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Overall Planning
Working With FDA
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CMC Issues
Safety Issues
Labeling
Ingredients – Active And Inactive
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* CMC and Design History Issues
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* Ingredients –Active And Inactive; Component for Medical Devices
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• Overall Planning
• Working With FDA
• Clinical Trial Execution
• CMC Issues
• Safety Issues
• Labeling
• Ingredients –Active And Inactive
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“Tools of the trade”; what are they?
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What does the Client bring to the table?
Why are you there?
How do you adapt & why do should you?
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Enforcement Trends Prior to Obama Administration
Commissioner Hamburg Revives FDA’s Compliance
Culture – The August 6, 2009 Speech and its Impact
How to Prepare for Increased Enforcement
How to Respond if Targeted
Consequences of Non-Compliance
Ensuring FDA Regulatory Success for Biomedical Companies -- Key Lessons for S...Michael Swit
Supporting Materials for Michael Swit's Panel remarks at the Workshop Co-sponsored by the Orange County Regulatory Affairs (OCRA) Discussion Group and the Small Business Development Center (SBDC) @ UCI Applied Innovation
Drug Development in Today's Regulatory EnvironmentMichael Swit
Webinar sponsored by NanoTecNexus (www.http://nanotecnexus.org/) on contemporary regulatory issues in drug development, with an emphasis on:
Overall Planning
Working With FDA
Clinical Trial Execution
CMC Issues
Safety Issues
Labeling
Ingredients – Active And Inactive
Ensuring FDA Regulatory Success for Biomedical CompaniesMichael Swit
February 27, 2008 presentation to the Israeli Life Sciences Fellows of the Merage Foundation on product development issues, including:
* Overall Planning
* Working With FDA
* Clinical Trial Execution
* CMC and Design History Issues
* Safety Issues
* Labeling
* Ingredients –Active And Inactive; Component for Medical Devices
REGULATORY AND OTHER PITFALLS IN DRUG DEVELOPMENTMichael Swit
Presentation to the Pharmaceutical Education Associates
"From Pipeline to Product: Navigating the FDA Approval Process" conference in Alexandria, VA, on November 30, 2007, with a focus on:
• Overall Planning
• Working With FDA
• Clinical Trial Execution
• CMC Issues
• Safety Issues
• Labeling
• Ingredients –Active And Inactive
What is a Testing Framework?
“Tools of the trade”; what are they?
Test Phases, Test Stages, Testing Activities, Verification Methods, a Testing Workflow, Status Reporting, Test Types
Discussions:
What do you bring to the table?
What does the Client bring to the table?
Why are you there?
How do you adapt & why do should you?
The document discusses various topics relating to quality audits, including definitions, the purpose and types of audits, auditor skills and conduct, and potential problems auditors may encounter. It defines key terms like assessment, audit, compliance, and defines a quality audit. It outlines the purpose of audits is to provide objective feedback to enable management decisions. It also discusses auditor skills like competence, communication, listening, independence, observation, objectivity, and judging. Finally, it discusses problems like antagonism, time wasters, evasiveness, sympathy, glossing, and bribery and how auditors should address them.
The document provides guidance on preparing for a pre-approval inspection (PAI) by the FDA. It discusses understanding what to expect from an FDA inspection team, developing an inspection management plan, and preparing the facility and documentation. Key steps include conducting internal audits and mock inspections, training personnel, reviewing documents that will be examined, and designating an inspection team to manage document requests and escort inspectors. The goal is to demonstrate compliance and control over any issues, rather than hiding problems from inspectors.
FDA’s New Strategy on Enforcement: The Growing Perils of Inadequate ComplianceMichael Swit
September 9, 2009 webinar sponsored by The Weinberg Group, with a focus on FDA's renewed commitment to enforcement announced by FDA Commissioner Hamburg on August 6, 2009, with a focus on:
Enforcement Trends Prior to Obama Administration
Commissioner Hamburg Revives FDA’s Compliance
Culture – The August 6, 2009 Speech and its Impact
How to Prepare for Increased Enforcement
How to Respond if Targeted
Consequences of Non-Compliance
Ensuring FDA Regulatory Success for Biomedical Companies -- Key Lessons for S...Michael Swit
Supporting Materials for Michael Swit's Panel remarks at the Workshop Co-sponsored by the Orange County Regulatory Affairs (OCRA) Discussion Group and the Small Business Development Center (SBDC) @ UCI Applied Innovation
Regulatory Considerations in Product DevelopmentMichael Swit
Presentation to the LARTA (www.larta.org) NIH-CAP Workshop in November 2011 on how to develop FDA-regulated products, with a focus on planning, working with FDA,
Regulatory, Quality & Clinical Due Diligence: The Oft Overlooked Keys to Suc...Michael Swit
June 23, 2010 webinar sponsored by The Weinberg Group, with an emphasis on key issues to explore during due diligence in acquiring FDA-regulated products or companies.
FDA Inspections: Handling the Consequences. Dealing with the aftermath of an...Michael Swit
Presentation at annual MAGI conference, focusing on FDA inspections, covering:
Enforcement Trends Prior to Obama Administration
Commissioner Hamburg Revives FDA’s Compliance Culture –The August 6, 2009 Speech and its Impact
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Consequences of Non-Compliance
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FDA Regulation of Promotion & Advertising -- Part 8: Handling Promotional Co...Michael Swit
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The Small Company Clinical Study Sponsor -- Roles & Duties Vis-à-vis LiabilityMichael Swit
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* Analyzing degrees of liability between bigger and smaller companies
* Ensuring that you are enforcing compliance from your outsourcing partners to avoid repercussions on yourselves
* Determining aspects of your trial management that you should retain in-house as a minimum so as to avoid liability issues
* Explaining to funders why quality and risk-assessments are a necessary expenditure above the cheapest options
FDA Regulatory Considerations for Life Sciences CompaniesMichael Swit
April 2008 presentation to Swedish-American Chamber of Commerce Entrepreneurial Days on FDA issues for product development, including focus on:
Planning, approval process, barriers to entry
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FDA Enforcement -- the Perils of Inadequate ComplianceMichael Swit
This document summarizes a presentation about increased FDA enforcement of compliance. It discusses trends in FDA inspections, warning letters, seizures, and injunctions prior to 2009. It outlines a 2009 speech by FDA Commissioner Hamburg that revived the agency's compliance culture and established new enforcement mandates, including imposing deadlines for inspection responses, prioritizing follow-up on warnings, and taking rapid action when public health is at risk. The presentation advises preparing for enforcement by establishing a culture of compliance, building robust quality systems, and responding promptly and completely if targeted. It notes the serious consequences of non-compliance for companies and individuals.
FDA Regulatory Considerations for the Biomedical CompaniesMichael Swit
Presentation to the LARTA (www.larta.org) NIH-CAP Workshop in October 2007 on how to develop FDA-regulated products, with a focus on planning, working with FDA, regulatory pitfalls, clinical studies, etc.
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REGULATORY AND OTHER PITFALLS IN DRUG DEVELOPMENT
1. American Chemical Society
San Diego Section
Michael A. Swit, Esq., Vice President
18 November 2009
REGULATORY AND OTHER
PITFALLS IN DRUG
DEVELOPMENT
2. 1
DISCLAIMER
This outline is intended to support an oral briefing and
should not be relied upon solely to support any conclusion of
fact or law.
The views reflected in this presentation are solely those of
the presenter and do not necessarily reflect the position of
my firm, any of its clients, or any of my friends and
colleagues that contributed their thoughts to this
presentation.
3. 2
WHERE THE PITFALLS LIE
Overall Planning
Working With FDA
Clinical Trial Execution
CMC Issues
Safety Issues
Labeling
Ingredients – Active And Inactive
Final Sermons
4. 3
OVERALL PLANNING
Create A Project Plan With Well-defined Go/No-go
Decision Points –
Difficult, But Vital To Know When To Shift Gears.
Plan With The End In Mind – your ultimate labeling will
drive what you need to do – create a “Product Profile” early
and try to stick to it.
5. 4
OVERALL PLANNING …
Make Sure You Are Ready To Go From “R" to “D"
Internally - people and systems; change in mindset from research
to development.
Formulation Has Been Rigorously Reviewed -- so as to
optimize your chances when going into humans.
Once Clinical Evaluation With A Compound Begins,
Preclinical Efficacy Experiments -- should be limited or undergo
rigorous review and oversight.
Educate Scientists And Researchers – on the realities of the
demands of development, especially documentation
Example -- report writing -- may be a weakness in research, but
is important in development. Start early in the process.
6. 5
OVERALL PLANNING …
Make Sure Regulatory, Clinical, And Sales &
Marketing Are All Talking Early On –
Ensure Indication (thus, Endpoints) Being Studied Is One
You Want To Sell
Some Considerations --
Study Design –while marketing may want superiority if you go
for that sort of study and fail, the FDA won‟t let you
reanalyze the study for non-inferiority -- hence failed
development program…
Indication Choice – consider limited initial indication that can
be the starting point for subsequent bigger indications
can be key to optimal product lifecycle management
7. 6
OVERALL PLANNING …
Beware of "Divergent Evolution" between Product
Development and Intellectual Property Efforts!
How Patents Can Evolve
Attaining patent protection for a novel chemical entity or
formulation is a multiyear process
In patent process, claims often become more limited in number
and in scope, due to prior art, Patent Examiner concerns, etc
Ensure A Strategic Linkage Between The Product
Development And Patenting Efforts -- to best assure:
Patent(s) granted actually cover critical features of the product
being studied in clinicals
Clinicals actually cover patented/able claims
8. 7
OVERALL PLANNING …
Understand Approval Is Not Enough, Somebody
Has to Pay for It!! - coverage (on formulary) and
reimbursement (at a reasonable co-pay tier).
Some keys:
Label claims -- Is there anything novel you can say?
Comparative effectiveness:
future of reimbursement
future for competitive/comparative claims – clinicals will be
needed (FDA/FTC)
9. 8
OVERALL PLANNING …
Other Key Planning Efforts
Product Name –
Globalize the product name (be careful with different meanings)
Seek regulatory agency concurrence early.
Find Collateral Support; e.g., Patient Groups, Thought Leaders
can help with identifying investigators
can help with patient recruitment
Identify Enemies -- commercial and otherwise (e.g., special
interest groups)
Anticipate their moves (e.g., Citizen Petitions)
Pediatric Assessments -- -need a plan to address pediatric usage
Global Development – try to coordinate -- FDA may be the “gold
standard” – but that may be irrelevant in EU, Japan, etc.
10. 9
OVERALL PLANNING …
Management
Must Understand Process.
Must Support Company's Quality System, especially as a
company matures.
Don’t Let Financial Milestones Drive Development – recipe for
disaster (e.g., Refuse To Files, Clinical Holds).
Contrast:
“What is the minimum we need to do to get approval?"
vs.
"What is necessary for us to provide in order to get a first
cycle review approval".
[if your CEO thinks first option is OK, time to update your
CV]
11. 10
WORKING WITH FDA
Early interaction -- essential to understanding your
path and what you need in your kitbag
FDA encourages and appreciates (usually) being consulted
early in the development stage --
helps build a relationship with Agency that can pay off during the
approval process.
Take advantage of all Regulatory “value-added”
initiatives – e.g., Fast Track, Accelerated Approval, Orphan
Drug, SPA (but be careful on this)
12. 11
WORKING WITH FDA …
Ensure You Get Agency Agreement On Exactly What Is The
Indication – will drive related labeling language, especially those
related to disease, treatment or metrics
Example: “Chronic sinusitis”
Not in DSM or accepted text books -- really a term of art among ENTs.
Company
started clinical trials,
Then, went to FDA – “we’re treating chronic sinusitis!!”
FDA -- “what’s’ that?” -- leading to a rather lengthy debate about
symptomatology of “chronic sinusitis”.
Result – company had already studied something not entirely covered by
the now agreed upon definition of “chronic sinusitis” both as to:
outcomes
method of measuring
Consequence – also can end up proving a labeled indication that does not
jibe with original marketing projections
13. 12
WORKING WITH FDA …
Safety is Lynchpin Today –
Focus On Signals/AE’s Early
Ensure personnel evaluating are qualified
“REMS” –
“Risk Evaluation and Mitigation Strategies”
Future is now – due to Food & Drug Administration
Amendments Act of 2007 –
You Need to control REMS process; don‟t let FDA
Example: anticipate Phase IV, Post-Approval Study, but
drive its design
14. 13
WORKING WITH FDA …
Logistics:
Understand IND Regulations – especially on changes:
Amendments
Annual reports
Keep Detailed Records Of All Interactions between the
sponsor and the regulatory agencies.
After Submission -- Be Very Diligent with Follow-Up.
Ensure mandatory review milestones are achieved by the
reviewer.
“Force” dialogue if necessary.
15. 14
WORKING WITH FDA …
Logistics …
Respond To FDA Deficiency Letters and Other Comments
During Review Promptly, Fully, And Honestly
Know how the system works - if you don't agree with a reviewer's
decision, work up the chain of command
In responding to a deficiency letter:
Respond to FDA's comment in the first sentence.
Give clear and concise responses -- do not ramble and do not discuss
other topics.
In interacting with an FDA official, if you do not know the answer to
a query, do not guess.
Refer to a colleague who could provide the response. or tell reviewer
you will get back with correct reply
16. 15
WORKING WITH FDA …
Formal Meetings
Don’t Guess Who’s Coming to Dinner --
FDA: learn as much as possible about the regulatory agency meeting
attendees – background (full CVs, hot buttons, past publications)
Company: carefully pick who you will be taking to the meetings to
represent your company – internal people, consultants
Rehearse, Rehearse, Rehearse: a well-rehearsed meeting =
productive meeting
Anticipate questions -- have a plan of how and who will respond
Use outsiders to prepare – otherwise, you lose perspective
Consider technology assistance -- for advisory meetings
Hide your lawyers!!
unless there is a clear legal issue -- and FDA will bring in theirs
Outside Experts –
Use judiciously
Ensure qualified – and vette their publications and other statements
17. 16
WORKING WITH FDA …
Late in Review Process– a tip:
Prepare For An Advisory Committee Meeting, Even If
One Is Not Likely –
helps to marshall your arguments before hand should the regulatory
agencies signal a need to negotiate.
18. 17
WORKING WITH FDA …
Listen!!
If You Get Regulatory Agency Advice -- Do It!
(well, almost all the time)
Failure to adhere to any given advice may only subsequently
antagonize the reviewer.
Caveat -- If you don‟t want to do it or think it‟s wrong, engage
FDA promptly to gain its buy-in to your position
Don‟t just ignore FDA and go down your own path
Excellent science presented clearly -- essential
Keep your Promises!!
A sure way to lose credibility – fail to deliver what you promised
19. 18
CLINICAL TRIAL EXECUTION
Unfortunate, But Often Accurate Generalization --
failure to design and execute study properly too often
characterizes clinical studies at both small and even large
companies
Inadequate Toxicology Review Prior to Phase I – use an
outside set of eyes if you can
20. 19
CLINICAL TRIALS …
Poor Design Issues:
Result -- leads to protocol violations, deviations and half
effective amendments.
Consequence of deviations, violations -- study “mutates” –
progress and treatment of first patient barely resembles last
patient -- study population no longer homogeneous
Final Mutation -- heterogeneous population defies statistical
analysis
21. 20
CLINICAL TRIALS …
Primary Efficacy Endpoints
Must do adequate Phase 2 studies…dose, dosing regimens,
etc. so that you aren‟t second guessing the appropriate dose in
Phase 3
Be Sure Endpoint Is Validated And Acceptable to FDA
this includes Phase 2b studies
Involve Statisticians In Clinical Design
Don’t Delay Until Problem Occurs
Can Help Define The Study Design At The Correct
Stage -- speeds clinical development process
22. 21
CLINICAL TRIALS …
Key Opinion Leaders:
Include KOL’s In Clinical Program
But, don’t let Sales/Marketing drive this
Stark Act issues – distinguish KOL‟s from big „scribers
Financial disclosure challenges – cost of studies vs. consulting
fees
Physicians Payments Sunshine Act – legislation lurking in Health Care
Reform bills
23. 22
CMC ISSUES
Design Product Physical Characteristics To Be As
Robust As Possible
Validate And Qualify – e.g., dosage form, stability, content
uniformity
Keep A Lot History/Change Control System At The
Earliest Stage -- even if very rudimentary form (such as
memos to file)– it may be important later to track back to
what was done even at early stages
Ideally just as soon as something in "R" starts to show potential
of interest to those in "D"!
Do even if project is still under "Research" control -- don't wait
for a refined QA system to be implemented or for the
researchers to be trained in drug development concepts.
24. 23
CMC ISSUES …
Plan For Commercial Scale Production Early –
pre-NDA filing meeting is no time to learn that you need
additional stability or a bioequivalence study to qualify your
commercial product (e.g., larger scale, imprinting/debossing
etc.) against the one studied in development.
Track And Validate Changes In Processing And
Formulations –
ensure studied process/formulation will support
commercial process/formulation
25. 24
SAFETY
Detect As Early As Possible
Use Newer In Vitro Approaches to predict at potential
safety problems (if possible)
Cardiovascular Signals – Key Driver (e.g., HERG)
Dose-Response Data --
Seek Early On In Animal Studies (if possible)
Vital To Ensure Proper Dose for Phase II
26. 25
LABELING
FDA Concurrence On Main Indication -- NOT
Enough -- Must Get Sign-off on Other Key Label
Claims –
Example -- secondary endpoints
TIP -- Prepare optimal labeling and at least three
defensible fall-back positions for each key statement.
27. 26
OUTSIDE VENDORS
Audit Aggressively
Types: CROs, clinical investigators, contract manufacturers,
API makers, nonclinical testing facilities
Don’t Miss Any
Joint venture partners - e.g., Cialis® - Lilly manufacturing plant
problems - delayed about one year
MDS problems – analytical testing – delayed approvals
IRBs - have been shut down in past
Raw Material Suppliers – especially API – you do not want a
Heparin scenario
28. 27
OUTSIDE VENDORS …
How To Handle:
Audit SOPs, Training, Documentation & Follow-Up – keys
to auditing
If don‟t have internal expertise, hire qualified consultants (of
course, you have to qualify them)
Insist Contractors Include Sponsor On Document
Reviews, such as
Clinical Protocols
Manufacturing-related [master and production batch records,
analytical data, stability protocols/data, deviations, etc.]
Nonclinical [draft protocols and reports] documents.
29. 28
OUTSIDE VENDORS …
How To Handle:
Keep Control -- do not let a contractor direct your project
Avoid “CRO Creep” – use stringent and explicit contract
language
Liability - even when you outsource, you are ultimately liable
for what happens -- you still need to have systems and people
in place to ensure your vendors are working correctly
30. 29
INGREDIENTS – ACTIVE AND
INACTIVE
Assure Adequate Supplies -- of all components of
the product, packaging, etc.
Naturally-Derived Products
Supply Chain And Cost-of-goods – key issues down the
road as well as with potential investors –
Investigate Alternative (e.g., synthetic) Sources
Challenge or Opportunity? –
synthetic source may require new clinicals
may delay or bar generic competition
31. 30
FINAL SERMONS
Don't Bury Your Head To Problems -- investigate
and disclose promptly
Don't Fall Madly In Love With Your Technology –
You Have To Prove Safety And Effectiveness –
"I just know it works" -- not the standard in the Federal
Food, Drug, and Cosmetic Act –
… your baby may have some warts
32. 31
Call, e-mail, fax or write:
Michael A. Swit, Esq.
Vice President
The Weinberg Group Inc.
336 North Coast Hwy. 101
Suite C
Encinitas, CA 92024
Phone 760.633.3343
Fax 760.454.2979
Cell 760.815.4762
michael.swit@weinberggroup.com
www.weinberggroup.com
Questions?
33. 32
About your speaker…
Michael A. Swit, Esq., is a Vice President at The Weinberg Group, where he develops and ensures the execution of
a broad array of regulatory and other services to clients, both directly and through outside counsel. His expertise
includes FDA and CMS development strategies, compliance and enforcement initiatives, recalls and crisis
management, submissions and related traditional FDA regulatory activities, labeling and advertising, and clinical
research efforts for drug, biologic, device, IVD, and other life sciences companies, as well as those in the food and
dietary supplement industries.
Mr. Swit has been addressing critical FDA legal and regulatory issues since 1984. His vast and multi-faceted
experience includes serving for three and a half years as corporate vice president, general counsel and secretary of
Par Pharmaceutical, a prominent, publicly-traded, generic drug company and, thus, he brings an industry and
commercial perspective to his work with FDA-regulated companies. Mr. Swit then served for over four years as
CEO of FDANews.com, a premier publisher of FDA regulatory newsletters and other specialty information products
for the FDA-regulated community. His private FDA regulatory law practice has included service as Special Counsel
in the FDA Law Practice Group in the San Diego office of Heller Ehrman White & McAuliffe and with the Food &
Drug Law practice at McKenna & Cuneo, both in the firm’s Washington office and later in San Diego. He first
practiced FDA regulatory law with the D.C. office of Burditt & Radzius.
Mr. Swit has taught and written on a wide variety of subjects relating to FDA law, regulation and related commercial
activities, including, since 1989, co-directing a three-day intensive course on the generic drug approval process and
editing a guide to the generic drug approval process, Getting Your Generic Drug Approved. A former member of the
Food & Drug Law Journal Editorial Board, he also has been a prominent speaker at numerous conferences
sponsored by such organizations as RAPS, FDLI, and DIA. He received his A.B., magna cum laude, with high
honors in history, from Bowdoin College and his law degree from Emory University.
34. 33
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