Drug and Biologic Recalls
American Conference Institute
Summit on Drug and Device Product Recalls
Philadelphia, PA
James S. Cohen, Esq.
202.756.8276
jscohen@mwe.com
March 21, 2011
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Drug and Biologic Recall Overview
 FDA: alternative method to remove or correct marketed
products deemed to pose risk to public health
 Applicable laws and policy regulations relating to drugs and
biologics
– 21 C.F.R. Part 7, Subpart C (Recalls – Guidance on Policy,
Procedures, and Industry Responsibility)
– 42 U.S.C. § 262 (biological products)
– 21 C.F.R. § § 1270.43, 1271.440 (HCT/Ps)
– 5 U.S.C. § 554 (Adjudications)
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Drug and Biologic Overview, Cont.
 Voluntary vs. Mandatory
 Policy and Process
 Relation to current Good Manufacturing Practice (cGMP) and
current Good Tissue Practice (cGTP) and corrective actions
 Other enforcement
 Planning and Interacting with FDA
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Part 7
 Sets forth basic framework for recalls
– Recall Policy, Health Hazard Evaluation, Strategy, procedures
– Company’s Responsibilities
– FDA’s responsibilities
 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
 Is not a market withdrawal and stock recovery
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Part 7, Cont.
 Market withdrawal: when a distributed product is removed
by a firm for a minor violation that would not be subject to
legal action by the FDA, or which involved no violation. For
example,
– normal stock rotation practices
– routine equipments adjustments/repairs
 Stock Recovery: when a firm conducts a removal or
correction of a product that has not been marketed, or has
not left the immediate control of the firm -– product is located on premises owned by or under control of the firm,
and no portion of the product lot has been released for sale or use
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Part 7, Cont.
 Correction: the repair, modification, adjustment, relabeling,
destruction, or inspection (including patient monitoring) of a
product without its physical removal to some other location
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Part 7, Cont.
– Class I recall: 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
– Class II recall: 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 recall: a situation in which use of or exposure to a violative
product is not likely to cause adverse health consequences.
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Voluntary vs. Mandatory
 Most recalls are voluntary
 A firm may voluntarily initiate a recall
 FDA may request a firm to voluntarily initiate a recall
 Biological products: FDA may order a mandatory recall of biological
products under the Public Health Service Act (PHSA)
 FDA may order a mandatory recall of a human cell, tissue and cellular
and tissue-based product (HCT/P) under 21 C.F.R. Part 1270
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Part 7 – Policy and Process
 FDA’s recall policy:
– Considered to be an effective method of removing or correcting
consumer products that are in violation of FDA laws
• Firms conduct voluntary recalls to “carry out their responsibility to protect
the public health and well-being from products that present a risk of injury
or gross deception or are otherwise defective”
 Firm-initiated recall
– A manufacturer or distributor (often set out in contract) decides to
initiate a recall, contacts and provides information to the FDA, such as
• identity and amount of product, reason for the removal or correction, firm’s
risk evaluation, copy of recall communication, and proposed recall strategy
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Part 7 – Policy and Process
 FDA district office:
– Submits Recall Alert to Center Recall Unit (CRU) and ORA Office of
Enforcement (headquarters)
– Gathers product information, and may conduct inspection
– Submits a recall recommendation and other information about the
product to Center (CDER or CBER)
– Offers guidance to firm
– Monitors the recall
– When complete, terminates Class II and II recalls, recommends
termination of Class I recalls
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Part 7 – Policy and Process
 District may conduct an establishment inspection for a Class
I or significant Class II recall
– Assess root cause(s) of problem
– Obtain/review firm’s corrective action plan
– Document violations for possible regulatory action if no correction
action
– Assess overall compliance
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Part 7 - Policy and Process
 Center’s recall staff (RCU):
– Initiate a health hazard evaluation
• Will have a HHE committee comprised of appropriate experts
• May use precedent HHE’s
– Finalize a recall strategy
– Classify the recall
– Update FDA’s Recall Enterprise System (RES) with classification,
audit strategy, and any recommendations, then post the information to
the FDA’s website
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Part 7 – Policy and Process
 Recall strategy:
– Developed by Agency for FDA-requested recall, and by firm for firminitiated recall, and suited to each individual case
• Results of HHE
• Ease in identifying the product
• Degree to which deficiency is obvious to consumer
• Degree to which product remains unused in marketplace
• Continued availability of essential products
– Particularly relevant for biological products
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Part 7 – Policy and Process
 Elements of Recall Strategy:
– Depth of recall
– Public warning
– Effectiveness check level
• Verify that all specified consignees have received notification of the recall and have
taken appropriate action
• Center Recall Unit will review or develop recall strategy
 District Office will coordinate with and notify firm by letter of Agency
assessments and determinations
– Includes notification that recall has been posted to the FDA website
– requests periodic status reports
– advises that failure to conduct effective recall could result in seizure of
violative product or other legal sanctions
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Part 7 – Policy and Process
 Termination of a recall:
– When district office determines all recall activity, including monitoring
and product disposition, has been completed
– Center concurrence needed for termination of Class I recall
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Biological Products
 FDA may order a mandatory recall for a biological product
 A “biological product” is “a virus, therapeutic serum, toxin,
antitoxin, vaccine, blood, blood component or derivative,
allergenic product, protein (except any chemically
synthesized polypeptide) or analogous product, or
arsphenamine or derivative of arsphenamine (or any other
trivalent organic arsenic compound), applicable to the
prevention, treatment, or cure of a disease or condition of
human beings” 42 U.S.C. § 262(i)
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Biological Products
 Mandatory recall authority (42 U.S.C. 262(d)):
– If FDA determines that a batch, lot, or other quantity of a licensed
product presents an imminent or substantial hazard to the public
health
• The Agency shall issue an order immediately ordering the recall of the
batch, lot, or other quantity of product.
• The order shall be issued in accordance with 5 U.S.C. 554 – requires
opportunity for a hearing
– Civil penalty up to $100,000 per day for each violation
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HCT/Ps
 HCT/Ps regulated solely under 42 U.S.C. § 361 (PHSA) are subject to the FDA’s
donor eligibility, establishment registration and listing, and cGTP requirements
 For these products, FDA may issue an Order of Retention, Recall, Destruction,
and Cessation of Manufacturing
– For human tissue intended for transplantation recovered prior to 5/25/05 (21
C.F.R. § 1270.43)
– For human cell, tissue, and cellular and tissue-based products (HCT/Ps)
(21 C.F.R. § 1271.440)
• Part of the Agency’s current Good Tissue Practice regulatory framework
• May be issued to prevent the introduction, transmission, or spread of
communicable disease (42 U.S.C. § 264)
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HCT/Ps
 FDA may order a recall (and/or detention) when there are
reasonable grounds to believe that a HCT/P is
– violative because manufactured in violation of Part 1271 and,
therefore, the conditions of manufacture do not provide adequate
protections against the risk of communicable disease, or
– the HCT/P is infected or contaminated so as to be a source of
dangerous infections to humans, or
– The establishment is otherwise in violative of Part 1271 (current Good
Tissue Practice)
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HCT/Ps
 If reasonable grounds exist to believe that there is a danger
to health, the order will be effective immediately
 Otherwise, effective after the passage of five days from the
establishment's receipt of the order, or if a Part 16 hearing is
requested, a decision is made effectuating the order
 Establishment may request Part 16 hearing within five
working days of receipt of the recall or detention order (but
not held in abeyance)
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Relation of Recall to cGMP/CGTP
 Depending on the cause of the recall and/or the results of
FDA inspection, cGMP or CGTP issues may be at issue
– Review situation to determine root cause(s)
– Determine what specific and/or systemic corrective actions, if any, are
necessary
– If FDA’s inspects, or if recall is significant, FDA will look at these
activities, and at effectiveness of recall, with expectations
– Product liability considerations
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Other Enforcement
 If the underlying cause(s) of recall are not addressed and
resolved, or if FDA concludes that the recall was not effective
– FDA may inspect at any time and determine other violations exist
requiring corrective or remedial action
– For HCT/Ps, Order of Destruction, Order of Cessation of
Manufacturing
– Warning Letter, seizure, injunction, prosecution
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Planning and Interaction with FDA
 Response to recall event should be robust, comprehensive,
and proactive
 Firm should present all analyses and proposed plan to FDA
at the time of notification, if possible
 Involve scientific staff in HHE and other aspects of recall
strategy and plan (FDA will doing the same on its end)
 Firm should include own health hazard evaluation and
proposed recall classification (I, II, or III) to FDA
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Planning and Interaction with FDA
 Firm should prepare and be ready to issue its own notice to
customers in lieu of or in advance of FDA press release
 Firm should maintain constant and regular contact with
district office during recall period
 Firm should always be one step ahead of FDA in planning
complete recall strategy, or FDA will set it for the firm
 Importance of well-reasoned and well-presented basis for
recall strategy (including classification, extent of recall into
distribution chain)
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Thank You
 Please feel free to contact me should you have any
questions
 jscohen@mwe.com
 202-756-8276
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