The Blue Mountain Summit 2012 Top FDA Enforcement Trends What You Need to Know about FDA’s Latest Priorities and Initiatives By: Martin Browning, EduQuest,

The Blue Mountain Summit2012

Top FDA Enforcement TrendsWhat You Need to Know about FDA’s Latest Priorities and Initiatives

By: Martin Browning, EduQuest, Inc.www.EduQuest.net

Martin BrowningPresident & Founder

• EduQuest, Inc.

• 22 years with U.S. FDA

• Special Assistant to Associate Commissioner of Regulatory Affairs

• Co-Author of 21 CFR Part 11

• Former chair of U.S. ISO 9000 committee; served on GHTF

• Helped to develop all FDA regulations dealing with computerized systems

• Chair of EduQuest live training courses (www.EduQuest.net)

© 2012 EduQuest, Inc. 2

http://www.EduQuest.net/


Top FDA Enforcement TrendsWhat You Need to Know about FDA’s Latest Priorities and

Initiatives

Agenda• Introduction to FDA’s Goals 2012– 2015 • Issues and Approaches• Focus on impact to Manufacturers• Evolving pressures and what to expect• Summary• Questions

Introduction to FDA’s Goals 2012– 2015

• Advance Regulatory Science and Innovation• Strengthen the Safety and Integrity of the Global Supply

Chain• Strengthen Compliance and Enforcement Activities to

Support Public Health• Expand Efforts to Meet the Needs of Special

Populations• Advance Medical Countermeasures and Emergency

Preparedness


Goal 1: Advance Regulatory Science and Innovation

• Promote the public health by fostering innovative approaches and solutions on behalf of some of the most compelling health and medical changes

• Participate more actively in the science research enterprise directed towards new treatments and interventions


Goal 1: Advance Regulatory Science and Innovation

• Modernize the evaluation and approval processes• Over the next five years, FDA will create and

implement a strategic plan for expanding and modernizing the field of regulatory science within the agency.


Goal 2: Strengthen the Safety and Integrity of the Global Supply Chain

• The border must be viewed as a final checkpoint for preventive controls, rather than the primary line of defense against unsafe imports.

• FDA must require more (and better) information about product supply chains and monitor this information throughout the product life cycle

• Regulatory standards must foster corporate responsibility to identify, protect, and control risks


Goal 2: Strengthen the Safety and Integrity of the Global Supply Chain

• Updated compliance and enforcement tools, a greater global safety net that includes a global alliance of regulators,

• Coordination of activities with international capacity-building and standards-setting organizations, adequate funding to allow for inspections, examinations and sample collections and analysis, and updated systems, including IT support, to assist with the increased workload.


Challenges Presented by Globalization

• Increasing volume of imported products• Greater complexity in imported products• More foreign facilities supplying the United States• Incomplete regulatory information about supply chains• Patch work of foreign, federal, and state oversight of

product safety• Greater opportunities for economic adulteration and

intentional fraud


Challenges Presented by Globalization

• National security threats• Enforcement tools that do not reflect today’s

commercial practices• Corporations lacking accountability• Current import regulatory system, an honor system

10© 2012 EduQuest, Inc.

Goal 3: Strengthen Compliance and Enforcement Activities to Support Public Health

• The agency established deadlines for industry to respond to significant inspection findings, which enable FDA to take enforcement action more rapidly if a manufacturer has not corrected violations documented after an inspection.

• FDA has implemented processes to prioritize follow-up inspections after the agency has issued a Warning Letter, classified a major recall, or taken other significant enforcement and compliance actions.


Goal 3: Strengthen Compliance and Enforcement Activities to Support Public Health

• Continued use of FDA’s criminal enforcement program which uses stringent sanctions, including prison sentences, fines, restitution and forfeiture to deter conduct that violates FDA-enforced laws.


Goal 4: Expand Efforts to Meet the Needs of Special Populations

• Children• Women’s health• Minority health• Obesity


Goal 5: Advance Medical Countermeasures and Emergency Preparedness

• FDA has developed a Medical Counter Measures Action Plan with 3 pillars:– Enhancing the Regulatory Review Processes for MCM

establishing multidisciplinary Public Health and Security Action Teams to build consistent regulatory approaches and efficient implementation of best regulatory review practices


Goal 5: Advance Medical Countermeasures and Emergency Preparedness

• FDA has developed a Medical Counter Measures Action Plan with 3 pillars:– Advancing Regulatory Science for MCM Development and

Evaluation through internal and collaborative research, as well as through partnerships with academia, federal government agencies and industry

– Optimizing the Legal, Regulatory and Policy Framework for Effective Public Health Response through review of the strengths and weaknesses of existing legal and policy approaches to MCM


Strategic Goals and Long-Term Objectives

• Advance Food Safety and Nutrition– Ensure the Safety of the Food Supply from Farm to

Table

• Promote Public Health by Advancing the Safety and Effectiveness of Medical Products– Advance Human Drug Safety and Effectiveness

• Availability, quality, integrity, and safe use



– Advance Biologics Safety and Effectiveness• Address bioterrorism, pandemic and emerging infectious

diseases• Foster international collaboration• Facilitate development of safe and effective biological products

– Advance Medical Device Safety and Effectiveness• Fully implement a total product life cycle approach that enables

well-supported regulatory decisions at any stage of a device’s cycle

• Proactively facilitate innovation and address unmet public health need



• Establish an Effective Tobacco Regulation, Prevention, and Control Program

• Manage for Organizational Excellence and Accountability



• Signature Initiative: SCIENTIFIC COMPUTING INITIATIVE

• Signature Initiative: ANALYTICAL TOOLS INITIATIVE

• Signature Initiative: SCIENTIFIC INNOVATION FOR RARE DISEASE THERAPIES

• Signature Initiative: QUALITY SYSTEMS FOR THE HUMAN DRUGS PROGRAM

• Signature Initiative: STEM CELL INITIATIVE


Significant Issues – Human Drugs

• Promote public health by ensuring the availability of safe and effective new drugs– Identify and develop new scientific methods, models, and

tools to improve the quality, safety, predictability, and efficiency of new drug development

– Conduct rigorous science-based premarket review to ensure that drugs that will be marketed to the public are safe and effective

– Ensure patient awareness of drug benefits and risks through effective communication of drug information



• Protect public health by ensuring the quality and integrity of marketed drug products– Secure the global supply chain to ensure that drugs are being

manufactured and distributed to conform to established quality standards

– Improve drug quality oversight capacity through expanded use of risk-based methods

– Ensure public awareness of drug quality and integrity issues through effective consumer communications



• Protect public health by promoting the safe use of marketed drugs– Conduct postmarket surveillance to ensure early detection of

new safety signals – Conduct rigorous studies to understand new drug safety

signals and effectively manage emerging risks– Ensure patient and health professional awareness of drug risks

and parameters for safe use– Oversee drug promotion and marketing – truthful and not

misleading


Signature Initiative: Human Drugs

• The Human Drugs Program is designing a quality systems framework– To enhance regulatory review and cross-cut business

processes in support of consistent, scientifically sound, high-quality work products.

– To enable a culture of continual process review and improvement, with performance measures that focus attention on how to best accomplish the program’s mission.


Signature Initiative: Human Drugs

• The Human Drugs Program is designing a quality systems framework– To design a set of strategic objectives designed to ensure that

the program has the correct set of expertise, strong management, integrated supporting infrastructure, and clear lines of communication to support rigorous, well-informed decision-making.


Emerging Issues

• Oversight of Compounding Pharmacies– In 2000 FDA was “unaware” of any “hospital compounding

pharmacies” shipping in Interstate Commerce– In 2012 there are over 3000 – none actively regulated by FDA– Current Issue – fungus in steroid injections “compounded in

as IS hospital pharmacy


Emerging Issues

• Top 10 Health Technology Hazards For 2012 Includes 4 issues directly traceable to software. All 4 of these involve application/user interface issues.

• Re-emergence of 21 CFR Part 11 and the issuance of EU’s Annex 11– More clear– Specific requirements– Formalizes risk processes much more than FDA regulations

and guidance


Summary

• Increased focus on supplier management• Heightened manufacturer oversight (inspections)• Better local and national coordination of inspection

strategy• More international inspections• Overall review of pre-market processes• Expect adverse event reports, complaints, recalls,

advertising to attract more attention


Summary

• Tightened timeframes• More Warning Letters• More high-profile cases should be expected• More “corporate initiatives” (coordinated inspections at

multiple sites)• Movement toward a more “professional approach” to

inspections.• Fewer “bites at the apple” before serious action


Summary

• Emphasis on risk (patient, product, process – not the risk of getting caught

• Remember our documentation is generally of poor quality, we have lost documents, lost design records, and failed to record decisions and justifications

• Recalls are increasing – quality is decreasing• Be wary of history, FDA is evolving



Q U E S T I O N S ?

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Documents

The Blue Mountain Summit 2012 Top FDA Enforcement Trends What You Need to Know about FDA’s Latest Priorities and Initiatives By: Martin Browning, EduQuest,