FDA History

Overview/history of the FDA

• The Food and Drug Administration (FDA) is a pivotal agency in the U.S., affecting both national and global health standards.

• Established under the 1906 Pure Food and Drugs Act, it has evolved significantly, expanding its scope to include a wide range of products.

• Key legislative milestones include the 1938 Federal Food, Drug, and Cosmetic Act and the 1962 Kefauver Harris Amendment, which required proof of efficacy and safety before drug approval.

What does adulterated means?

• Quality or purity falls below the standards set by regulatory authorities due to contamination

• Relates to composition

What does misbranded means?

• Labeling is false or misleading in any way

• Relates to information provided on the label or packaging

What is the FDA’s mission?

protecting the public health by:

1. ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation

2. regulating the manufacturing, marketing, and distribution of tobacco products

advancing the public health by:

1. helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health

significant role in the Nation's counterterrorism capability:

1. FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats

What are drugs like back in the Colonial and Pre-Civil War era?

• Drug regulation focused on trade

• Laws varied from state to state

• US became the worlds “dumping ground”

  • lack of regulation allowed for a wide variety of substances to be marketed and sold without much oversight, making the U.S. a target for both domestic and foreign drug producers

  • The Civil War resulted in numerous injuries and surgeries, leading to a heightened demand for pain relief medications. This demand was met with opiates, which were often freely distributed

• There were no labeling requirements

• Individuals were responsible for what the purchased and consumed

Aspects of 1820 - Quality Standards

• Eleven physicians meet in Washington, D.C., to establish the U.S. Pharmacopeia, the first compendium of standard drugs for the United States

• Compendial standards promote quality

  • Potency

  • Purity

  • Consistency

  • Methods for Analysis

Who is Dr. Harvey W. Wiley?

• Becomes chief chemist, expanding the Bureau of
  Chemistry's food adulteration studies

• Campaigning for a federal law

• "Crusading Chemist“

• "Father of the Pure Food and Drugs Act."

What are embalmed milk/meat?

• Watered down milk was colored with chalk or plaster and preserved with formaldehyde

• “Revived” spoiled meat

• Food dyes made with arsenic and lead ..... Used in
  candy!!!

What is the Department of Agriculture – 1860-1880?

Division of Chemistry formed and became the forerunner of the FDA

What is the Pure Food Movement?

started in 1870’s, it the General Federation of Women’s Clubs

What is the poison squad?

• Dr. Harvey Wiley – Father of the FDA

• Started testing the safety of food in humans

  • Like foods drugs had no labeling

  • Ultimately led to testing drug

Aspect of The Jungle by Upton Sinclair

Roosevelt appointed a commission to address

Aspect of the The Pure Food and Drug Act (1906)?

• Purpose: This act was the first major federal legislation aimed at regulating drugs.

• Impact: It prohibited the interstate commerce of misbranded and adulterated foods and drugs, setting a precedent for subsequent safety regulations

What is the Sherley Amendment?

• Prohibited the labeling of medicines with false therapeutic claims intended to defraud the purchasers

  • “false and fraudulent”

• The claim must be made with the intent to deceive

  • became a standard that was often difficult to prove

What happened in the Sulfanilamide Tragedy?

• Elixir of Sulfanilamide, containing the poisonous solvent diethylene glycol, kills 107 persons, many of whom are children, dramatizing the need to establish drug safety before marketing and to enact the pending food and drug law

• At the time only adulteration and mislabeling were not permitted

• Difficult to get word out to public

  • Telegrams

What are some key provisions made to the Food, Drug and Cosmetic Act of 1938?

• Required manufacturers to submit a New Drug Application (NDA) with evidence of safety before marketing, thus starting a new system of drug regulation

• Granted the FDA authority to inspect manufacturing facilities and enforce regulations

• Established guidelines for truthful labeling to protect consumers

• Eliminating the Sherley Amendment requirement to prove intent to defraud in drug misbranding cases

• Providing that safe tolerance be set for unavoidable poisonous substances

• Adding the remedy of court injunctions to the previous penalties of seizures and prosecutions

What happen in the Sulfathiazole Disaster?

• Winthrop's sulfathiazole tablets, a sulfa drug tainted with the sedative. phenobarbital

• Each sulfathiazole tablet was contaminated with about 350 mg of phenobarbital

• This incident led FDA to revise its manufacturing and quality control requirements and resulted in the set of
  regulations currently referred to as the Good Manufacturing Practices = GMPs.

What is The Durham-Humphrey Amendment?

• Purpose: Before the amendment, there was ambiguity in drug labeling and dispensing, which led to misuse and adverse effects. The legislation aimed to create a safer, more regulated system

• Significance: defines the distinction between prescription and over-the- counter (OTC) drugs enhancing drug safety

What did the FDA do in 1958?

• FDA publishes in the Federal Register the first list of substances generally recognized as safe (GRAS)

• The list contains nearly 200 substances

What happen in the Thalidomide Tragedy?

• A sedative caused severe birth defects in thousands of babies worldwide

• Dr. Kelsey at the FDA prevented its approval in the US

• Highlighted the need for efficacy testing in addition to safety testing

What is the The Kefauver-Harris Amendments?

• Requirements:

  • Mandated rigorous clinical trials to demonstrate both safety and efficacy

  • Introduced the concept of informed consent in clinical studies

  • Strengthened FDA oversight over drug advertising to ensure claims were backed by evidence

What is the Drug Efficacy Study Implementation = DESI?

• includes drugs approved by the FDA based on safety but were subsequently required to demonstrate efficacy, reviews started in 1968

• Most DESI drugs have been reviewed, and some have been withdrawn from the market due to lack of demonstrated efficacy, while others may still be available but under scrutiny

• As a pharmacist - check the latest information, the status of specific DESI drugs can change based on ongoing evaluations and regulatory decisions

What did the FDA do in 1970?

FDA requires the
first patient package insert: oral contraceptives must contain information for the patient about specific risks and benefits.

What happen in 1972?

• Over-the -Counter (OTC) drug review began to enhance the safety, effectiveness and appropriate labeling of those drugs sold without prescription

  • OTC monographs

• Regulation of Biologics - including serums, vaccines, and blood products, was transferred from the Nation Institutes of Health (NIH) to FDA

What is the Oral Anti-Tampering Act?

Tamper-resistant Packing Regulations issued by FDA to prevent poisonings such as deaths from cyanide placed in Tylenol capsules. The Federal Anti- Tampering Act passed in 1983 makes it a crime to tamper with packaged consumer products

What is the The Orphan Drug Act?

• Objective: Stimulated the development of drugs for rare diseases

• Incentives: Provided tax credits, grants, and seven years of market exclusivity, ensuring these drugs met safety and efficacy standards despite smaller patient populations

What is the The Hatch-Waxman Act?

• Purpose: Facilitated the introduction of generic drugs while maintaining incentives for innovation

• Impact: Allowed generic drugs to be approved via an Abbreviated New Drug Application (ANDA), requiring proof of bio-equivalence to brand- name drugs, ensuring safety and efficacy

What is the The Prescription Drug User fee Act = PDUFA?

• Goal: Addressed the lengthy drug approval process by allowing the FDA to collect fees from pharmaceutical companies

• Outcome: Enhanced the FDA's resources, enabling faster review times without compromising the integrity of safety and efficacy evaluations

What is the The FDA Modernization Act?

• Focus: Streamlined the drug approval process and bolstered post-marketing surveillance

• Provisions: Encouraged the use of modern technology in drug development and improved communication between the FDA and drug manufacturers, enhancing the monitoring of drug safety post-approval

Aspect of cGMPs

• Guidance for Industry: Quality Systems Approach to Pharmaceutical Current Manufacturing Practice Regulation

  • first major change to the CGMPs since 1978

  • more emphasis on new technological advances, harmonize the global quality standards, and to implement risk management into the GMP quality structure.

  • This approach enabled more widespread dissemination of CGMP information and
    provided more transparency of FDA policy concerning CGMPs.

• The FDA also published the “Physicians Labeling Rule”

  • harmonized the labeling and package insert in prescription drugs

  • made it easier for the physicians to find information about the drug

What is The Biologic Price Competition and Innovation Act = BPCIA?

• Aim: Created a regulatory pathway for biosimilars, analogous to generics for biologic drugs

• Significance: Ensured that biosimilars met rigorous standards for safety, purity, and potency, comparable to the original biologics.

What happen in 2015?

• The first Biosimilar was approved in the US

• FDA’s Office of Pharmaceutical Quality (OPQ) was established under
  CDER

  • OPQ provides assessment, inspection, research, surveillance and policy to assure that the American public has access to safe, effective, quality drugs

What is The 21st Century Cures Act?

• Objective: Accelerated the development and approval of medical innovations

• Highlights: Promoted the use of real-world evidence and adaptive
  clinical trial designs, facilitating faster access to safe and effective treatments for patients

FDA Today?

• Regulates a wide range of products, including drugs, food, cosmetics, and medical devices

• Continues to adapt to emerging challenges, such as personalized
  medicine and gene therapy

• Remains committed to its mission of protecting and promoting
  public health