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FDA - INTRODUCTION TO DRUG REGULATION PowerPoint Presentation

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Published on : Jul 20, 2021 | Views : 2128 | Downloads : 1

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Slide 1-

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
Slide 2-

Basic Mission Safety Efficacy Drugs Medical Devices Truthful Labeling Adulteration Misbranding
Slide 3-

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
Slide 4-

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
Slide 7-

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.
Slide 10-

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
Slide 14-

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
Slide 20-

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?
Slide 21-

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