International Enforcement and
Compliance Initiatives
Jill Daley, Partner, Norton Rose Fulbright LLP
Enforcement
Litigation and
Compliance
Washington, DC
December 9-10, 2015
Brian Donnelly, Global Security, Director –
Americas Region, Pfizer, Inc.
John Johnson, Attorney, FDAImports.com, LLC
Michael Roosevelt, Deputy Director, Office of
Compliance, CFSAN
Moderated by Bob Rhoades, Senior Vice President,
Quality & Compliance Services, Quintiles
Counterfeit Medicines
Threat to Patient Health and Safety
Brian Donnelly
Director, Pfizer Global Security, Americas Region
December 2015
Copyright Pfizer 2015
What is a Counterfeit?
Pfizer defines a counterfeit medicine as any non-authentic Pfizer
tablet, capsule and/or packaging that appears the same as an
authentic Pfizer product.
A counterfeit may or may not contain the same active pharmaceutical
ingredient (API) as the authentic Pfizer medicine.
Lipitor, UK
Lipitor, US
Copyright Pfizer 2015
3
Threat to Patient Health and Safety
Copyright Pfizer 2015
4
Manufactured Under Conditions Like These …
Copyright Pfizer 2015
5
Copyright Pfizer 2015
6
Copyright Pfizer 2015
7
…Rather Than These…
Copyright Pfizer 2015
8
Placing Emphasis on Appearance, Not Efficacy
+
+
+
Copyright Pfizer 2015
9
… And Containing …
Wallboard
Brick dust
NO API
Commercial Paint
WRONG API
Pesticides
Highway Paint
INCORRECT DOSE OF API
Chalk
Copyright Pfizer 2015
10
… But Virtually Indistinguishable
Copyright Pfizer 2015
11
How Much of an Effort?
Copyright Pfizer 2015
12
Investment in Terms of Dollars
Copyright Pfizer 2015
13
Pill Press
Copyright Pfizer 2015
14
Size of a Double Garage
Raided in Colombia
Copyright Pfizer 2015
15
Air Compressor
Copyright Pfizer 2015
16
Blender and Grinder
Blender
Copyright Pfizer 2015
17
Copyright Pfizer 2015
18
Pill Press Machines
Copyright Pfizer 2015
19
Pill Presses Seized in Different Countries
Copyright Pfizer 2015
20
Pill Press Parts
Copyright Pfizer 2015
21
Customs Inspections
Medicines and
Healthcare products
Regulatory Agency
Copyright Pfizer 2015
22
Copyright Pfizer 2015
23
Copyright Pfizer 2015
24
Tri Rotary or Single Punch
Copyright Pfizer 2015
25
Sell Without Grandfather Papers
 No Business License Number
 No Tax Number
 No Corporate Registration
Copyright Pfizer 2015
26
Single Punch
Copyright Pfizer 2015
27
Production Capabilities
 Mine is a single punch…
 …We can still make 50,000
tablets a month…
 …and that’s by hand…
Copyright Pfizer 2015
28
Arrested, Convicted and Deported
 Arrested by RCMP
 Convicted on counterfeit
and steroid charges
 Sentenced to 18 months
in jail
Surveillance photo of subject, Fernando Reis, taken at a
meeting with Pfizer undercover in Canada.
 Deported to the Azores
upon release
Copyright Pfizer 2015
29
The Internet Threat
Copyright Pfizer 2015
34
“Canadian” Websites
Copyright Pfizer 2015
35
“Canadian” Medicines
Investigation triggered by seizure at London Heathrow Airport (May 2006)
Copyright Pfizer 2015
36
Death Linked to Online Medicines
Tainted with heavy
metals
Copyright Pfizer 2015
37
Copyright Pfizer 2015
43
FDA Enforcement against
Imports
John Johnson III
Senior Associate Attorney,
Benjamin L. England & Associates, LLC
& FDAImports.com, LLC
FDA Import Enforcement
Authority: Section 801(a)
The Secretary of the Treasury shall deliver to the Secretary of Health and Human Services, upon his request, samples of food, drugs,
devices, tobacco products, and cosmetics which are being imported or offered for import into the United States, giving notice thereof to
the owner or consignee, who may appear before the Secretary of Health and Human Services and have the right to introduce testimony.
The Secretary of Health and Human Services shall furnish to the Secretary of the Treasury a list of establishments registered pursuant
to subsection (i) of section 360 or section 387e(h) of this title and shall request that if any drugs, devices, or tobacco products
manufactured, prepared, propagated, compounded, or processed in an establishment not so registered are imported or offered for
import into the United States, samples of such drugs, devices, or tobacco products be delivered to the Secretary of Health and Human
Services, with notice of such delivery to the owner or consignee, who may appear before the Secretary of Health and Human Services
and have the right to introduce testimony. If it appears from the examination of such samples or otherwise that (1) such article has been
manufactured, processed, or packed under insanitary conditions or, in the case of a device, the methods used in, or the facilities or
controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of section 360j(f) of
this title, or (2) such article is forbidden or restricted in sale in the country in which it was produced or from which it was exported, or (3)
such article is adulterated, misbranded, or in violation of section 355 of this title, or prohibited from introduction or delivery for
introduction into interstate commerce under section 331(ll) of this title, or (4) the recordkeeping requirements under section 2223 of this
title (other than the requirements under subsection (f) of such section) have not been complied with regarding such article, then such
article shall be refused admission, except as provided in subsection (b) of this section. With respect to an article of food, if importation of
such food is subject to, but not compliant with, the requirement under subsection (q) that such food be accompanied by a certification or
other assurance that the food meets applicable requirements of this chapter, then such article shall be refused admission. If such article
is subject to a requirement under section 379aa or 379aa–1 of this title and if the Secretary has credible evidence or information
indicating that the responsible person (as defined in such section 379aa or 379aa–1 of this title) has not complied with a requirement of
such section 379aa or 379aa–1 of this title with respect to any such article, or has not allowed access to records described in such
section 379aa or 379aa–1 of this title, then such article shall be refused admission, except as provided in subsection (b) of this section.
The Secretary of the Treasury shall cause the destruction of any such article refused admission unless such article is exported, under
regulations prescribed by the Secretary of the Treasury, within ninety days of the date of notice of such refusal or within such additional
time as may be permitted pursuant to such regulations. Clause (2) of the third sentence of this paragraph 1 shall not be construed to
prohibit the admission of narcotic drugs the importation of which is permitted under the Controlled Substances Import and Export Act.
FDA Import Enforcement
Authority: Section 801(a) Summarized
• Examine any food, drug, cosmetic, device, or tobacco
product
• Refuse admission to any article that appears to violate
• Import alerts to ease enforcement
Imports as Part of the Supplychain
• Legal Requirements:
• Device: “Initial Importer” Registration
• Foods: Foreign-supplier Verification Program
• Drugs: FDASIA’s Standards for Imported Drugs
• Investigation:
• Produce Testing: avocados, cheese, hot peppers,
and cucumbers
Looking Domestically and
Abroad
• Facility inspections (Import Alerts 16-120, 66-41, 89-04)
• Epidemiological data (Import Alert 24-23 (cilantro))
Weakness of Current Approach
• Eli Lilly Case Study
• Eli Lilly’s Cialis from Australia on import alert
• But not manufactured in Australia, no plant even
in Austrilia
• Correct Manufacturer?
• Wrong facilities placed on import alerts due to
transmission errors
Canada – Counterfeiting, New
Regulations, and Initiatives
Jill Daley
Partner
Norton Rose Fulbright LLP
Presentation Overview
• Counterfeit Drugs and Health Products in
Canada
– Combatting Counterfeit Products Act
• Health Canada’s GMP Requirements
– Recent Transparency and Enforcement
Initiatives
– GMP Case Study: Apotex Import Ban and the
Federal Court
Counterfeit Drugs and Health
Products in Canada
• Presence of counterfeit products in Canada’s regulated
supply chair is rare
• Definition of a “Counterfeit Health Product”
– A counterfeit health product is one that is represented
as, and likely to be mistaken for, an authentic product.
• Counterfeit health products constitute a violation of the
Food and Drugs Act and relevant Regulations.
Counterfeit Drugs and Health
Products in Canada (cont.)
• Health Products and Food Branch Inspectorate
(“Inspectorate”) has the authority to take appropriate
enforcement measures against the manufacture,
importation, and sale of non-compliant health products,
including counterfeits.
– Inspectorate will immediately secure suspected counterfeit
health products to verify their compliance and inform the
appropriate law enforcement authorities (as the sale of
counterfeit goods is also a violation of the Criminal Code)
Counterfeit Drugs and Health
Products in Canada (cont.)
• “Diverted Products” not deemed counterfeit products –
these are genuine products that end up on a different
market than intended (theft, recalls, re-direction of
prescription drugs, etc.)
Anti-Counterfeiting Laws
in Canada
Combating Counterfeit Products Act (CCPA)
• Introduced in March 2013, re-introduced in October 2013
and received Royal Assent on December 9, 2014
• Border enforcement provisions of the CCPA in force on
January 1, 2015
• Prior to CCPA, Canada was criticized for lax counterfeit
and piracy enforcement
• CCPA affects provision under the Trade-marks Act,
Copyright Act and Criminal Code
Anti-Counterfeiting Laws
in Canada (cont.)
Remedies and Penalties
• Civil proceedings made available to trade-mark and
copyright owners to enforce rights
• Available remedies include damages, profits attributable
to the infringement, injunctions and surrender of the
counterfeit goods
Anti-Counterfeiting Laws
in Canada (cont.)
• Criminal sanctions for serious infringement of both trademark and copyrights under the Trade-marks Act and
Copyright Act
– Anyone who makes for sale or sells infringing copies of a work
– On summary conviction, a fine of up to $25,000 CAD or
imprisonment of up to 6 months, or both
– On indictment, a fine of up to $1 million CAD or imprisonment of
5 years, or both
Anti-Counterfeiting Laws Enforcement
The CCPA gives the Canadian Border Services Agency
(CBSA) customs officers the ability to detain goods that
may be counterfeit
• CCPA introduces the prohibitions under the Trade-marks
Act and Copyright Act of import or export of:
– Unauthorized goods or packaging bearing trade-marks identical
to or having all essential elements of a registered trade-mark
– Copies of works made without the consent of the owner of
copyright in the country where they were made
Anti-Counterfeiting Laws –
Enforcement (cont.)
• Trade-mark and copyright owners can file a “request for
assistance” (“RFA”) with the CBSA and provide
information on their IP to the CBSA
– CBSA can use the information provided as a basis to detain
goods at the border
– CBSA can also share certain information about suspect
shipments with rights holders
– Costs associated with detained shipment is the responsibility of
the rights holder
Health Canada – Good
Manufacturing Practices (GMP)
• All drugs made in Canada or abroad must meet high
safety and quality standards before being sold in Canada
• Legislative Requirements
– Division 1A, Part C of the Food and Drug Regulations defines
activities for which GMP compliance is to be demonstrated prior
to the issuance of a drug establishment licence
– Specific GMP requirements set out under Division 2, Part C of
the Food and Drug Regulations
Health Canada –
Good Manufacturing Practices
(GMP) (cont.)
• Health Canada Guidance Document: Good
Manufacturing Practices (GMP) Guidelines – 2009
Edition, Version 2 (GUI-0001)
– Provide interpretive guidance and facilitate compliance by the
regulated industry and enhance consistency in the application of
the regulatory requirements
GMP Inspection – Health Canada
Transparency
As part of the Transparency and Openness Framework
(launched in 2014), Health Canada ahs announced its
2015-2016 activities, which includes increased
enforcement
• Enhance inspection reporting for drugs, medical devices
and other health products – Health Canada will begin to
post previously-unavailable inspect information for drugs,
medical devices and other health products.
GMP Inspection – Health Canada
Transparency (cont.)
• Expand information in the Inspection Tracker
• Roll out annual reporting on compliance and
enforcement activities across Health Canada
GMP Inspection – Health Canada
Transparency (cont.)
In February 2015, Health Canada issued a Notice to
stakeholders (all current Drug Establishment Licence (DEL)
Holders and new DEL applicants) regarding the
responsibilities and obligations with respect to the Good
Manufacturing Practices and Health Canada’s ongoing
transparency initiatives.
GMP Inspection – Health Canada
Transparency (cont.)
• The purpose of the letter is to emphasize the
responsibilities and obligations of DEL holders and
compliance with GMP and current issues that are of
concern:
– For Active Pharmaceutical Ingredient (API) related activities
issues of traceability, supply chain integrity, vendor
qualifications, cleaning validation, data integrity, packaging
conditions were of concern
– Data integrity issues were noted in many establishments
domestically and globally
GMP Inspection – Health Canada
Transparency (cont.)
Health Canada recently launched a searchable database
including inspection results (the Drug and health Product
Inspections Database):
• Launched on April 13, 2015 under Health Canada’s
Regulatory Transparency and Openness Framework
• Contains information on drug inspections (foreign and
domestic) conducted by Health Canada since 2012
GMP Inspection – Health Canada
Transparency (cont.)
• Government of Canada (GC) licenses and regularly
inspects companies that make, package, test, import,
distribute and wholesale drugs
Inspection summary reports
• Accessible through the Inspections Database
• Provides chronological summary, including inpection
information on data integrity, cleaning, quality systems,
other systems and next steps
GMP Inspection – Health Canada
Transparency (cont.)
GMP Inspection – Health Canada
Transparency (cont.)
• Inspection Report includes:
– Background
– Corrective and preventive
actions taken
– Health Canada inspection
planning – main areas for
inspection
– Summary of Health Canada
inspections findings
– Re-assessment of
precautionary steps
– Actions/next steps
GMP Inspection – Health Canada
Transparency (cont.)
Inspection Tracker – Drug Manufacturing Establishments
• Health Canada is tracking potential health and safety
issues and publishes information regarding emerging
issues identified through our drub inspection program on
the Inspection Tracker
• Provides a snapshot of companies that fabricate,
package/label, sell, wholesale, distribute, import drugs
for sale in Canada.
GMP Inspection – Health Canada
Transparency (cont.)
• The Tracker highlights actions Health Canada is taking
such as requests for voluntary quarantine, stop sales,
import restrictions, or product recalls.
• The Tracker also indicates those circumstances where
no action has been warranted.
• Even if a company is listed on the Tracker, this does not
immediately mean there is a risk to Canadians – Health
Canada will investigate any risk to the health and safety
of Canadians
GMP – Health Canada’s
Inspection Tracker
When an item on the
Tracker is “closed”, this
indicates that there is no
further action being taken
by Health Canada at this
time.
Tracker is updated
frequently.
GMP Inspection – Health Canada
Enforcement
• Health Products and Food Branch Inspectorate
(“Inspectorate”) is responsible for managing the national
compliance and enforcement program for regulated
products under the Food and Drugs Act
• Inspectorate Policy “Compliance and Enforcement Policy
(POL-0001)”
GMP Inspection – Health Canada
Enforcement (cont.)
• Before any enforcement activity is undertaken, the
Inspectorate will consider the following factors in order to
determine the appropriate enforcement action to take:
–
–
–
–
–
–
–
Risk to health and safety
Compliance history of the manufacturer
Degree of cooperation of the manufacturer
Whether the manufacturer acted with indifference or pre-meditation
Likelihood the problem will reoccur
Likelihood of the enforcement action being effective
Inspectorate resources and priorities
GMP Inspection – Health Canada
Enforcement (cont.)
• If the manufacturer is unwilling or unable to comply, the
Inspectorate may then implement enforcement activities
including:
–
–
–
–
–
–
Customs activities
Injunctions
Prosecution
Forfeiture
Public warning or advisory
Letters to trade and regulated
parties
– Regulatory stop-sale
–
–
–
–
Search and seizure
Seizure and detention
Warning letter
Suspension or cancellation of
marketing authorization/product
licenses
– Refusal
– Suspension or amendment of
establishment license
Health Canada – Collaboration with
International Agencies
• Health Canada conducts inspections regularly within
Canada and globally and works closely with international
regulatory partners.
• International regulatory partners also perform
inspections in Canada.
• Data/notices/reports are shared with regulatory partners.
GMP Inspection Case Study:
Apotex Import Ban
• Health Canada learned of the serious problems at
Apotex’s Indian manufacturing plants in April 2014 when
US FDA inspectors found problems and announced
barring imports
• The US FDA inspection noted several significant
deviations from GMP standards, including
– Discarding unfavourable lab results
– Retesting samples until favourable results were achieved
– Practice of retesting without investigating the suspect product
sample
GMP Inspection Case Study:
Apotex Import Ban (cont.)
• On April 29, 2014 Health Canada sent Apotex a letter
asking them to cease sale of drug products or
ingredients coming from the Indian plants
• Apotex refused, stating there was no basis for ceasing
sale
• Subsequent US FDA warning letters/notices to Apotex
were forwarded to Health Canada
In the news …
• September 11, 2014, the
Toronto Star began
publishing a series of articles
regarding drug safety while
comparing the Minister and
Health Canada to its US
counterparts
• The articles resulted in
questioning of the Minister in
the House of Commons
Apotex Import Ban Implemented
• September 29, 2014, Health Canada allegedly learned of
“new information” from the FDA that formed the basis of
their decision to implement the import ban
• September 30, 2014, Health Canada banned the
importation of drugs from two of Apotex’s manufacturing
facilities in India: Apotex Pharmachem India Pvt. Ltd.
(APIPL) and Apotex Research Private Limited (ARPL)
– The Minister instructed Canadian Border Services Agency to
immediately restrict importation of drugs from APIPL and ARPL
Apotex Import Ban
Implemented (cont.)
• October 2, 2014, Apotex’s Establishment Licenses
amended by Health Canada to prohibit all imports,
except those that were deemed “medically necessary”
• October 29, 2014, Apotex commenced judicial review of
Health Canada’s decision to implement the import ban
Apotex Import Ban –
Judicial Review Application
• On October 29, 2014, Apotex commenced an application
for Judicial Review of Health Canada’s decision to
implement the import ban on these three points:
– the Minister acted unreasonably and unlawfully in her decision to
implement the import ban;
– the Minister failed to act in accordance with the principles of
natural justice; and
– the Minister acted outside of her regulatory powers conferred
under the relevant legislation.
Apotex Import Ban –
Federal Court Decision
• Justice Manson of the Federal Court quashed the import
ban against APIPL and ARPL and ordered health
Canada to retract the public statements that were made
in connection with the import ban.
Apotex Import Ban –
Federal Court Decision (cont.)
• The Court concluded:
– The import ban was motivated by an improper purpose (media
and political pressure).
– Apotex was not afforded the procedural protections required by
law (reasonable notice before implementing the ban and the
opportunity to be heart).
– Health Canada and the Minister acted without jurisdiction in
releasing public statements to the media.
Apotex Import Ban –
Health Canada Statement
On November 2, 2015, following the Federal Court’s
decision, Health Canada released the following statement:
“On September 30, 2014, Health Canada published an Information Update
and the Minister of Health issued a statement regarding a decision that had
been made to restrict the importation of products from the following two
Apotex facilities in India: Apotex Pharmachem India Pvt. Ltd. (APIPL) and
Apotex Research Private Limited (ARPL).
On October 14, 2015, the Federal Court issued a judgment quashing the
September 30, 2014 decision based on Health Canada and the Minister
having proceeded unfairly and having acted for an improper purpose.
In accordance with the Court's judgment, Health Canada hereby retracts its
Information Update and the Minister retracts her statement, both dated
September 30, 2014.”
FDA Activities Overseas
Michael Roosevelt, Deputy Director
Center for Food Safety and Applied Nutrition
- Office of Compliance
December 9, 2015