US Life Sciences Market: Key Legal Features/media/files/... · PMA . 13 Dietary Supplement...
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US Life Sciences Market: Key Legal Features March 26, 2013
Transcript of US Life Sciences Market: Key Legal Features/media/files/... · PMA . 13 Dietary Supplement...
US Life Sciences Market:
Key Legal Features
March 26, 2013
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Navigating the U.S.
Food and Drug Administration
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2012 FDA Organization
CDRH
Center for Devices
and Radiological Health
FDA
Center
For Tobacco
CFSAN
Center for Food Safety
and Applied Nutrition
CBER
Center for Biologics and
Evaluation Research
CVM
Center for
Veterinary Medicine
CDER
Center for Drugs and
Evaluation Research
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2013 FDA Organization
Office of
Global Regulatory
Operations and
Policy
Office of
Food and
Vet Medicine
Office of
Medical Products
and Tobacco
Office of
Operations
FDA
Office of
Commissioner
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Regulatory Framework
• Federal Food, Drug, and Cosmetic Act (“FDC Act”)
• Code of Federal Regulations (“CFR”)
Implements the statutory provisions of the FDC Act
Title 21 – Covers FDA regulations on food and drugs in “Parts”
• Guidance Documents
• Compliance Manuals
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Regulatory Pathways
for Market Entry
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Food Regulation Key Agencies and Statutes
Food and Drug Administration
• Federal Food, Drug, and Cosmetic Act
• Fair Packaging and Labeling Act
• Bioterrorism Act of 2002
United States Department of Agriculture
• Food Safety and Inspection Service
Federal Meat Inspection Act
Federal Poultry Products Inspection Act
Federal Egg Products Inspection Act
• Animal Plant Health Inspection Service
Animal Health Protection Act
Plant Variety Protection Act
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Food Regulation - Key Points
• Safe for Human Consumption
• Not Adulterated
• Not Misbranded (Properly
Labeled)
• Facility Registration
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Drug Regulation - The Basics
• The Center for Drug Evaluation and Research (“CDER”)
• Types of Drug Regulated:
- Rx (Branded and Generic)
- Over-the-Counter
- Homeopathic
• Drug Definition [21 U.S.C. § 321(g)(1)]:
- Official Compendia
- Intended for use in diagnosis, cure, mitigation, treatment, or
prevention of disease in man or other animals
- Intended to affect structure or function of body of man or animal
- Any component of items 1-3 above.
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Investigational New Drug (“IND”) Application
New Drug Application (“NDA”)
Pre-market review and approval
Safety & Efficacy
Current Good Manufacturing Practices
(“cGMPs”)
User Fees
Drug Regulation - Approval Basics
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Medical Device Regulation - Classification
3 Classes of Medical Devices Based on Perceived Risk and
Control Levels
• Class I (low risk)
General Controls
• Class II (medium risk)
Special Controls
510(k) Notification
• Class III (high risk and novel devices)
Special Controls
PMA
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Dietary Supplement Regulation - Definition
A product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients:
• Vitamins
• Minerals
• Herbs or other botanicals
• Amino acids
• Concentrate, metabolite, constituent, extract or combination of above listed ingredients
Under the Food, Drug and Cosmetic Act, dietary supplements are
regulated as a category of foods, and have been since at least
1938
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Cosmetic Regulation – Characteristics
• Articles intended for Cleansing (except some soap)
• Beautifying
• Promoting Attractiveness
• Altering appearance
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Cosmetic Regulation - Products
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Introduction to Labeling,
Marketing and Promotion
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• Immediate Container
• Package Insert
• Outer Packaging
• Shipping Label
• Client Information Sheet
The Product Label – What is Included?
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Product Labeling – What is it?
All marketing and promotional materials including:
• websites (product sites, meta tags)
• detailers / brochures
• trade show materials (handouts, posters)
• publications (journals, magazines)
• advertisements (TV and radio ads, internet pop-ups)
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The Standard for Adequate Substantiation
• Competent and Reliable Scientific Evidence
FTC standard relied on by FDA
"tests, analyses, research, studies, or other evidence based on the
expertise of professionals in the relevant area, that has been conducted
and evaluated in an objective manner by persons qualified to do so, using
procedures generally accepted in the profession to yield accurate and
reliable results." See Vital Basics, Inc., C-4107 (Consent April 26, 2004);
see also In Re Schering Corp., 118 F.T.C. 1030, 1123 (1994).
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Types of Claims & Risks
1) Disease Claims
2) Unsubstantiated Claims
of Effectiveness
3) Fair Balance / Omission of
Risk Information
4) Unsubstantiated Superiority
Claims
5) Consumer
Testimonials
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Enforcement Action
and Mitigating Risk
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Avoiding FDA Enforcement Action
• Untitled Letter
• Warning Letter
• Seizure
• Injunction
• License Revocation
• Criminal Penalty
• Civil Money Penalty
• Disgorgement of Profits
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How Does FDA Find Out About Violations?
• Inspections
• Random Sampling
• Adverse Event Reports
• International Cooperation
• Trade Complaints by Competitors
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Patentability - Outline
• Patents are awarded to subject matter that is:
Patentable subject matter
Useful
Novel
Non-obvious
Described and enabled
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Patentable Subject Matter
• Categories
Processes, machines, manufactures, compositions of matter
– Excludes
» Transitory signals
» Naturally occurring organisms
» Human beings
• Exceptions
Laws of nature, physical phenomena, abstract ideas
Unless
– Practical application of an exception
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Useful Subject Matter
• Criteria
Credible
– Accepted by one of ordinary skill in the art
Specific
– Specific to subject matter claimed, not to class of the invention
Substantial
– Real world use
• Examples
Treating or preventing microbial infection
DNA fragment
Uncharacterized protein
Isolated protein for treating Alzheimer’s disease
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Novel Subject Matter – Effective March 16
• All elements of subject matter are not in the prior art
• Prior art
All patents, printed publications, public uses, on sale, or available to
the public
– Before filing date of patent application
All patents and published patent applications by another worldwide
– With earlier effective filing dates
– “Worldwide” differs from EP practice
• Exceptions
Disclosure by or from inventor within one year of filing
Commonly owned patents and patent applications
Both differ from EP practice
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Non-Obvious Subject Matter – March 16
• Differences between the claimed invention and the prior art
• Claimed invention as a whole would have been non-obvious to a
person of ordinary skill in the art
Substantial differences from prior art
Insubstantial differences, with evidence of unexpected results
• Prior art includes patent applications earlier filed
Differs from EP practice
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Patent Application
• Claims, claims, claims
• Detailed description
How to make and use the invention
Best mode
– Differs from EP practice
• Drawings
Optional
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Patent Examination
• Subject matter
• Utility
• Novelty
• Non-obviousness
Often contentious
• Description and enablement
Also often contentious
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Post-Grant Proceedings – March 16
• Ex parte reexamination
• Post grant review
Novelty, obviousness, written description, enablement, indefiniteness,
subject matter
Trial at the Patent Trial and Appeal Board
12-18 months
• Inter partes review
Prior patents or printed publications
Trial at the Patent Trial and Appeal Board
12-18 months
• Transitional program for covered business methods
Method or apparatus for data processing
– Except for technological inventions
May be filed by party charged with infringement
Any grounds of unpatentability
Dynamics of the Research
and Development / Clinical
Trials Market in the US
Maureen Bennett
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Dynamics of US R&D/Clinical Trials
• Global Dynamics
Continued Impact of Patent Cliffs
Continued Impact of Health Care Reform/Pricing Pressures
Consolidation of In-house R&D resources
Increased in Industry Joint Development Programs
Increased outsourcing to CROs/AROs/Specialty Providers
Variable availability of capital from financial markets
Variable Availability of Government Funding/NIH in the US
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Dynamics of US R&D/Clinical Trials
• New Models of Innovation
Transcelerate
Industry/AMC Broad Collaboration Platforms
Target Validation Consortium
State Programs
Personalized Medicine/Unmet Needs
Social Media Recruitment
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Dynamics of US R&D/Clinical Trials
• Recent US Regulatory Developments Affecting Clinical Trials
New HITECH Regulation-Flexibility in Authorizing Future Research
FDA Approval of Remote Clinical Trial Monitoring
HHS Consideration of Centralized IRBs
FDA Final Guidance re: Financial Disclosures
Physician Payment in the Sunshine Act
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Dynamics of US R&D/Clinical Trials
• Negotiating Clinical Trial Agreements with US
AMCs/hospitals/physician practices
• Contrast with UK System
No model agreements like NHS Trust
Variation in budget formats
IRBs
No regulatory requirement for insurance, but…
Indemnity negotiations
PI Oversight Issues
For questions regarding
CLE credit, please contact:
Robin Hallagan
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Worldwide Locations
• Cincinnati
• Cleveland
• Columbus
• Houston
• Los Angeles
• Miami
• New York
• Northern Virginia
• Palo Alto
• Phoenix
• San Francisco
• Tampa
• Washington DC
• West Palm Beach
• Bogotá+
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• Bucharest+
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