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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 l.jpg

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


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Basic Mission

  • Safety

  • Efficacy

    • Drugs

    • Medical Devices

  • Truthful Labeling

    • Adulteration

    • Misbranding


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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


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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


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What Does the FDA Regulate?

  • Food (with Agriculture Department)

  • Drugs

  • Biologics

  • Medical Devices

  • Cosmetics

  • Anything That Produces Dangerous Radiation

  • 25% of the Consumer Dollar


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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


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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?


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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


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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.


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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


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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


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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


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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


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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


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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


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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


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“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


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OTC Drugs

  • Labeling Is the Key

    • Directions for Safe Use

    • Recognize Complications

      • Recognize Contraindications

  • X-OTC Switch

    • Why?

    • When?


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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


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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?


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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?


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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


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