Arnold & Porter US and EU Drug and Device Enforcement Boot Camp

402 Pages·2015·11.58 MB·English

Arnold & Porter
US and EU Drug and Device
Enforcement Boot Camp
April 30, 2015
Summit, New Jersey
arnoldporter.com
Arnold & Porter
US and EU Drug and Device
Enforcement Boot Camp
April 30, 2015
Grand Summit Hotel, Summit, New Jersey
Table of Contents
Presentation Slides .............................................................................................................................Tab 1
Arnold & Porter Speaker Biographies ..............................................................................................Tab 2
Dan A. Kracov, Ian Dodds-Smith, Vernessa T. Pollard, Philip R. Desjardins, Adela Williams, Lincoln Tsang,
Daniel S. Pariser, Alison Brown, Marilyn May
Practice Brochures .............................................................................................................................Tab 3
„ FDA and Healthcare
Articles and Advisories ......................................................................................................................Tab 4
„ “21st Century Cures: what’s brewing for medical technology?,”
Informa UK Ltd 2015, April 2015
„ “FDA Deregulates Medical Device Data Systems and Certain Low Risk Health and Wellness Mobile Applications,”
Arnold & Porter LLP Advisory, February 2015
„ “Interoperability High on the Health Information Technology Agenda for 2015,”
Arnold & Porter LLP Advisory, February 2015
„ “What to Expect in 2015: An Overview of Potential Pharmaceutical Regulatory, Policy and Enforcement
Developments,”
Arnold & Porter LLP Advisory, January 2015
„ “FDA Issues New Guidance, Classification Pathway on Medical Device Accessories,”
Arnold & Porter LLP Advisory, January 2015
„ “UK Introduces Patent Infringement Exemption to Encourage Clinical Trials,”
Arnold & Porter LLP Advisory, October 2014
„ “The European Medicines Agency’s new policy on the proactive disclosure of clinical trial data,”
Arnold & Porter LLP Advisory, October 2014
„ Recent Appellate Decisions Suggest Significant Limits on the Use Of the False Claims Act to Police Alleged Violations
of FDA Regulations
„ Frontline of Health-Care Defense: Building Credibility for Corporate Counsel in Fraud Investigations
Supporting Materials ..........................................................................................................................Tab 5
„ Settlement agreement
„ United States of America v. Ranbaxy USA, Inc.
„ Statement of Facts-Ranbaxy USA, Inc.
„ Resolutions of The Board of Directors of Ranbaxy USA, Inc.
„ U.S. Files Consent Decree for Permanent Injunction Against Pharmaceutical Ranbaxy Laboratories
„ Generic Drug Manufacturer Ranbaxy Pleads Guilty and Agrees to Pay $500 Million to Resolve False Claims
Allegations, cGMP Violations and False Statements to the FDA
„ Memorandum Opinion
Tab 1: Presentations
arnoldporter.com
FDA and EU Drug and Device
Enforcement Boot Camp
April 30, 2015
Summit, New Jersey
Agenda
1. Welcome and Introductions
2. Overview of Hypothetical
3. FDA and EU Enforcement: History, Authorities, Approach,
and Trends
4. FDA Inspections
5. Key FDA Documents: 483s, EIRs, and Warning Letters
66. EUU Inssppeeccttioonss
7. EU Enforcement: Response and Resolution
8. US Injunctions and Consent Decrees
9. Collateral Consequences of FDA and EU Enforcement
2
Panel Members
Daniel Kracov,Partner and FDA and Healthcare Practice
Co-Chair, Washinggton, DC
Ian Dodds-Smith,EU Life Sciences Partner and Practice
Co-Chair, London
Vernessa Pollard,FDA and Healthcare Partner,
Washington, DC
Lincoln Tsang,EU Life Sciences Partner, London
Adela Williams,EU Life Sciences Partner, London
3
Panel Members
Alison Brown,EU Life Sciences Partner, London
Daniel Pariser,Product Liability Partner, Washington, DC
Philip Desjardins,FDA/Healthcare Counsel, Washington, DC
Marilyn May,FDA/Healthcare Counsel, Washington, DC
4
Disclaimer
This program includes a hypothetical that incorporates various
ffiicttiittiious companiies, iinddiiviiddualls, prodductts, andd scenariios. AAny
resemblance to actual companies, individuals, products, or scenarios
is unintentional. No aspect of this program should be deemed to
reflect the position of any company or individual, or a waiver or
admission in any respect.
5
Fortus, Inc.
 Medium-sized US-based life
sciences company, with 5000
employees and $5 billion in
revenue
 Therapeutic areas of focus include
diabetes and anemia
6
Dermalin Diabetes Management System
 Prescription insulin pump indicated for
conttiinuous subbcuttaneous iinsulliin iinffusiion
for the control of Type 1 diabetes in
adults and children 12 years and older
 Pump is programmed to deliver a
continuous dose of insulin, but a patient
can also program the pump to administer
an extra dose at pre-set intervals, or as
nneeeeddeedd, wwiitthhiinn pphhyyssiicciiaann-sseett ppaarraammeetteerrss
 Pump is manufactured for Fortusby
Arnold Diagnostics, Inc., a contract
manufacturer, with facilities in the UK
and US
7
Dermalin Diabetes Management System
 Marketed for use with Fortus’
pprreessccrriippttiioonn iinnssuulliinn ddrruugg MMoovvaaddeerrmm((pprree-
filled cartridges that are inserted into the
pump)
 Movadermis also manufactured in the
UK
 Movadermand pump have been
approved by FDA and Movadermwas
centrally approved by the
EMA/European Commission
 Pump has been separately assessed by
the Notified Body, BSI, in the UK
8
FDA and EU Enforcement: History,
Authorities and Approach
Vernessa Pollard and Ian Dodds-Smith
FDA Enforcement: History,
Authorities and Approach
Vernessa Pollard
FDA’s Approach to Enforcement
“Effective enforcement has many clear benefits
to public health…By holding violators
accountable, enforcement deters others who
would put the public at risk or prey upon
vulnerable consumers. Visible and clearly
explained enforcement actions inform…the
public about potential dangers…[and] helps
industry…by maintaining a level playing field for
safe products. Making sure that offenders are
held legally accountable prevents companies
from having to choose between doing the
rightthingandstayingcompetitive.”
Remarks by Former Margaret A. Hamburg, MD, Commissioner of Food and Drugs on "Effective
Enforcement and Benefits to Public Health,” Food and Drug Law Institute, August 6, 2009 11
FDA Organization as of April 2015
Office of The
Chief Counsel
Office of Global
Regulatory
Operations and
Policy
Center
Compliance
Offices
Office of
Regulatory
Affairs
12