Globalization and Its Impact on

ORA and Regulated Industry

Mutahar Shamsi

Acting Regional Food and Drug Director

Northeast Region, FDA

2013 RAPS: The Regulatory Convergence

Global FDA Compliance Update

October 1, 2013 December 9, 2013

Boston Waltham, Massachusetts

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TOPICS

GlobalizationWhat are we doing in response?

Medical Products InitiativesFDASIA

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The Impact of

Globalization on FDA/ORA

Total Import Lines 2002-2013

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FY 12 Import Data

Nationwide Total: 29,492,157 lines

• NER: 5,123,709 (about 17% of all US lines)

• NWE-DO: 558,077 (ranks 10th of all districts; about 2% of all US lines)

• NYK-DO: 4,565,632 (ranks 2nd of all districts; about 15% of all US lines)

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FY 13 Import Data

Nationwide Total: 32,646,214 lines

• NER: 5,333,087 (16% of all US lines)

• NWE-DO: 563,655 (ranks 11th of all districts; about 2% of all US lines)

• NYK-DO: 4,769,432 (ranks 2nd of all districts; about 15% of all US lines)

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Import Data

Regulated Area

• NWE-DO

• Human Foods: 55%

• Devices: 30%

• Animal Foods:4%

• Drugs: 1.5%

• NYK-DO

• Human Foods: 49%

• Cosmetics: 24%

• Devices: 11%

• Drugs: 2%

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Import Data

Product

• Devices

• NWE-DO

1. Laparoscope

2. patient physiological monitor

3. percutaneous catheter

• NYK-DO

1. unscented menstrual pads

2. sunglasses

3. corrective shoe orthosis

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Import Data

Product

• Drugs

• NWE-DO

1. relaxant, N.E.C.

2. pharmaceutical necessities & containers

3. pharmaceutical necessities, N.E.C.

• NYK-DO

1. ultraviolet screen, N.E.C.

2. triclosan (disinfectant)

3. oxybenzone (UV screen)

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Import Data

Product

• Biologics

• NWE-DO

1.biological in-vivo & in-vitro diagnostics, N.E.C.

2.in-vitro diag products, N.E.C.

3.human serum

• NYK-DO

1.biological in-vivo & in-vitro diagnostics, N.E.C.

2.in-vitro diag products, N.E.C.

3. peripheral blood stem cells

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Import Data

Import Alerts

NWE-DO: 36

NYK-DO: 210

NER: 246

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Import Data

Import AlertsNWE-DO:

CDER products: 3

• unapproved new drug (IA 66-41)

CDRH products: 9

• gloves – holes/defects (IA 80-04)

• electrical muscle stimulators/iontophoresis devices

(IA 89-01)

• lacks 510(k) or PMA (IA 89-08)

• laser products not meeting performance standard

(IA 95-04)

CBER products: 0 (zero)

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Import Data

Import AlertsNYK-DO:

CDER products: 31

• unapproved new drug (IA 66-41)

• micro contamination of drugs (IA 55-05)

CDRH products: 6

• gloves – holes/defects (IA 80-04)

• lacks 510(k) or PMA (IA 89-08)

• surgical instruments from Pakistan (IA 76-01)

CBER products: 0 (zero)

Import Data

NWE-DO

44%

15%

5%

Import Data

NYK

35%

8%

8%

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Import Data

Ports of Entry

• NWE-DO

• Logan Airport

• Houlton ME

• Conley Terminal

• NYK-DO

• Buffalo/Niagara Falls

• Newark NJ

• Champlain/Rouses PT.

Globalization - Trends

32 million shipments arrive at over 300 U.S. ports of entry annually

FDA-regulated products originate from more than 150 countries 130,000 importers

300,000 foreign facilities

Growth is expected to continue

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Globalization - Production

Food ~15% of all food consumed by U.S. households is imported

Approximately 50% of fresh fruits and 20% of fresh vegetables are imported

80% of seafood eaten domestically come from outside the United States

Food imports have increased an average of 10% per year from 2005-2011

Devices At least 35% of all medical devices used in the United States are

imported

Medical device imports have grown at over 10% per year from 2005-2011

Drugs 80% of API manufacturers are located outside the United States

40% of finished drugs are manufactured abroad

Pharmaceutical product imports increased at nearly 13% per year from 2005-2011 16

Globalization - Challenges

Increased number of “facilities” - individuals, producers, and companies - geographically dispersed worldwide importing regulated products into the U.S. at increasing volumes

Complex supply chains for given product; more complex manufacturing processes

Growing availability of distribution channels for products (e.g., Internet, couriers)

Facilitated by better product mobility as a result of improvements in transportation

Increased potential to encounter Intentional adulteration & counterfeiting for economic or other reasons 17

GLOBILIZATION

What Have We / Are We Doing In

Response?

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Moving FDA Towards a Global

Operations Paradigm http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Rep

orts/UCM298578.pdf

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“Over the next decade, FDA will continue to

transform from a predominantly domestically

focused Agency, operating in a globalized

economy, to an Agency fully prepared for a

regulatory environment in which FDA products

know no borders.”

-- FDA Global Engagement Report

April 2012

2020

Global Building Blocks• Enhanced import risk management/targeting tools

– PREDICT

• Increase in foreign inspections overseas & creation of dedicated

foreign inspection cadres

– Drug, Food, Devices

• Establishment of foreign offices

– Relationship building with CAs, information gathering/sharing,

technical assistance, assistance with in-country emergency

response, inspections

• Comparability/equivalence determinations

• International agreements & multilateral activities including

harmonization efforts

– Promotes information sharing, work sharing

– Codex, PIC/S, Medical Device Single Audit

• Capacity building through leveraging with donor organizations 2121

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Increase in Foreign Inspections

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FDA Foreign Offices

HeadquartersSilver Spring, MD

Mexico City

San Jose

Santiago

Amman

London

Parma

Brussels

Pretoria

New Delhi

Mumbai

Beijing

Shanghai

Guangzhou

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Organizational Changes to Support

Shifts to Address Globalization

Office of the Commissioner Reorganization

Directorates

− Office of Operations

− Office of Foods

− Office of Medical Products and Tobacco

− Office of Global Regulatory Operations and Policy

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Office of Global Regulatory

Operations and Policy (GO)

Components of Office of Global Regulatory

Operations and Policy (GO) Office of Regulatory Affairs

Office of International Programs

GO Directorate Mandate Make FDA’s response to globalization challenges and import safety a top

priority in years to come

Ensure that FDA fully integrates its domestic and international programs to

best promote and protect public health

Implement “Pathway to Global Product Safety and Quality”

Ensures that FDA integrates its domestic and international programs

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http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsan

dPolicy/GlobalProductPathway/UCM262528.pdf29

Four Pillars to New Strategy

• Partner with foreign counterparts to create global coalitions of regulators focused on ensuring and improving global product safety.

• Work with these coalitions to build a global data-information system and network and proactively share data with peers.

• Expand capabilities in intelligence gathering and use, with an increased focus on risk analytics and thoroughly modernized IT capabilities.

• Allocate agency resources effectively based on risk, leveraging the combined efforts of government, industry and public and private third parties. 30

Summary

Product safety and quality no longer begin or end at

the border

Shift to a public health regulatory agency fully

prepared for a complex, globalized regulatory

environment

Requires a strong, multifaceted strategic solution

Together, we’ll build a public health safety net for a

globalized economy31

Food and Drug Administration Safety and Innovation Act (FDASIA)

Effect on ORA

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Overview

President Obama signed FDASIA legislation on July 9, 2012

Provides for reauthorization of the following:

– Medical Device User Fee Act

– Prescription Drug User Fee Act

Establishes user fees for generic drugs and biosimilars.

The generic drug user fee amendment provisions in FDASIA

will have a major impact on ORA

Grants FDA the authority to review applications more expeditiously

Reauthorizes FDA’s authority to compel companies to conduct

pediatric clinical trials

Takes measures to end drug shortages

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What is the Generic Drug User Fee Amendment (GDUFA)?

GDUFA is an agreement between FDA and regulated industry to provide additional resources to the Agency, which will speed the review of generic drug applications.

During the five-year period from fiscal year 2013 through 2017, the generic drug industry will provide FDA an inflation-adjusted $299 million each year in user fees, supplementing the Agency’s allotted budget for assessing the safety of generic drugs.

By reducing the time it takes to determine whether a particular generic drug can be marketed in the United States, GDUFA will improve patient health and reduce uncertainty for industry

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Consumers and Industry

GDUFA will impose user fees on several areas:

– Applications that are pending as of October 1, 2012 at the FDA

– New applications coming in on or after October 1, 2012

– Drug master files

– Facilities – both domestic and foreign – involved in the manufacture of generic drugs

Companies involved in these areas will be required to pay fees

GDUFA is not expected to add more than $0.10 to the cost of a generic drug prescription.

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ORA Effect

• GDUFA• Increase number of inspections

• Hiring 80 new Investigators nationwide

• Drug Shortages• Enforcement actions

• Drug Supply Chain• Risk based inspection model

• Medical Device Improvements• Proactive information on recalls

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QUESTIONS?

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