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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
Warning: This talk has
not been evaluated
by the FDA.
For ConsumersHyperbaric 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 desire to smoke
NO 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 sleep
NO Strengthens your nervous system
YES
Claims
FTC—Unfair & Deceptive Practices
US - No False AdvertisingAll 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
High-touch
High-tech
Emergent
2009
2013
2018
230 240 250 260 270 280 290
Total Market for Anti-Aging Products and Services (in Billions of U.S. $)
Health
Vitality
Wellness
Youth
The 2nd Arabian Gulf Cooperation Council (GCC) Conference on Traditional & Complementary Medicine
CAM Therapie
s
Referrals to CAM Practitio
ners
Quirky ideas
Integrative care
(conventional + CAM)
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