some other location. 21 CFR 7.3(h)

Defining … “Market Withdrawal” Market withdrawal means 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 Food and Drug Administration or which involves no violation, e.g., normal stock rotation practices, routine equipment adjustments and repairs, etc. 21 CFR 7.3(j)

Defining … “Stock Recovery” Stock Recovery – a firm’s removal or corrections 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 the premises owned by or under the control of the firms and no portion of the lot has been released for sale or use.

Defining … “Recall Strategy” A planned specific course of action to be take in conducting a specific recall, which addresses the depth of the recall, need for public warnings, and extent of effectiveness checks for the recall. 21 CFR 7.3(l)

Defining … “Recall Classification” The numerical (Roman) designation, i.e., I, II, or III, assigned by FDA to a particular product recall to indicate the relative degree of health hazard presented by the product being recalled. 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.

Defining … “Recall Classification” … 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. Class III – a situation in which use of, or exposure to, a violative product is not likely to cause adverse consequences.

Classification – Evaluating Health Hazard – 21 CFR 7.41 You must do it; and FDA also will do it and its decision will govern; rarely reversed Factors addressed in a Health Hazard Evaluation (“HHE”) –Has disease or injury occurred due to use of (violative) product? –Could existing conditions contribute to a clinical situation that could expose humans (or animals) to a health hazard? –How will the hazard impact (e.g., differently) various population segments?

Classification – Evaluating Health Hazard … Factors addressed in HHE… –Degree of seriousness of HH to which at risk populations would be exposed –Assessment of likelihood hazard will occur –Assessment of consequences – immediate or long- term – if hazard occurs

Can FDA Make You Recall? General rule: No. But, FDA: “if we request, we will seize if you don’t” –FDA Regulatory Procedures Manual (RPM) – if FDA requests, it is usually a Class I scenario Statutory and regulatory exceptions: –Infant formula –Medical Device recall/notification authority – §518(e) –Biological products under the National Childhood Vaccine Safety Act of 1986 –Human tissue – 21 CFR

Do You Have to Tell FDA You’re Doing A Recall? Technically – not always –“Exceptions” involving notice that will trigger recall as an issue for you and FDA Field Alert – 21 CFR (b)(1) – 3 working days notice to your local FDA district office any time NDA holder learns: –Info that its drug or labeling could be mistaken for, or applied to another article (e.g., label mix-ups) –Info about: »Any bacteriological contamination »Any significant chemical, physical or other change or deterioration in distributed drug; or »Any failure of a batch to meet its specification ANDA Stability Commitment – signed part of ANDA that you will recall any batch that falls out of specification.

Do You Have to Tell FDA You’re Doing A Recall … –“Exceptions” … PMA Conditions of Approval – must report to FDA within 10 days after the applicant receives or has knowledge of information concerning: –A mix-up of the device or its labeling with another article. –Any adverse reaction, side effect, injury, toxicity, or sensitivity reaction attributable to the device and: »not addressed by the device's labeling; or »addressed by device labeling but occurring with unexpected severity or frequency. –Any significant chemical, physical or other change or deterioration in the device, or any failure of the device to meet the specifications established in the approved PMA that could not cause or contribute to death or serious injury but are not correctable by adjustments or other maintenance procedures described in the approved labeling Practically – yes; FDA expects it

Information FDA Expects On a Recall That Could Come Back to Haunt You Sources: –GUIDANCE FOR INDUSTRY – Product Recalls, Including Removals and Corrections. –Regulatory Procedures Manual. March Chapter 7. Recall Procedures. Be very careful – this information will be discoverable

Information FDA Wants in a Recall Submission … Reason for Recall (Guidance Item #A-6) –How product is defective or violative –How defect affects performance or safety –How the problem occurred and when –How discovered and when –Complaints associated with product/problem Health Hazard Evaluation – (Guidance Item #A-7) -- your assessment of health risk associated with “deficiency”

Information FDA Wants in a Recall Submission … Recall Strategy (Recall Guidance #A-10) – –Depth of recall – wholesaler, retail, consumer –Notification process –Effectiveness check strategy Public Notification (Recall Guidance, Part B) –Press release – “usually appropriate” if a significant health hazard and recalled product in hands of consumers Consult with district office recall coordinator before issuing “whenever possible”

Recall Effectiveness Checks Level A – 100% of consignees Level B – between 10% and <100% of consignees Level C – 10% Level D – 2% Level E – no checks

Evaluation of Recall Per Recall Guidance (Item C), FDA expects you to take two additional key steps after your recall: –Root Cause Analysis –Corrective Action Plan to prevent future occurrences

Timing Rules FDA –Field Alerts – 3 “working” days –PMA Reports – 10 days SEC –8-K’s – for certain specified and “other events” – supposed to implement SOX "real time issuer disclosure" requirement – within 4 business days of the event General good sense – correlate to health hazard

Vioxx – Recall, Correction or Withdrawal? Not a correction – did not remain on market Not a recall – no allegation to date by FDA or recalling firm that legal violation occurred Market Withdrawal –Based on (publicly available) knowledge at time Merck acted, this is the closest definition –Consistent with FDA contemporaneous descriptions at the time, which did not use “recall”

Questions? Call, , fax or write: Michael A. Swit, Esq. Vice President, Life Sciences THE WEINBERG GROUP INC. 336 North Pacific Coast Hwy. 101 Suite C Encinitas, CA Phone Fax Cell D.C. Office

For more than twenty years, leading companies have depended on THE WEINBERG GROUP when their products are at risk. Our technical, scientific and regulatory experts deliver the crucial results that get products to market and keep them there.