FDA Law Outline

FDA Outline
Sunday, November 22, 2009
10:18 PM
 
Introduction and Background
 
Challenges of FDA Law
·         FDA Law and logic can seem bizarre (weird definitional issues, etc.)
o    Maggot v. leech (device v. drug)
o    Mouthwash can be a cosmetic, drug, OR device
o    Different regulation of frozen cheese and frozen pepperoni pizzas
o    Bottled water v. tap water (FDA v. EPA)
·         Circular definitions
o    Food = articles used for food or drink, makes statutory interpretation difficult
·         Policy issues
o    Ex. Terminal illness: you are terminal, don’t qualify for the clinical trial, do you have a right to try the new therapy (even though not approved)? You are going to die anyway, but…
·         Economic Issues
o    Now companies are spending more and getting less in terms of new drugs
o    High cost of drugs – to get anything back on investment, drugs must be sold at very high prices
·         Legal issues
o    Convoluted statues, lack of case law, role of regulations, role of guidance documents, policy decisions hidden in narrow regulations, regulatory drift, jurisdictional issues, regulatory logic can be obtuse
 
FDA Overview
·         Mix of law, public policy, science, medicine and politics
·         Long institutional memory impacts decisions
o    Thalidomide and Dr. Kelsey – historically FDA is a very conservative organization (approval can lead to illness/death)
o    Poison Squad – testing of food additives, go to great extents to protect public health
o    Generic drug scandal – negative history
·         Helped develop administrative law – old line administrative agency
·         Health care policy makers
o    Congress
o    Executive branch (white house, HHS, etc.)
o    FDA – what therapies are available, cost profile, safety and efficacy
o    Physicians and physician groups
o    Payors – CMS, payment, coverage, rationing, private carriers
o    Patients and advocacy groups
·         Health Care Policy
o    FDA gets involved into many policy debates (must balance competing policies that are often inconsistent)
·         Life style issues – tobacco, obesity
·         1st Amendment rights – promotion restrictions
·         Personal choice issues – abortion rights, dietary supplements
·         Right to treatment – unapproved products
·         Health care cost
·         Economic fraud
·         Product liability
·         FDA Mission §393(b)
o    Shows its paradoxical role (assuring safety and efficacy BUT making new products available fast)
o    Promote public health by promptly reviewing clinical research and marketing applications
o    Ensure that: foods are safe, drugs/devices are safe and effective
o    Global regulatory harmonization – consultation with experts, consumers, manufacturers, etc.
o    Advance public health (role of lifestyle choices)
o    Affordability of products
o    Information sources
·         Major FDA Policy Debates
o    Assist with approvals or act in a command/control fashion
o    Encourage new therapies (new developments include risk, the known is less risky)
o    Information v. control – who decides, the individual or the FDA?
o    Determine risk/benefit ratio (penicillin v. Rogaine)
o    Local v. national v. global control
·         Key reminders
o    FDA doesn’t regulate the practice of medicine
o    Source of FDA’s authority is interstate commerce
o    Definitions are KEY (jurisdiction, regulatory structure)
o    Other agencies have related authority (USDA, CMS, FTC, EPA)
·         FDA Structure
o    Part of HHS
o    Lead by commissioner – congressional approval of
o    The key subparts
·         Programs offices (Centers)
·         Field offices
·         General and administrative (Chief counsel’s office, policy legislative activity, etc.)
·         Development of FDA Law
o    2 key drivers for new FDA laws (health crisis, political pressures) – congress and FDA often reactive
o    Rise of consumerism
o    Role of stakeholders – industry, public interest groups, issue specific advocacy groups
o    FDA regulatory systems have followed key social, political and scientific movements
·         Urbanization, industrialization, health care capabilities, heal and life expectations, new technologies, computers and information technology, globalization, patient control
 
Legal Hierarchy
·         Statutes – primarily the FDCA (also PHSA, USDA, FTC)
·         Regulations – notice and comment rulemaking, CFR/Federal Register publication
·         Guidance documents – non-binding expressions of policy, regulations in disguise?
·         Desk procedures/SOPs/common practice
 
Key Concepts
·         Is the product regulated
o    Jurisdiction/definitions
·         What is the regulatory structure
o    Premarket approval?
o    Labeling requirements?
o    Manufacturing requirements?
·         Is the product:
o    Adulterated or misbranded?
 
Administrative Law
·         Basics:
o    Standard administrative law issues apply to FDA – APA process
o    Chevron type deference
o    Challenges to final agency action – procedural due process issues
o    Hearing requirements – notice, opportunity to be heard (one reason why so slow)
o    General administrative law procedures – 21 USC §371
·         Rule Making and Guidance
o    Formal rules or regulations: defined process, lengthy to create and hard to changes, ability to challenge
o    Guidance documents: agency policy, not requirements, practical and detailed, faster and easier to create