Transcript Slide 1

Recalls: The First Smoke of A Mass Tort
Overview of a Recall of an FDA-Regulated Product
Food & Drug Law Institute
Conference on Products Liability
For FDA Regulated Products
January 26, 2005
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 longterm – 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 1270.43
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 314.81(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.
http://www.fda.gov/ora/compliance_ref/recalls/ggp_recall.htm
– Regulatory Procedures Manual. March 2004. Chapter
7. Recall Procedures.
http://www.fda.gov/ora/compliance_ref/rpm/pdf/ch7.pdf
• 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, e-mail, 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 92024
Phone 760.633.3343
Fax 760.633.3501
Cell 760.815.4762
D.C. Office 202.730.4123
[email protected]
www.weinberggroup.com
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