Enforcement Litigation and Compliance

Washington, DC

December 9-10, 2015

Enforcement Basics: What to do When the Government Shows Up at Your Door

Gary Bird, President, PharmaConsult-US

Lori Hirsch, Managing Counsel, Merck & Co., Inc.

LCDR Collins Mason, Director, Compliance Branch, Baltimore District, FDA

Amra Racic, Principal Regulatory Affairs Policy and Advocacy Specialist, Medtronic PLC

Moderated by Nancy Singer, President, Compliance-Alliance, LLC

Enforcement Basics: What to do when the government

shows up at your door.

Panelists:   Gary Bird, PharmaConsult-US

Lori Hirsch, Merck & Co., Inc. LCDR Collins Mason, FDA

Amra Racic, Medtronic PLC

ModeratorNancy Singer, Compliance-Alliance

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Agenda

• Overview of FDA’s Inspection Process –LCDR Collins Mason, Supervisor Investigator, FDA Baltimore District Office

• Interactive Moderated Panel Discussion

• Opportunity to Ask Questions

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Collins M Mason LCDR, USPHSSCSO, Baltimore District (BLT-DO)Food and Drug Administration (FDA) 4

Who are we: General overview of FDA’s BLT-DO.

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Baltimore District (BLT-DO)BLT-DO

BLT-IB

DOG1-Foods

G2-DMT-Imports/All

G3- Biologics

MGN/All

G4-RCH-All

RCH-RP

RNK-RP

G5-NOVA-All

G6-Med Dev & Drugs

CST x 1CSO x 8-10

G7-SEVA-Imports/All

GDUFA

BLT-CB

Domestics

Imports

BLT-Admin

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BLT-IB Branch Make-up

Branch Director (DIB): Constance Richard-Math Deputy Director (DDIB): LCDR Cornelius Brown III 8 x Supervisory Consumer Safety Officers (SCSOs)

8 Groups 1 Import 1 GDUFA 2 Imp/Dom 5 Dom)

District Office 4 groups

Resident Post 4 groups

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BLT-IB Branch Make-up CTD.

Resident Posts (RPs) 4 groups

6 locations BLT-DO Baltimore District Office DMT-RP Dundalk, MD MGN-RP Morgantown, WV NOVA-RP Northern Virginia/Falls Church, VA RCH-RP Richmond, VA RNK-RP Roanoke, VA SEVA-RP Southeastern Virginia/Portsmouth,

VA Personnel makeup varies at RPs & DO

Typical Consumer Safety Officers/ (CSOs)/Investigators 10/group

Conduct Inspections 8-10 per RP or Group

Consumer Safety Technicians (CST) Provide admin & other support 1/RP or Group

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BLT-IB Branch Make-up CTD. Other IB Personnel

Consumer Complaint Coordinator Handle complaints

Program Support Specialists (PSS) Multiple tasks

Official Establishment Inventory (OEI) Coordinator Manage Inventory of regulated industry

Important operational changes Out of Business Registrations NOEI Profile changes Other related tasks

Work Products & Output Inspections-EIR

Defn: a careful, critical, official examination of a facility to determine its compliance with laws administered by FDA

Domestic & Foreign Samples- Collection Report

Domestic, Foreign, Imports Physical Product or Paperwork (documentary sample)

Perform Recall Activities Effectiveness checks - Form 3177 Attachment B Information

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Work Products & Output CTD.

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Perform Investigations - Memo Consumer Complaint follow-ups Injury and Adverse Reactions Foodborne Outbreaks Tampering Health Fraud Disasters Change in Business Operations

Perform Field Examinations Review of physical product

Surveillance Compliance

For cause …apparent violation Entry Review/Imports Operations Referrals from & to the States, OCI

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IB Source of Operations ORA/BLT-DO Workplan

Cycle based with factors depends on center/program area/risks ORA Performance Goals Workplan Assignments Ad Hoc Assignments

Diverse sources (see below) Assignments from the Centers

RTE cold cuts/swabbing Infant & Dried Cereal Egg Farms/Hatchery Compounding Pharmacy

Consumer Complaints Recalls Referrals from State, OCI

FDA Centers as Ops source CFSAN

Accounts for majority of work CDER CDRH CBER CVM CTP

Conducts it owns inspections

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Industry ProfileBALTIMORE DISTRICT OEI - ACTIVE FIRMS

TOTAL - 6,149

287547%

194432%

64510%

2664%

4197%

FOODSMEDICAL DEVICESHUMAN DRUGSBIOLOGICSANIMAL PRODUCTS

FY15 Based Data Sample

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Programs covered by IB (foreign/domestic)

CFSAN & Food Safety Fish and Fishery Products Interstate Travel Program Veterinary Medicine Feed

CVM BSE/Ruminant Feed Ban Medicated Feed

CDRH Medical Devices Mammography/X-Ray

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Programs covered by IB (foreign/domestic) CTD.

Drugs GMP Pre-approval)

Biologics Blood Banks, Plasma Human Tissue

Bioresearch Monitoring Program (BIMO) Imports Tobacco

Purpose and Types of Insp. (EI)

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Purpose defined by Program Assignment Code (PAC)

Drug, medical gas, medicated feed, general food Assignment Specs

Surveillance vs compliance Cycle

Abbreviated, comprehensive Types of EIs

Comprehensive Coverage of everything having to do with product(s) selected to

determine compliance Directed/Abbreviated

Coverage of specific areas to a depth described in assignment, in CP, or by SCSO

Stages of an Inspection?

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Prepping Getting ready for the Inspection/EI

Executing Conducting the Inspection/EI

Reporting Reporting the results of an Inspection/EI

Prepping for an EI Review

Previous inspections, CFRs, Compliance Programs, & Guidance documents

Assignment (including FACTS assignment) IOM (including subchapters 5.4-5.10) Proprietary FDA databases (registration, listing, complaints)

Talk to Agency personnel CSO who performed previous EI, SCSO District specialist Center contact

Preannounce if necessary CDRH, BIMO

Use Agency’s resources appropriately Prep time/time at firm is an agency resource

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Executing: General Opening Interview

Present Credentials Issue FDA 482 & other pertinent documents Discussion with staff

Start Inspecting Request documents & ask questions

Floor plan Product list What’s being manufactured?

Select process/product to cover

Tour facility/Walkthrough Familiarize yourself & verify the “live operation”

To plan/modify inspectional strategy Develop/modify inspectional plan

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Executing: Documenting

Obtain Information from knowledgeable persons Interview/observe personnel/process in action i.e. Live

Avoid releasing confidential information Reassure the firm collected info is proprietary

Maintain professionalism Keep the firm informed of findings (no surprises)

In real time & During daily closing discussions

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Reporting

Establishment Inspection Report (EIR) Sample Sections

Summary Administrative Data History Manufacturing/Design Operations Manufacturing Codes Complaints Recall Procedures Objectionable Conditions & Management Response Refusals General Discussion with Management Voluntary Corrections Exhibits Collected Attachments

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QUESTIONS??

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Please contact the following:

Constance Richard-MathConnie.Richard-Math@fda.hhs.gov

or

Cornelius Brown III, DIB, LCDRCornelius.brown1@fda.hhs.gov

The End

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Interactive Moderated Panel Discuss1. Panelists introduce themselves

2. Attendees participate in an interactive discussion

3. Opportunity to ask questions

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Who are we? Collins Mason Nancy Singer Gary Bird, Ph.D. Lori Hirsch Amra Racic

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Process Form small groups of 5-6 people. Briefly introduce yourself:

State your name, title and number of years at your organization.

Identify the chairperson: Person with the first letter of the last name closest to A.

From each slide describing a scenario, out of the four options listed, select ONLY ONE. (It should be the best option or the one you would do first.)

Reach consensus among the group members. If not, the chairperson chooses.

If you finish an individual question, discuss the extra credit question that will be handed out.

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Scenario 1The FDA investigator refuses to provide a daily briefing in a medical device inspection. You explain that there is a provision in the IOM that states the requirement for providing a daily briefing in a device inspection. The investigator still refuses. What do you do?

 a. Accept his decision as you don’t want to alienate the investigator.

b. Call the investigator’s supervisor.

c. Mention the investigator’s failure to provide the daily briefing in your response to the 483.

d. Call your lawyer and ask him/her to talk to the investigator.

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Scenario 2You company has been in business for 15 years. You manufacture a low risk device, and your company has not received any adverse incidents that would have required you to file an MDR. You discover that one of your employees has falsified information during complaint investigations in order to clear up the backlog of complaints. You correct the situation. What do you do?

 a. Write a corrective action plan, and then schedule a meeting with the District Director to discuss it.

b. Implement the corrective action plan and bring it up during your next inspection.

c. Put the issue into your CAPA system and don’t mention it to the FDA.

d. Call the Office of Compliance in FDA headquarters and explain the situation.

 

 

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Scenario 3The FDA investigator is new and writes numerous incorrect items on the 483. After explaining that you believe the items are not correct, you

 

a. Call his supervisor and explain the situation.

b. Accept the 483 observations and provide annotations stating “Under consideration.”

c. Acknowledge receipt of the 483 observations and write a comprehensive explanation in the response to the 483 explaining why you disagree with the observations.

d. Ask your company lawyer to talk to the investigator.

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Scenario 4Your company is located in Hamburg, Germany. A man arrives at your plant. He says he is from the FDA, shows his credentials, but does not provide a FDA 482. What do you do?

a. Let him in.

b. Ask him to call his office and have them fax the form to you.

c. Call FDA headquarter and ask for their advice.

d. Call the local authorities and have him arrested.

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Scenario 5You are the Quality VP. Your firm recently received a warning letter. You are implementing the corrective action plan that you provided in your response to the warning letter. A new FDA District Director has taken over. After she has been there for a several months, describe which of the following actions you would take in regard to getting acquainted.

 a. You schedule an appointment to explain that your firm is committed to taking corrective action.

b. You schedule an appointment and bring the company president along to show that your firm is committed to taking corrective action.

c. You do not schedule an appointment, but look for an opportunity, such as an educational event, to get acquainted.

d. You want to keep a low profile, so you do not reach out to her.

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Scenario 6The FDA investigator takes out his camera and begins to take photographs of your operations. You

a. Say that he can’t because you are obligated to operate in a state of control and follow your Quality System procedures, which doe not allow outsiders to take pictures.

b. Call your lawyer.

c. Call FDA’s Chief Counsel’s Office.

d. Allow the investigator to take the pictures.

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Develop Your SolutionThe next set of scenario are challenging situations that might occur during an FDA inspection. For each situation, groups should determine what they would say to the investigator.

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Question IThe FDA asked you for a specific record and, when you look in the file, it is missing or incomplete.

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Question IIOne of your firm’s employees provides incorrect information to the FDA investigator.

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Question IIIThe FDA investigator asks for a specific document, but the document doesn’t seem to satisfy the investigator’s concern.

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Question IVThe investigator asks you questions about top management’s commitment to quality and whether you have the required resources to do your job.

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Extra Credit ScenarioYour executive management refuses to provide adequate resources to fix the observations found by your internal auditor during her recent audit. They say, “During the last inspection, the investigator did not cite us for these deficiencies, so why should we spend the money now?”

How would you respond?

 

 

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Group DiscussionIn your small group, discuss might be the biggest challenge that companies have in regard to FDA inspections. Once you get agreement, raise your hand and you can ask the panel to comment.

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