Keynote Address: Practical Case Considerations and ... · PDF fileKeynote Address: Practical Case Considerations and Interactions with Your Local FDA Compliance Branch –Yesterday,

Keynote Address: Practical Case

Considerations and Interactions with Your

Local FDA Compliance Branch – Yesterday,

Today and Tomorrow

IVT’s 22nd Annual Validation Week

Coronado Island, CA [Oct. 18-20, 2016]

Dr. Raymond W. Brullo, DPM

FDA Compliance Officer/Investigator

Doctor of Podiatric Medicine

FDA Los Angeles District Office, Irvine, CA

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Disclaimer

The following slides and presentation by

me, Dr. Raymond W. Brullo, are my own

views. There is no implication that they are

the views of the Agency/FDA.

Quoting of my presentation, in whole or in

part in any format [e.g. social media or

other media not included in the provisions

of the sponsor brochure], is prohibited.

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Keynote Address – Defined @

Merriam Webster

An address designed to present the

issues of primary interest to an

assembly (as a political convention)

and often to arouse unity and

enthusiasm —called also keynote

speech

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Agenda/Objectives

Part 1: a sampling of regulatory and enforcement actions & how to respond to the District and Compliance Officer – some logistics

Part 2: public accessible documents –what’s been said and occurred [2004-present] & the regulatory continuum – past, present, and future – reality and projections

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Brullo presentation to ASQ, August 2012

Warning Letter to Albert Browne Ltd., Leicester,

UK [29-May-12]

These violations include, but are not limited to, the

following:1. Failure to establish and maintain

adequate procedures for validating the device

design, as required by 21 CFR 820.30(g). For

example, acceptance criteria were not established

prior to the performance of validation activities

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Brullo presentation to ASQ, August 2012

Civil Money Penalties

FDA reached $1 million settlement with

Pennsylvania medical device firm

Firm had marketed its device without the

proper premarket approval or clearance

$550,000 penalty to the firm with $450,000

penalty to the firm’s CEO

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People, Time and Money

Need All Three to Correct and Prevent

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What should you do if you get a

regulatory action?

Top Management must be advised

Act promptly… this could be the start, not

the end, and escalate to enforcement action

Respond as completely as possible, usually

to the Director, LOSDO Compliance

Branch. Caveat: in practical terms, the case

will be linked to a local Compliance Officer

who will be the reviewer and point person.

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Requesting a Meeting with the District

Office

A meeting is usually, but not always, requested by

a firm to provide an overview of the company’s

commitment and progress [corrective actions,

management perspective]

Typically there is a PowerPoint presentation and

colorful handouts. The District is under no

obligation to agree to such a meeting

Benefit: to show “good faith” and present a “face”

to the District

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When a Meeting is a Regulatory Meeting (e.g.

“reg meeting”) (Prior Notice)

Anything can be discussed including past history,

current deficiencies, and violations so be prepared

with documented evidence of corrective actions.

Be prepared to provide a timetable for next steps

and specific commitments towards realistic

corrective and preventive actions.

Post-reg meeting, stay in touch with the CO and

provide clear, organized responses

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Los Angeles District Office – Compliance

Branch – Connections…Current

District Director

Investigations Branch Director

Investigators

Consumer Complaints

Compliance Branch Director

Compliance Officers

Recalls

Director, Pacific Regional Laboratory

Southwest

Directors, Microbiology Branch Chemistry

Branch

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How to Interact with the Local Compliance

Branch and Officer (Correspondence)

Typically, written correspondence, perhaps with

disk, via overnight carrier

Hand-delivery: firm may try to solicit a quick

“meeting” and also serves as “good faith” and

assurance of delivery to District

Email: it can be printed off and then uploaded to

specific FDA databases. But, if it has large e-files,

written correspondence is preferred or provided

additionally

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Branch and Officer

Do tab responses so that included evidence is

clearly marked and referenced in the general

narrative of the response. Do provide a table of

projected corrective actions and anticipated dates

of completion

Telephone call(s) if indicated - limit

Don’t circumvent the CO via the Investigator,

Director of Compliance, or other management as

the CO is following the case day-to-day

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Branch and Officer

Do not rely on requests for response

extensions, especially to the FDA-483

Be careful when having a consultant or

attorney speak for you. You are still

responsible; particularly, at the follow-up

inspection

Enforcement: let your attorney and FDA,

DOJ attorneys work things out

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Part 2: Regulatory: Past, Present, Future

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FDLI Litigators Conference 2005 –

Enforcement Policy

Cooperative and educational efforts

Fair, risk-based, scientifically sound principles to assure efficient enforcement

Risk-based approaches to inspection, compliance, and enforcement activities using available enforcement tools commensurate with

violations, or

relying on voluntary action as appropriate

Punish violations of fraud, gross negligence, or intentional violations and deter others through action

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Enforcement Policy

Collaborate and cooperate with federal,

state, local, foreign governments,

international organizations

Evaluate and improve programs

Assure quality in all work products while

meeting productivity expectations

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Enforcement

Risk management principles

Assess the Violations

Analyze the Violations

Consider the Desired Outcome

Optimize the Compliance or Enforcement Decision

Pursue the Decision with Vigor

Use enforcement resources wisely to achieve effective and efficient compliance

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FDLI Litigators Conference 2005 – What

Can Industry Do?

Continue to innovate and develop products

that advance public health

Demonstrate a corporate philosophy of

compliance

Pay attention to signals

Be forthright and proactive

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FDA Inspection Summit, October 2008

Increase in Numbers of Recalls 4,804 recalls (FY2008) vs. 3,625 recalls (FY1997)

Decrease in Consumer Confidence

April 2007 Harris Interactive Survey

Various Outbreaks or Safety Warnings

Significant Attrition within FDA

New Initiatives and Legislation

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FDA Inspection Summit, October 2008 –

What Should be Counted as a Compliance

Action?

Recalls (State & FDA) Emergency Permits

Regulatory Meetings Guidance Documents

Certain Press Releases Import Actions

FR Notices Education/Outreach

“Untitled” Letters FDA 483s

Inspections State Actions

Voluntary actions

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Commissioner…2009 speech to

Food and Drug Law Institute

“…in order to have an effective

enforcement strategy that protects the public

health, “the agency must be able to respond

rapidly to egregious violations or violations

that jeopardize the public health.” The

Commissioner hoped that “in the future,

effective FDA enforcement actions will not

be surprising…or out of the ordinary.”

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June 2009 Commissioner launched the

FDA Transparency Initiative

In January, 2010, as part of phase I of the

Transparency Initiative, FDA launched a

web-based resource, FDA Basics

(www.fda.gov/fdabasics), to provide basic

explanations about FDA’s work

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http://www.fda.gov/fdabasics

Device Trends and Challenges, 2010

Implement total life-cycle review

and comprehensive 510(k) review

Increased post market surveillance

program

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ORA, Chief Counsel, and Center compliance

offices joint statement…July 15, 2010

“All FDA components are

committed to swift, aggressive

enforcement actions to protect

the public health.”

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MDIC Strategy: Create a Public-Private

Partnership between Industry, FDA and Non-

profits (2012 and 2016)

Align Resources: Working cooperatively with

FDA to re-engineer pre-competitive technology

innovation

Accelerate Progress: Reducing the time and

resources needed for new technology

development, assessment, and review

Achieve Results: Helping patients benefit by

gaining access to new medical technologies sooner

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2012/2013 LOSDO and Orange County DA’s Office

Unapproved medical device – hair growth

laser/low level red lights

LOSCB Warning Letter for lack of 510(k) and

cGMPs. FDA seizure action not supported as

State of CA had embargo in place

2015-2016: Although firm obtained a 510(k),

Orange Country DA developed case resulting in

consent decree and monetary penalties

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Reviewing FDA’s Implementation of

FDASIA, November 15, 2013

Final rule for a Unique Device Identification

(UDI) System

Re-issue of a draft IDE guidance

Streamlining of the de novo pathway

Stakeholder input re modification to a 510(k)-

cleared device

Class III Preamendment Devices – process change

Humanitarian Device Exemption – modified

provision29

FDANews Inspections Summit

October 24, 2014

Program Alignment Initiative – functional and

operational change – optimize coordination;

strengthen accountability; reduce duplication

Increased technical expertise; work with subject

matter experts in Centers

Risk-based inspection approach with metrics

Case for Quality: quality; data; stakeholders

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International Medical Device Regulatory

Forum - Medical Device Single Audit

Program, 2014

Global approach to auditing and monitoring

the manufacturing of medical devices

Provides confidence in program outcomes

Third Parties and Regulatory Inspectorates

Oversight of Regulatory Authorities

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International Programs, @fda.gov, 2016

CDRH commitment to assuring patients and

providers have timely and continued access to

safe, effective and high-quality medical devices

CDRH engages with foreign medical authorities

CDRH exchanges information through web-based

training, scientific and policy discussions and

confidentiality commitments

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FDA Program Alignment Medical Devices

and Radiological Health FY2016 Action Plan

Transition to Commodity-Based and Vertically

Integrated Regulatory Program (Specialization)

Training and Certification

Medical Devices and Radiological Health

Program Work Planning

Quality Policy and Strategy

Imports

Laboratory Optimization

IT33

Medtech Insight – September, 2016

Park Prosecutions Are Expected To Continue

2015 memo from US Deputy Attorney General

Misdemeanor convictions of two former execs at

J&J unit

Thorough internal review and policies/procedures

that ensure transparency

Senior management can show they tried to avoid

violations

Schedule opportunities to present concerns to

management

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CDRH: Narrative by Activity, @ 2016-2017

Priorities are to: Establish a National Evaluation

System for Medical Devices; Partner with

Patients; Promote a Culture of Quality and

Organizational Excellence

Improve and streamline access

Guidances

Product Approvals

Clinical Trial Enterprise

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Early Feasibility Studies

Expedited Access Program

Patient Preference Initiative

Patient Engagement Advisory Committee

Medical Device Innovation Consortium

Next Generation Sequencing

Experiential Learning Program

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CDRH Learn

Customer Service

Enhance Oversight

Medical Device Reporting

Medical Product Safety Network

National Medical Device Evaluation System

Unique Device Identification

Registry Based Surveillance

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Signal Management Program

Case for Quality Initiative

Voluntary Compliance Improvement Pilot

Program

Medical Device Single Audit Program

Digital Health Program

Radiological Health Program

Mammography Quality Standards Act Program

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CDRH: Case for Quality

(@www.fda.gov, 2016)

Focus on Quality

Enhance Data Transparency

Stakeholder Engagement

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2016-2017 Strategic Priorities

Center for Devices and Radiological Health

Establish a National Evaluation System for

Medical Devices

Partner with Patients

Promote a Culture of Quality and

Organizational Excellence

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2016-2017 Strategic Priorities

Center for Devices and Radiological Health

http://www.fda.gov/downloads/AboutF

DA/CentersOffices/OfficeofMedicalPr

oductsandTobacco/CDRH/CDRHVisio

nandMission/UCM481588.pdf

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Bonus Reminder! CDRH Learn!

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Bonus Reminder! Medical Device

Webinars and Stakeholder Calls!

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Dr. Raymond W. BrulloCompliance OfficerDoctor of Podiatric MedicineLos Angeles District [email protected]

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mailto:[email protected]