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 0
38
Embed
Globalization and Its Impact on ORA and Regulated Industry · Globalization and Its Impact on ... 3. pharmaceutical necessities, ... Pharmaceutical product imports increased at nearly
This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
Transcript
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
0
TOPICS
GlobalizationWhat are we doing in response?
Medical Products InitiativesFDASIA
1
The Impact of
Globalization on FDA/ORA
Total Import Lines 2002-2013
22
3
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)
4
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)
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
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
• 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
3232
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
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
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
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