FDA - Introduction to Drug Regulation
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Transcript FDA - Introduction to Drug Regulation
FDA - INTRODUCTION TO DRUG
REGULATION
Edward P. Richards
Director, Program in Law, Science, and
Public Health
Louisiana State University Law Center
http://biotech.law.lsu.edu
Basic Mission
Safety
Efficacy
Drugs
Medical Devices
Truthful Labeling
Adulteration
Misbranding
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
Why?
Lots of Money
Lots of Powerful Interests
Drugs, Food Labeling
Food and Drug Cranks
What Does the FDA Regulate?
Food (with Agriculture Department)
Drugs
Biologics
Medical Devices
Cosmetics
Anything That Produces Dangerous Radiation
25% of the Consumer Dollar
Food Supplements
Did Regulate Food Supplements and “Health
Foods”
Began to Crack Down on Unproven Claims and
Raise Questions about Safety
Congress was Lobbied (Oren Hatch)
Pulled the FDA Authority to Regulate Food
Supplements
Can Only Act on Evidence of Post-Marketing
Harm
No Pre-Market Approval
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.
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
Getting a Drug Approved
Isolate or Synthesize the Agent
Many are Biologicals
Structure Activity Design
Genetic Engineering
Do Animal or in Vitro Studies to Determine Activity
Apply for an Investigational New Drug (Ind) Permit
Cyclosporin
Tamoxifen
Clinical Trials
Phase I
What are the side effects?
Is it safe enough to test?
Phase II
Does it work at all?
What is the dosage range?
Phase III
Is it better than placebo?
Is it better than other treatments?
What are the side-effects
Conflicts in Clinical Trials
Life Saving Drugs
Patients want a cure
Drugs probably do not work
What if the drug is available outside the trial?
Do you quit a drug that works to get on the trial?
What if the patient Lies?
Non-Life Saving Drugs
Pay the subjects?
Docs get paid by the patient
Companies want positive results
Submit for FDA Approval
Clinical Trials Can Take Years
Very Expensive >>$100,000,000
Most Drugs are Not Approved
Labeling is Key to Approval
Narrow Use allows More Dangerous Drugs
Broader Use Means More Money
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
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?
Time
Money
FDA Does Not Regulate Physicians
Many Common Uses Are off Label
Plaintiff’s Try to Make It Negligence
OTC Drugs
Labeling Is the Key
Directions for Safe Use
Recognize Complications
Recognize Contraindications
X-OTC Switch
Why?
When?
Self-treatment and Care?
Are the Vast Majority of People Prepared for Selfmedication?
What Is the Products Liability Problem?
Labels for Idiots
Social Policy for Communicable Diseases?
Defeats the Reporting System
Improper Antibiotics Use Leads to Drugresistant Infections
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?
The Drug Lag
What Is the Drug Lag?
What Are the Conflicts?
FDA Risk Aversion?
Freedom of Choice?
What Are the Conflicting Expectations That the
FDA Faces?
Post-Market Surveillance
Clinical Trials Are Limited in Time and Scope
Many Serious Side-effects Cannot be Detected in
Trials
Dangerous to Include Pregnant Women, so no
tetragons are detected
Docs are Supposed to Report Side-effects
Not always very effective
Large Scale Trials Should Continue
Who will fund them?
Drug Companies do not want to undermine their
products