FDA 101: Jason Sapsin

Jason Sapsin, JD, MPHJason Sapsin, JD, MPH
C.U. Graduate SchoolC.U. Graduate SchoolC.U. Graduate SchoolC.U. Graduate School
1
November 4, 2015November 4, 2015
Colorado School of PublicColorado School of Public
HealthHealth
FDA 101

• Agencies are Organisms
• Understand the genotype
• Interact and understand with whom you are interacting
• Understand the environment and the resulting “genetic
expression”

Understand the organizational culture

In 1736 I lost one of my sons, a fine boy of four
years old, by the small-pox, taken in the common
way. I long regretted bitterly, and still regret that
I had not given it to him by inoculation. This I
mention for the sake of parents who omit that
operation, on the supposition that they should
never forgive themselves if a child died under it;
my example showing that the regret may be the
same either way, and that, therefore, the safer
should be chosen . . . .

Benjamin Franklin: His Autobiography 1706-1757, Edited by
Charles WEliot Lld, P. F. Collier& Son Company, New York
(1909) TWYFORD, at the Bishop of St. Asaph's, 1771.

• FDA regulates > 20¢ of every $1 spent by U.S.
consumers
• The Agency has enforcement roots
• Has the only federal law enforcement agency exclusively
devoted to public health (OCI)
• 16, 738 total employees (FY 2015 Budget Justification)
• CDRH: 1723 CDER: 4508 ORA: 5250

Office of the CommissionerOffice of the Commissioner
Office of FoodsOffice of Foods
StructureStructure
Office of Global RegulatoryOffice of Global Regulatory
Operations and PolicyOperations and Policy
Office of MedicalOffice of Medical
Products and TobaccoProducts and Tobacco
CFSAN CDRHCBER CTPCDERCVM
ORA OCC

CFSAN ORA
OCCOF
CDER
CBER
CDRH
CVM CTP
OC
OGROPOMPT
Structure (cont’d)Structure (cont’d)

• CDRH
• CDER
• CVM
• CBER
• CFSAN
• OCC
• ORA
EnforcementEnforcement
Evaluation Offices
• CDRH
• CDER
• CVM
• CBER
• CFSAN
• OCC
• ORA
Compliance
Offices
Product DevelopmentProduct Development

1.1. ConstitutionConstitution
2.2. StatutesStatutes
(Federal Food, Drug, and Cosmetic Act)(Federal Food, Drug, and Cosmetic Act)
3.3. RegulationsRegulations
4.4. The Common LawThe Common Law
Jacobson v. MassachusettsJacobson v. Massachusetts
5. Guidance documents5. Guidance documents
6. Policy documents6. Policy documents
Places to lookforAuthority orGuidance

1. Pure Food and Drug Act (1906)
• Food and Drugs must be safe
2. Food, Drug, and Cosmetic Act of 1938
• Drugs must be proven safe
• Devices can be regulated (post-market)
3. Kefauver-Harris Amendments (1962)
• Drugs must be proven safe and effective
4. Medical Device Amendments Act (1976)
• Devices required to meet performance standards or
receive pre-market approval
Notable Statutes

Statutory example: “Device”
§201(h) (FDCA): “An instrument, apparatus, implement, machine,
contrivance . . . Including a component part, or accessory which is . . .
Intended for use in the diagnosis of disease . . . or in the cure,
mitigation, treatment or prevention of disease . . . or intended to affect
the structure or any function of the body . . . and which does not
achieve any of its primary intended purposes through chemical action
and . . . is not dependent on being metabolized.”
21 CFR §807.20: “An owner or operator who is engaged in the manufacture [etc.] of a DEVICE . . .
shall register and submit listing information for those DEVICES.”
Regulation: Registering a device

Policy example: Enforcement Policy (2010)
Guidance example: Draft Guidance – “Premarket
Notification Submissions for Medical Devices that Include
Antimicrobial Agents” (July 19, 2007)

Enforcement Philosophy:
July 15, 2010
• “One of the highest priorities”
• Some will disregard or
exercise inadequate vigilance
• Ensure firms’ investment in
quality systems
• Maintain level playing field for good
actors

Product Categories and Pathways

DrugsDrugs
Achieve effect through chemical interactionAchieve effect through chemical interaction
• OTCOTC
• RxRx
• MonographMonograph
• NDANDA
• ANDA (generic)ANDA (generic)

Drugs:Drugs:
PathwaysPathways
Monograph
“Recipe”
Ingredients
Indications
Non-Monograph
NDA
Pre-Clinical
IDE
Phased Trials
Millions x 100
10 years
ANDA
Pre-Clinical
BioE
IDE? Trial?
Millions x 10
<10 years

• Class I
• Class II
• Class III
DevicesDevices
Achieve effect through physical / mechanicalAchieve effect through physical / mechanical
interactioninteraction
No 510k*
510k
PMA

DevicesDevices
Class I & II
“510k” or “De
Novo 510k”
Substantial
Equivalence
Descriptive
and / or Trials
(IND)
Class III
PMA
IND / Trials
Safe and Effective
Class I exempt
Quality
systems
compliance
Standards
Records and
reporting

Development ConsiderationsDevelopment Considerations
• Time to marketTime to market
• IndicationsIndications
• Influence difficulty to marketInfluence difficulty to market
• Marketing implicationsMarketing implications
• Study Design / LogisticsStudy Design / Logistics
• Early engagementEarly engagement
• Informal and formal developmentInformal and formal development
approachesapproaches

Jurisdiction, Adulteration, Misbranding, Label(ing)

FDA’s po we r to re g ulate ste m s fro m Co ng re ss’
de te rm inatio n o f what co nstitute s unlawful
activity
§ 331. Prohibited acts The following acts and the causing
thereof are prohibited: (a) The introduction or delivery for
introduction into interstate commerce of any food, drug, device,
tobacco product, or cosmetic that is adulterated or misbranded.
(b) The adulteration or misbranding of any food, drug, device,
tobacco product, or cosmetic in interstate commerce. (c) The
receipt in interstate commerce of any food, drug, device,
tobacco product, or cosmetic that is adulterated or misbranded,
and the delivery or proferred delivery thereof for pay or
otherwise.

• A Strict Liability statuteA Strict Liability statute
• § 303(a): “Any person who violates a provision of§ 303(a): “Any person who violates a provision of
section 301 shall be imprisonedsection 301 shall be imprisoned for not more thanfor not more than
one year or fined not more than $1,000 or both.”one year or fined not more than $1,000 or both.”
(Misdemeanor)(Misdemeanor)
• § 305: Notice and opportunity to present views§ 305: Notice and opportunity to present views
prior to reporting to DOJprior to reporting to DOJ

Park DoctrinePark Doctrine
““A positive duty to seek out and remedyA positive duty to seek out and remedy
violations when they occur, but also,violations when they occur, but also,
andand primarily, a duty to implementprimarily, a duty to implement
measures that will insure that violationsmeasures that will insure that violations
will not occurwill not occur.”.”
SCOTUS 1975SCOTUS 1975

FDAFDA
• AdulterationAdulteration
Product is not what it appears to be in quality, purity or natureProduct is not what it appears to be in quality, purity or nature
• MisbrandingMisbranding
Product is not what it is implicitly or explicitly represented to beProduct is not what it is implicitly or explicitly represented to be

• Adulteration (Drugs and Devices §351)
Insanitary conditions; improper conditions of manufacture,
packing or storage; does not meet performance standards; it
lacks premarket approval; it is used outside its investigational
exemption
• Misbranding (Drugs and Devices §352)
Labeling is false or misleading in any particular; lack of
prominence or conspicuousness; failure to report or conduct
postmarket surveillance; failure to identify the manufacturer
• Label /Labeling (§321)
“Label” is printed, written or graphic matter on the immediate
container; “Labeling” is both labels and other written, printed or
graphic matter on the article, its containers or accompanying
the article.

ConsequencesConsequences
• FinesFines
• Jail time (limited)Jail time (limited)
• DebarmentDebarment
• Subsequent exposure to felonySubsequent exposure to felony
prosecutionprosecution
Park DoctrinePark Doctrine

Common Mistakes
1.Failure to communicate / failure to build
relationships
2.Related: Shortcuts & “Adversarialism”
3.Underestimating FDA reviewers / Inspectors
4.Misunderstanding FDA’s population-level
(public health) focus

Common MisperceptionsCommon Misperceptions
1.1. FDA is slower to approve new drugs than EU?FDA is slower to approve new drugs than EU?
2. Average (actual) time to final decision for 510ks is2. Average (actual) time to final decision for 510ks is
1-2 years?1-2 years?
3. Average (actual) time to final decision for PMAs is3. Average (actual) time to final decision for PMAs is
3-5 years?3-5 years?

Exercise
1. You have an opportunity to join a new company. You will either
be pursuing a new medical device or a new drug. The device is
a variation of an existing medical device; the drug is based on a
known drug but with different indications and a new delivery
system. Which do you pursue, and why?
2. In developing your product, the CEO suggests that you see how
it performs with some of the patients who you – as a new,
practicing physician – regularly see. These patients suffer from
very difficult conditions and you think the new therapies could
help them. What do you do? Why?
3. Your new product is about to go to market. The Chief Operating
Officer tells you that there is a deviation from specification (non
life-threatening) in some of the products, occurring very rarely.
QA has only found one problem in a run of 20,000 units and it
appears to be random. The products are being loaded off the
shipping dock.

THE ENDTHE END

FDA 101: Jason Sapsin

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