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Table of Contents





Prescription Drug Regulation

Good Old Days

 In the Early 1900s You Could Get Anything You Wanted

 No Concern for People Poisoning Themselves

 Few Effective Drugs

 Limited Rationale for Physician Supervision

 Harrison Narcotics Act

 Heroin Was the Hero Drug Because It Saved People From Morphine

What Lead to the FDA?

 The Jungle

 Pediatric Elixir in Antifreeze

 Reefer Madness

 Crisis De Jour

Basic Mission




 Medical Devices

 Truthful Labeling



What Does the FDA Regulate?

 Food (also Ag Department)



 Medical Devices


 Anything That Produces Dangerous Radiation

 25% of the Consumer Dollar

FDA's Structure and Organization

 The Commissioner

 President Appoints, Senate Confirms

 4th Tier in HHS

 Not an Independent Agency

 Insulation From Politics (Old Days)

 Few Political Appointees

 Scientific Basis of Its Decisions

 Visibility Protects It From Presidential Pressure

Does Congress Defer to the FDA?

 No, Congress Constantly Reviews the Agency in Committee Meetings


 Lots of Money

 Lots of Powerful Interests

 Drugs, Food Labeling

 Food and Drug Cranks

What Is a Drug? 201(g)

 (A) Articles Recognized in the Official United States Pharmacopoeia, Official Homeopathic Pharmacopoeia of the United States, or Official National Formulary, or Any Supplement to Any of Them

 Does the FDA Really Treat Every Thing in These As Drugs?

What Is a Drug? 201(g)

(B) Articles Intended for Use in the Diagnosis, Cure, Mitigation, Treatment, or Prevention of Disease in Man or Other Animals

 How Do You Judge This?

 Manufacturer or Seller's Representations

 Are These Limited to Labels and Advertising?

 No, Sec Info Is an Example

 Can Consider Consumer Expectations in Exceptional Circumstances

What Is a Drug? 201(g)

 (C) Articles (Other Than Food) Intended to Affect the Structure or Any Function of the Body of Man or Other Animals

 Do They Really Mean This? (Guns, Bullets)

 (D) Articles Intended for Use As a Component of Any Article Specified in Clauses (A), (B), or (C) of This Paragraph.

Getting a Drug Approved

 Isolate or Synthesize the Agent

 Do Animal Studies to Determine Activity

 Investigational New Drug (IND) Permit

 Do Clinical Trials and Final Approval

 Takes Years


 Problems with Pregnant Women and Kids

 No Minor Waivers

 Babies As Plaintiffs

Modern Labeling

 Labeled for the Physician

 Physician Chooses the Drug

 Physician Is Assumed to Know Pharmacology and Therapeutics

 Must Provide All Information About Side-effects and Contraindications

 Origin of the Learned Intermediary

 Huge Issue When States Allow Non-physicians to Prescribe Drugs

Labeling and Promotion

 Label Limited to Proven Efficacy

 Until Recently, Promotions Limited to Proven Efficacy

 What Is the PDR?

 Private Listing of Drug Info and Promotions

 Info Provided in the PDR in a Label

 Must Be the Same As the Package Insert

"Off Label" Use

 Any Use That Is Not FDA Approved

 Why Not Get Approval?



 FDA Does Not Regulate Physicians

 Many Common Uses Are off Label

 Plaintiff's Try to Make It Negligence

Controlled Substances

Drug Enforcement Administration (DEA)

 What Are the 5 Schedules?

 I High Potential for Abuse and No Currently Accepted Medical Use (in the Us) - Heroin

 II High Potential for Abuse but a Medical Use

 III Moderate Potential for Abuse

 IV Low Potential for Abuse

 V Lowest Potential for Abuse

 Constitutional Right to Do Dope?

OTC Drugs

 Labeling Is the Key

 Directions for Safe Use

 Recognize Complications

 Recognize Contraindications

RX-OTC Switch



 Drugs for Pets

Self-treatment and Care?

 Are the Vast Majority of People Prepared for Self-medication?

 What Is the Products Liability Problem?

 Labels for Idiots

 Social Policy for Communicable Diseases?

 Defeats the Reporting System

 Improper Antibiotics Use Leads to Drug-resistant Infections

 Direct Promotion to Consumers

The Drug Lag

 What Is the Drug Lag?

 What Are the Conflicts?


 AIDS Conspiracy Theory

 FDA Risk Aversion?

 Freedom of Choice?

 What Are the Conflicting Expectations That the FDA Faces?

Medical Devices

 FDA Regulated Devices From the Beginning

 Original Law Required Proof of Harm

 Could Tie the FDA Up in Court for Years

 No Regulation of Efficacy

 Safety Only As Regards Direct Hazard

 No Consideration of Danger of Improper Treatment

Expanding The FDA's Role

 Congressional Hearings on Medical Devices


 Anesthesia Machines

 An Integral Part of Modern Medicine

 Post-WW II Expansion of Technology

 Necessary For ICU and Specialty Surgery

 Congress Decides to Regulate Devices

MDA of 1976

 Medical Device Amendments of 1976

 Grand-fathered in pre-existing Devices

 Established Risk Classes

 Class I - Low Risk

 Class II - Moderate Risk

 Class III - High Risk

 FDA Was To Evaluate Existing Devices

 No Money

 No Political Support

Legal Issues

 Classic Products

 Who Do You Warn?

 No Clear Learned Intermediary Doctrine

 Some Preemption Language

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