1

REG 101FDA Overview

Jason W. Sapsin, JD, MPH

REG 101 June 25, 2015

June 25, 2015

IMDMC REG 101

• Agency Perspective

• Agency Structure

• Sources of Authority (Tools)

• Foundational Concepts

REG 101

Agency Perspective

June 25, 2015

IMDMC REG 101

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 . . . .

June 25, 2015

IMDMC REG 101

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

June 25, 2015

IMDMC REG 101

June 25, 2015

IMDMC REG 101

June 25, 2015

IMDMC REG 101

REG 101

Agency Structure

June 25, 2015

IMDMC REG 101

• 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: 1,723• ORA: 5,250• CDER: 4,508

• 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: 1,723• ORA: 5,250• CDER: 4,508

FDA Organization and Stats

June 25, 2015

IMDMC REG 101

Office of the Commissioner

Office of Foods and Vet Med

Office of Global Regulatory Operations and PolicyOffice of Medical Products and Tobacco

CFSAN CDRHCBER CTPCDERCVM

ORA OCC

FDA Structure

June 25, 2015

IMDMC REG 101

CFSANORA

OCCOF

CDER

CBER

CDRHCVM CTP

OC

OGROPOMPT

FDA Structure (cont’d)

June 25, 2015

IMDMC REG 101

““Two Halves”Two Halves”

• CDRH• CDER• CVM• CBER• CFSAN

• OCC• ORA

EnforcementEnforcement

Evaluation Offices

• CDRH• CDER• CVM• CBER• CFSAN

• OCC• ORA

Compliance Offices

Product DevelopmentProduct Development

June 25, 2015

IMDMC REG 101

Facilities

June 25, 2015

IMDMC REG 101

CDRH Offices

• Office of the Center Director (Jeff Shuren, JD, MD)

• Office of Device Evaluation (Bill Meisel, MD, MPH)

• Office of Compliance (Jan Welch (acting))

• Office of IVD / RH (Alberto Gutierrez, PhD)

• Office of Surveil. and Biom. (Tom Gross, MD, MPH)

• Office of the Center Director (Jeff Shuren, JD, MD)

• Office of Device Evaluation (Bill Meisel, MD, MPH)

• Office of Compliance (Jan Welch (acting))

• Office of IVD / RH (Alberto Gutierrez, PhD)

• Office of Surveil. and Biom. (Tom Gross, MD, MPH)

June 25, 2015

IMDMC REG 101

June 25, 2015

IMDMC REG 101

Enforcement Metrics

REG 101

Sources of Authority

June 25, 2015

IMDMC REG 101

Places to look for Authority or Guidance

1. Constitution2. Statutes

(Federal Food, Drug, and Cosmetic Act)3. The Common Law4. Regulations5. Guidance documents6. Policy documents

June 25, 2015

IMDMC REG 101

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

June 25, 2015

IMDMC REG 101

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

June 25, 2015

IMDMC REG 101

Policy example: Enforcement Policy (2010)

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

June 25, 2015

IMDMC REG 101

“In today’s rapidly changing environment, complacency is not an option. . . . I do predict more action. Tell your clients and companies to get going.”

Deborah Autor, FDA, CDER, Director of Compliance Office, May 2009

Policy Example

June 25, 2015

IMDMC REG 101

“The traditional tools of a regulatory agency are regulation, approval or disapproval of applications, and enforcement . . . . The FDA's job is to minimize risks through education, regulation, and enforcement.”

FDA Commissioner Margaret Hamburg, New England Journal of Medicine, June 11, 2009

Policy Example

June 25, 2015

IMDMC REG 101

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 good actors

REG 101

Foundational Concepts

Jurisdiction, Adulteration, Misbranding, Label(ing)

June 25, 2015

IMDMC REG 101

Number 1 conceptNumber 1 conceptFDA’s power to regulate stems from

Congress’ determination of what constitutes 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.

June 25, 2015

IMDMC REG 101

Adulteration and MisbrandingAdulteration and Misbranding

• 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.

31

REG 101FDA Overview

Jason W. Sapsin, JD, MPH

REG 101 June 25, 2015

Thank you!Thank you!