fda introduction to drug regulation l.
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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.

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fda introduction to drug regulation


Edward P. Richards

Director, Program in Law, Science, and Public Health

Louisiana State University Law Center


basic mission
Basic Mission
  • Safety
  • Efficacy
    • Drugs
    • Medical Devices
  • Truthful Labeling
    • Adulteration
    • Misbranding
fda s structure and organization
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
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
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
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
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 g8
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 g9
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
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
Getting a Drug Approved
  • Isolate or Synthesize the Agent
    • Many are Biologicals
      • Cyclosporin
      • Tamoxifen
    • Structure Activity Design
    • Genetic Engineering
  • Do Animal or in Vitro Studies to Determine Activity
  • Apply for an Investigational New Drug (Ind) Permit
clinical trials
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
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
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
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
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
“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
OTC Drugs
  • Labeling Is the Key
    • Directions for Safe Use
    • Recognize Complications
      • Recognize Contraindications
  • X-OTC Switch
    • Why?
    • When?
self treatment and care
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
controlled substances
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
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
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