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Transcript of FDA: The Regulatory Environment and How it Affects You-- Current trends for Medical Devices June 14,...
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FDA: The Regulatory Environment and
How it Affects You--
Current trends for Medical DevicesJune 14, 2013
© 2013 DuVal & Associates, P.A.
Mark Gardner, M.B.A., J.D.
Attorney at DuVal & Associates, P.A.
Adjunct Professor of Law at Hamline University School of Law
(612) 382-7584
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Agenda
• Part 1: The U.S. Healthcare System• Part 2: FDA: The Regulatory Environment and
How it Affects You
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Where do you want to go?• “Would you tell me, please,
which way I ought to go from here? “
• “ That depends a good deal on where you want to get to,” said the Cat.
• “I don’t much care where—” said Alice.
• “Then it doesn’t matter which way you go,” said the Cat.
– Lewis Carroll -- Alice's Adventures in Wonderland, Chapter 6
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OVERVIEWThe U.S. Healthcare System
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Health care in the U.S.? It’s simple…
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Nearly ¼ of U.S. budget is
spent on health care!
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Return on Investment
Life Expectancy at Birth in the United States, 1900-2009 Source: Elizabeth Arias, "United States Life Tables, 2006," National Vital Statistics Reports 58, no. 21 (Hyattsville, MD: National Center for Health Statistics, 2010): table 11.
Life expectancy is increasing.
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Centers for Medicare & Medicaid Services (CMS)
• Who is CMS?– Administer public health care
in the U.S. – Medicare is for those 65+– Medicaid is for the indigent– CHIPS is for children– Account for 60-65% of
healthcare• Private insurance companies
– Account for 35-40%– Employer plans, etc.
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Affordable Health Care Act
• New law – Controversial– Also called “Obamacare”– TREMENDOUS impact on the U.S. Heath Care System
• Covers uninsured– Guarantees access to health care – Covers those not covered under Medicare, Medicaid,
etc.– U.S. Census: 49.9 million residents, 16.3% of the
population, were uninsured in 2010
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“…we have to pass the bill so you can find out what is in it, away from the fog of the controversy.”
--Nancy Pelosi, Member of the U.S. House of Representativesfrom California's 8th district, and Minority Leader of the U.S. House of Representatives
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Changes are Coming Due To Obamacare
• Obamacare created many new regulations; many of which are not in effect yet
• Sampling:– New 2.3% excise tax on devices– Physician Payment Sunshine Act– Health Care Exchanges
• Not fully appreciated/realized/understood in the United States yet
• Largely goes into effect this year• Huge expense to U.S. economy
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AN UPDATE + IMPORTANT CONSIDERATIONS.
FDA
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Food and Drug Administration (FDA)
• Who is the FDA?– “The FDA is a scientific
regulatory agency whose mission is to promote and protect the public health and safety of Americans. FDA’s work is a blending of science and law.” – U.S. Congress
– FDA is a giant consumer protection agency
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What products does FDA regulate?
Biologics (vaccines,
cell therapies)
Dietary Supplements
Blood, Human Cell & Tissue Products
(transplants)
Drugs (human & animal)
Medical Devices
Foods (and food additives)
CosmeticsTobacco
Radiation-Emitting Products
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Since 1975, FDA has banned the sale of small turtles (less than 4” long) due to salmonella concerns.
And let’s not forget pet turtles…
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FDA also regulates…Product supply chain
Product approvals
Manufacturing
Promotion
Certain Imports/Exports
Ingredients used
Labeling Requirements …AND MUCH MORE!
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Modern FDA structure
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The Regulatory Environment
• Heightened• Political fights• Improving…perhaps
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• “. . . Responsible for protecting the public health. . .”
It’s a balance for FDA…
“. . . advancing the public health by helping speed innovati ons . . .”
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• If it ain’t broke, don’t fix it (the system is working)– New diagnostic and treatment paradigms helped drive an increase in
U.S. life expectancy of more than 3 years, a 16% decrease in annual mortality rates, and a 25% decline in disability rates for the elderly (Makower Report)
– Mortality from heart attacks was nearly cut in half (Makower Report)– Mortality also declined by more than 30% for stroke patients and by
over 20% for those with breast cancer (Makower Report)
• Not only are we doing good for mankind, the U.S. medtech industry ships $123 billion in products, pays $21.5 billion in salaries and directly employs more than 357,000 individuals
My Soap Box
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Let’s talk about you.What is your strategic goal?
• Build a company for the long-run?• Build a company to sell?• This will impact the answers to some of the
questions coming up
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Step 1: Figure out your product. What is it?
• Drug (metabolized, systemic effect)• Device (mechanical, local effect)• Biologic (derived from living organism)• HCT/P (human cell and tissue products)• Dietary supplement (not a drug or a food)• Food • Cosmetic • None of the above? If you can’t define it, you
can’t regulate it.
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Step 2: Determine your intended use.
• This will help you answer the question on the previous slide.
• What is the product’s job? • How will you sell it?• How will physicians (or consumers) use the
product?• How does this impact reimbursement?• Will you have a disposable (if you are a device)?
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Step 3: Determine the risk of your product.
• Device– Class I (low risk)– Class II (medium risk)– Class III (high risk)
• Drug– Prescription (Rx)– Over-the-counter (OTC)
• Other products?– Biologics/biosimilars– HTC/Ps– Dietary supplements,
etc.
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Step 4: Determine your path through FDA.
• Device– Waived/exempt– 510(k)
• Rx or OTC
– PMA– De Novo
• Drug– NDA– Generic (ANDA, 505(b)
(2))
• Other products?– Biologics/biosimilars– HTC/Ps– Dietary supplements,
etc.
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Step 5: Consider the Need for Clinical Data
• You may or may not need it depending on the path you take through FDA
• What have your competitors had to do?• Will you have to submit an application for an
investigational device exemption (“IDE”) for your device?
• Will you have to submit an application for an investigational new drug (“IND”) for your drug or biologic?
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Step 6: Consider Post-Launch Responsibilities
• What can you do before launch?• Launch!• What does the Food, Drug and Cosmetic Act require you
to do? – General controls– Special controls– Post market studies and surveillance
• What other laws impact you?– Food, Drug and Cosmetic Act, Physician Payment Sunshine
Act, Anti-Kickback Statute, False Claims Act, HIPAA, state laws, etc.
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Contact info:
Copyright © 2013 DuVal & Associates, P.A. All rights reserved.
The End. Thank you! Questions?
Mark Gardner, M.B.A., [email protected]; (612) 382-7584
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Elements of a Substantial Equivalence (SE) Determination
A device is substantially equivalent if, in comparison to a predicate, if it: – has the same intended use as the predicate; and – has the same technological characteristics as the predicate;
OR – has the same intended use as the predicate; and – has different technological characteristics and the information
submitted to FDA; • does not raise new questions of safety and effectiveness; and • demonstrates that the device is at least as safe and effective as
the legally marketed device.