INTRODUCTION TO DRUG REGULATION
Prescription Drug Regulation
Good Old Days
In the Early 1900s You Could Get Anything You
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
What Lead to the FDA?
Pediatric Elixir in Antifreeze
Crisis De Jour
What Does the FDA Regulate?
Food (also Ag Department)
Anything That Produces Dangerous Radiation
25% of the Consumer Dollar
FDA's Structure and Organization
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
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
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
Problems with Pregnant Women and Kids
No Minor Waivers
Babies As Plaintiffs
Labeled for the Physician
Physician Chooses the Drug
Physician Is Assumed to Know Pharmacology and
Must Provide All Information About Side-effects
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
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
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
III Moderate Potential for Abuse
IV Low Potential for Abuse
V Lowest Potential for Abuse
Constitutional Right to Do Dope?
Labeling Is the Key
Directions for Safe Use
Drugs for Pets
Self-treatment and Care?
Are the Vast Majority of People Prepared for
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
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?
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
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 Political Support
Who Do You Warn?
No Clear Learned Intermediary Doctrine
Some Preemption Language
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