USFDA – INTRODUCTION TO DRUG REGULATION
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?
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
(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 like- 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
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
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
RX-OTC Switch
- Why?
- When?
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
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
Referance;- PPT by Edward P. Richards
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