Globalization and Its Impact on ORA and Regulated Industry

Transcription

1 Globalization and Its Impact on ORA and Regulated Industry 2013 RAPS: The Regulatory Convergence Global FDA Compliance Update October 1, 2013 December 9, 2013 Boston Waltham, Massachusetts Mutahar Shamsi Acting Regional Food and Drug Director Northeast Region, FDA 0

2 TOPICS Globalization What are we doing in response? Medical Products Initiatives FDASIA 1

3 The Impact of Globalization on FDA/ORA Total Import Lines

4 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 10 th of all districts; about 2% of all US lines) NYK-DO: 4,565,632 (ranks 2 nd of all districts; about 15% of all US lines) 3

5 FY 13 Import Data Nationwide Total: 32,646,214 lines NER: 5,333,087 (16% of all US lines) NWE-DO: 563,655 (ranks 11 th of all districts; about 2% of all US lines) NYK-DO: 4,769,432 (ranks 2 nd of all districts; about 15% of all US lines) 4

6 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% 5

7 Product Import Data Devices NWE-DO 1. Laparoscope 2. patient physiological monitor 3. percutaneous catheter NYK-DO 1. unscented menstrual pads 2. sunglasses 3. corrective shoe orthosis 6

8 Product Import Data 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) 7

9 Product Import Data 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 8

10 Import Alerts Import Data NWE-DO: 36 NYK-DO: 210 NER: 246 9

11 Import Data Import Alerts NWE-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) 10

12 Import Data Import Alerts NYK-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) 11

13 Import Data NWE-DO 44% 15% 5%

14 Import Data NYK 35% 8% 8%

15 Import Data Ports of Entry NWE-DO Logan Airport Houlton ME Conley Terminal NYK-DO Buffalo/Niagara Falls Newark NJ Champlain/Rouses PT. 14

16 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 15

17 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 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 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

18 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

19 GLOBILIZATION What Have We / Are We Doing In Response? 18

20 Moving FDA Towards a Global Operations Paradigm orts/ucm pdf 19

21 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

22 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 21

23 Increase in Foreign Inspections 22

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27 FDA Foreign Offices London Brussels Mexico City Headquarters Silver Spring, MD Parma Amman New Delhi Beijing Guangzhou Shanghai Mumbai San Jose Pretoria Santiago 26

28 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 27

29 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 28

30 dpolicy/globalproductpathway/ucm pdf 29

31 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 datainformation 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

32 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 economy 31

33 Food and Drug Administration Safety and Innovation Act (FDASIA) Effect on ORA 32

34 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 33

35 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 34

36 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. 35

37 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 36

38 QUESTIONS? 37