US Life Sciences Market: Key Legal Features March 26, 2013
US FDA Update Karl M. Nobert karl.nobert@squiresanders.com
Navigating the U.S. Food and Drug Administration 3
2012 FDA Organization CDRH Center for Devices and Radiological Health CDER CBER Center for Drugs and Center for Biologics and Evaluation Research Evaluation Research FDA CVM CFSAN Center for Center for Food Safety Veterinary Medicine and Applied Nutrition Center For Tobacco 4
2013 FDA Organization Office of Office of Global Regulatory Food and Operations and Vet Medicine Policy FDA Office of Commissioner Office of Office of Medical Products Operations and Tobacco 5
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 6
Regulatory Pathways for Market Entry 7
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 8
Food Regulation - Key Points • Safe for Human Consumption • Not Adulterated • Not Misbranded (Properly Labeled) • Facility Registration 9
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. 10
Drug Regulation - Approval Basics Investigational New Drug (“IND”) Application New Drug Application (“NDA”) Pre-market review and approval Safety & Efficacy Current Good Manufacturing Practices (“cGMPs”) User Fees 11
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 12
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 13
Cosmetic Regulation – Characteristics • Articles intended for Cleansing (except some soap) • Beautifying • Promoting Attractiveness • Altering appearance 14
Cosmetic Regulation - Products 15
Introduction to Labeling, Marketing and Promotion 16
The Product Label – What is Included? • Immediate Container • Package Insert • Outer Packaging • Shipping Label • Client Information Sheet 17
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) 18
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). 19
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 20
Enforcement Action and Mitigating Risk 21
Avoiding FDA Enforcement Action • Untitled Letter • Warning Letter • Seizure • Injunction • License Revocation • Criminal Penalty • Civil Money Penalty • Disgorgement of Profits 22
How Does FDA Find Out About Violations? • Inspections • Random Sampling • Adverse Event Reports • International Cooperation • Trade Complaints by Competitors 23
IP Portfolio Protection Rahul Pathak, Ph.D. J.D. rahul.pathak@squiresanders.com
Patentability - Outline • Patents are awarded to subject matter that is: Patentable subject matter Useful Novel Non-obvious Described and enabled 25
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 26
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 27
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 28
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 29
Patent Application • Claims, claims, claims • Detailed description How to make and use the invention Best mode – Differs from EP practice • Drawings Optional 30
Patent Examination • Subject matter • Utility • Novelty • Non-obviousness Often contentious • Description and enablement Also often contentious 31
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 32
Dynamics of the Research and Development / Clinical Trials Market in the US Maureen Bennett maureen.bennett@squiresanders.com
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 34
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 35
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 36
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