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USFDA – INTRODUCTION TO DRUG REGULATION

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

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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?

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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About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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