enforcement litigation and compliance washington, dc december 9-10, 2015 international enforcement...

Enforcement Litigation and Compliance

Washington, DC

December 9-10, 2015

International Enforcement and Compliance Initiatives

Jill Daley, Partner, Norton Rose Fulbright LLP

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 MedicinesThreat 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 20154

Manufactured Under Conditions Like These …

Copyright Pfizer 20155

Copyright Pfizer 20156

Copyright Pfizer 20157

…Rather Than These…

Copyright Pfizer 20158

+

+ +

Placing Emphasis on Appearance, Not Efficacy

Copyright Pfizer 20159

… And Containing …

Copyright Pfizer 2015

Wallboard

Brick dust

Commercial Paint Highway Paint

Pesticides

Chalk

NO API

WRONG API

INCORRECT DOSE OF API

10

… But Virtually Indistinguishable

Copyright Pfizer 201511

How Much of an Effort?

Copyright Pfizer 201512

Investment in Terms of Dollars

13Copyright Pfizer 2015

Pill Press

Seized in India

Seized in China

14Copyright Pfizer 2015

Size of a Double Garage

Raided in Colombia

15Copyright Pfizer 2015

Seized in Colombia

Air Compressor

16Copyright Pfizer 2015

Seized in Colombia

Blender

Grinder

Blender

Blender and Grinder

17Copyright Pfizer 2015

18Copyright Pfizer 2015

Pill Press Machines

19Copyright Pfizer 2015

Colombia CanadaChina

India

Pill Presses Seized in Different Countries

20Copyright Pfizer 2015

Pill Press Parts

21Copyright Pfizer 2015

Customs Inspections

Medicines and

Healthcare products

Regulatory Agency

22Copyright Pfizer 2015

Pakistan

India

Colombia

China

23Copyright Pfizer 2015

Egypt

Turkey

China

24Copyright Pfizer 2015

Tri Rotary or Single Punch

25Copyright Pfizer 2015

Sell Without Grandfather Papers

No Business License Number

No Tax Number

No Corporate Registration

26Copyright Pfizer 2015

Single Punch

27Copyright Pfizer 2015

Production Capabilities

Mine is a single punch…

…We can still make 50,000 tablets a month…

…and that’s by hand…

28Copyright Pfizer 2015

Arrested, Convicted and Deported

Surveillance photo of subject, Fernando Reis, taken at a meeting

with Pfizer undercover in Canada.

Arrested by RCMP

Convicted on counterfeit and steroid charges

Sentenced to 18 months in jail

Deported to the Azores upon release

Copyright Pfizer 2015 29

The Internet Threat

Copyright Pfizer 201534

“Canadian” Websites

35Copyright Pfizer 2015

Investigation triggered by seizure at London Heathrow Airport (May 2006)

“Canadian” Medicines

36Copyright Pfizer 2015

Death Linked to Online Medicines

Tainted with heavy

metals

Copyright Pfizer 201537

Copyright Pfizer 2015 43

FDA Enforcement against Imports

John Johnson IIISenior 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 Supply-chain

• 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 Lawsin 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 Lawsin 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 Lawsin Canada (cont.)

• Criminal sanctions for serious infringement of both trade-mark 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’sInspection 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 BanImplemented (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