Transcript here - SoCal IP Law Institute

Our Designer Future:
How FDA Legal Issues Shape Human Health–
From Medical Devices to Mobile Apps
SoCal IP
December 4, 2013
Michael H. Cohen, JD, MBA
Michael H. Cohen Law Group
468 N. Camden Dr.
Beverly Hills, California 90210
(310) 844-3173
www.michaelHCohen.com
For Consumers
Hyperbaric Oxygen Therapy: Don't Be Misled
Patients may be unaware that the safety and effectiveness of HBOT has not been established for these
diseases and conditions, including:
AIDS/HIV
Alzheimer's Disease
Asthma
Bell's Palsy
Brain Injury
Cerebral Palsy
Depression
Heart Disease
Hepatitis
Migraine
Multiple Sclerosis
Parkinson's Disease
Spinal Cord Injury
Sport's Injury
Stroke
Pop Quiz
You have a product and a website in the health
domain. How early should you get legal counsel and
determine the product’s likely regulatory status, and
the claims you can make?
a) During the planning phase.
b) While tweaking the website with your marketing
team in response to consumer demand.
c) As soon as you have $1 million in revenue.
d) In response to a warning letter from the FDA.
FDA Practice
• Cosmetics: “Articles intended to be rubbed,
poured, sprinkled, or sprayed on, introduced into,
or otherwise applied to the human body...for
cleansing, beautifying, promoting attractiveness, or
altering the appearance.”
• Drugs: “Articles intended for use in the diagnosis,
cure, mitigation, treatment, or prevention of
disease” and “articles (other than food) intended to
affect the structure or any function of the body of
man or other animals.”
Cosmetics v. Drugs
• Cosmetics
• No pre-marketing proof of safety or efficacy
• Labeling requirements
• Drugs
• FDA approval through NDA (proof of safety and
effectiveness).
• Conform to OTC monograph (specify conditions
where drug ingredients are generally recognized as
safe and effective, and not misbranded.
Foods & Dietary Supplements
• Foods
•
No pre-marketing proof of safety or efficacy
• Dietary Supplements
•
•
•
Vitamins, minerals, amino acids, herbs
Regulated like foods, not drugs (no NDA)
Cannot make “disease claims”
•
•
Calcium prevents osteoporosis
Can make structure/function claims
•
Calcium builds strong bones*
* This statement has not been evaluated by the FDA
*This product is not intended to diagnose, treat, cure or
prevent any disease.
Drug, Cosmetic, or
Medical Device?
Antidandruff
shampoo
Toothpaste with
fluoride
Antiperspirant
deodorant
SP50 moisturizer
“Cosmeceutical”
1. How do I know if my product is a
medical device?
2. How do I get the least burdensome
regulatory route to market?
Device?
(1)Is the product intended for use
to cure, mitigate, treat, or
prevent a disease?
(2)Is the product intended to
affect the structure, or
function, of the body?
General Controls (Class I)
•
•
•
•
•
•
•
•
Establishment registration
Medical Device Listing
Premarket Approval (PMA) if no predicate
Premarket Notification 510(k), if predicate
(unless exempt), or IDE (with clinical studies)
Quality System (QS) regulation
Labeling requirements
Medical Device Reporting
No adulteration or misbranding
Class of Device
• Device classification depends on
• Intended use
• Indications for use
• Objective test – shown by all advertising
material.
Does Your Intended Use Make
Your Product a Medical Device
• Product
• What it does
• Claims
• Classification Materials
• CDRH Classification Database
• FDA Device Classification Panels
• FDA
• Guidance documents
• Warning Letters
Type of product and what it does
•
Examples of objectionable claims:
Acne and skin problems
Birth Control
Control of Allergies
Emotional health
Enuresis
Hair loss
Hearing Loss
High blood pressure
Hyperactive children *or Adults*
Improving vision
Insomnia
Menstrual Control
Migraine headaches
Pain Control
Psychic healing
Wart Removal
Device?
• Intended to affect the
bodily function of
sleeping
• Intended to alleviate
insomnia
• Could divert consumers
from medication
• Even though consumers
testified product was
ineffectual!
•
U.S. v. 23, More or Less,
Articles, etc., 192 F.2d 308
(2d Cir. 1951)
Medical Device Claims
Smoking cessation
• “Reducing the desire to smoke” – acceptable, if
does not imply treatment of nicotine addiction,
relief of nicotine withdrawal symptoms, or
prevention or mitigation of tobacco-related
illnesses.
• “Smoking cessation”— implies treatment of
nicotine and is therefore a disease claim (=device).
• “can help you reduce or quit smoking habits”
1. Not a medical device – no regulation
2. Exempt device – no 510(k)
3. “Substantially equivalent” to a “predicate device” –
submit 510(k)
1. Class 1: general controls
2. Class 2: general controls and special controls (e.g.,
performance standards, postmarket
surveillance…)
4. No predicate device or Class 3 – submit PMA
Dietary
Supplement
Claims
Dietary Supplement Claims
Helps you sleep
Acceptable
Structure/function
claim (like “supports
sleep”).
Soothing Sleep
Acceptable
Label must clarify that
product is “for the
relief of occasional
sleeplessness.”
Helps you sleep if you
have difficult falling
asleep
Unacceptable
Implies insomnia cure.
Better sleep
Unacceptable
Implies insomnia cure.
Claims
Claim
Disease Claim?
Claim
Disease Claim?
Supports
weight loss
NO
Treats obesity
YES
Promotes
restful sleep
NO
Cures insomnia YES
Reduces the
NO
desire to smoke
Provides relief
from nicotine
addiction
YES
****************** Claims (indications for use) matter! *****************
Claims
Claim
Affects Structure or
Function?
Claim
Affects Structure or
Function?
Helps you
become more
confident
NO
Improves
digestion
YES
Improves
positive habits
NO
Increases
memory and
intelligence
YES
Promotes good NO
sleep
Strengthens
your nervous
system
YES
Claims
FTC—Unfair &
Deceptive Practices
US - No False Advertising
All advertising
claims must be
substantiated by
“competent and
reliable evidence.”
- US FTC
FTC - Substantiation
• Competent & reliable scientific evidence.
• “Nighttime magnetic field therapy has a calming and
sleep inducing effect on the brain and body due to
stimulating production of melatonin, an anti-stressful,
anti-aging and anti-infections hormone.”
• “Neptune Reducing Cream drops pounds and inches
from your thighs!!!!”
• “Today, there exists a safe, all-natural, bio-active weight loss
compound so powerful, so effective, so relentless in its
awesome attack on bulging, fatty deposits that it has
virtually eliminated the need to diet.”
• “Take it off! And keep it off!”
• “This product blocks fat before your body absorbs it; the
pounds will melt away effortlessly.”
• “I lost nine pounds during my first week eating just as I
always do — going to parties, even eating gobs of vacation
goodies, including my favorite food: ice cream. Four weeks
later, I’ve lost another 27 pounds.”
Takeaways
1. The alphabet soup of government
regulators is powerful.
• FDA (apples to apps)
• FTC (advertising)
• State Attorney General
Takeaways
2. Beware the Dark Side of marketing. A lot
depends on intended use.
Takeaways
3. Epistemological chaos reigns. “Deep
sleep” is ok but “better sleep” is not.
Brave New World
High-touch
High-tech
Emergent
Market Trends
Total Market for Anti-Aging Products
and Services (in Billions of U.S. $)
High-touch
High-tech
Emergent
2018
Health
Vitality
Wellness
Youth
2013
2009
220
240
260
280
300
The 2nd Arabian Gulf Cooperation Council (GCC)
Conference on Traditional & Complementary Medicine
Referrals
CAM
Therapie to CAM
Practitio
s
ners
Integrati
ve care
(convent
ional +
CAM)
Quirky
ideas
Riyadh
Accelerating Technological Progress
Thank you SoCal IP!
Michael H. Cohen Law Group
468 N. Camden Dr.
Beverly Hills, California 90210
(310) 749-4029
www.michaelHCohen.com