1951 Durham-Humphrey Amendment: FDA Regulations Quiz and Flashcards

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Questions and Answers

What is the other name for the Pure Food and Drug Act of 1906?

Sulfanilamide Tragedy

Kefauver-Harris Amendment

Wiley-Heyburn Act (correct)

Durham-Humphrey Amendment

Which tragedy prompted the passing of the Food, Drug, and Cosmetic Act of 1938?

Sulfanilamide Tragedy (correct)

Waxman-Hatch Amendment

Thalidomide Disaster

Kefauver-Harris Amendment

What did the Kefauver-Harris Amendment of 1962 strengthen?

New Drug Approval Process (correct)

Patent Term Restoration

Food and Drug Administration (FDA)

Department of Health and Human Services (DHHS)

Under what condition does a drug qualify as an orphan drug?

Treating diseases/conditions affecting fewer than 200,000 Americans Signup and view all the answers

What is one purpose of an Investigational New Drug (IND)?

To protect the safety of humans in clinical trials Signup and view all the answers

What does the FDCA require independent investigators to secure for the administration of an experimental drug in all 3 phases of clinical trials?

Informed consent from patients Signup and view all the answers

Under postmarketing surveillance, what is one of the five things that the manufacturer must submit to the FDA?

Quantity of drug distributed Signup and view all the answers

What authority did FDAAA grant the FDA regarding prescription drugs?

Authority to require phase 4 testing Signup and view all the answers

Which is not a requirment for a patient to request an investigational drug from the manufacturer?

The patient must be over 18 years old Signup and view all the answers

What is the purpose of an Emergency Use Authorization (EUA) according to the text?

To facilitate the availability and use of medical countermeasures during public health emergencies Signup and view all the answers

What expectations does the FDA have of manufacturers submitting Emergency Use Authorizations (EUAs)?

Providing phase 1 and 2 trial data in the EUA submission Signup and view all the answers

What are the two main requirements that an Abbreviated New Drug Application (ANDA) must demonstrate?

Bioequivalence and acceptable manufacturing methods and controls Signup and view all the answers

What does a Type 1 chemical classification of a new drug indicate?

New molecular entity Signup and view all the answers

What does the NDC number's first section identify?

The manufacturer Signup and view all the answers

What does the imprint code on solid dosage forms indicate?

Manufacturer and specific drug product Signup and view all the answers

How often are manufacturers inspected by the FDA for compliance with CGMP?

Once every 2 years Signup and view all the answers

What do Current Good Manufacturing Practices (CGMP) not regulate?

Advertising the drug Signup and view all the answers

Who conducts phase 2 clinical trials according?

The sponsoring company Signup and view all the answers

What is one aim of phase 1 clinical trials?

Determine suitable dosage levels for the drug Signup and view all the answers

In phase 2 clinical trials, who are the subjects typically composed of according to the text?

Individuals with the same disease as the drug is intended for Signup and view all the answers

What action can be taken if the FDA does not reject an IND request within 30 days of submission based on the text?

Human clinical testing may begin Signup and view all the answers

Which act created the elimination of certain labeling requirements, such as changing 'caution: Federal law prohibits dispensing without a prescription' to 'RX only'?

Food and Drug Administration Modernization Act of 1997 Signup and view all the answers

What was the primary motivation behind the passage of the Pure Food and Drug Act of 1906?

Preventing adulteration and misbranding of food and drugs Signup and view all the answers

Which was NOT was a significant provision to the Food and Drug Administration Modernization Act of 1997?

Additional compulsary labeling requirements Signup and view all the answers

What was one effect of the Durham-Humphrey Amendment of 1951?

Establishing two classes of drugs (OTC vs. Prescription) Signup and view all the answers

What does the second section of the NDC number identify?

Product strength, dosage form, and formulation Signup and view all the answers

What is the significance of the imprint code found on solid dosage forms?

It identifies the manufacturer and specific drug product Signup and view all the answers

What does 'Adulteration' in relation to a drug refer to?

Drug composition Signup and view all the answers

What is meant by the third section of the NDC number?

Package size and type Signup and view all the answers

'Misbranding' in relation to a drug refers to what aspect?

Drug labeling Signup and view all the answers

The FDA requires that manufacturers imprint solid dosage forms, whether they are rx or nonrx products.

True Signup and view all the answers

Study Notes

Clinical Trials and FDA Regulations

In all 3 phases of clinical trials, the FDCA requires independent investigators to secure informed consent from patients for the administration of an experimental drug.

Informed consent is required from patients for the administration of an experimental drug.
Under postmarketing surveillance, the manufacturer must submit 5 things to the FDA, including:
- Reports of serious adverse events (AEs)
- New information related to the drug's safety and efficacy
- Information about current clinical studies
- Quantity of drug distributed
- Information about labeling and advertising

FDA Monitoring of Approved Drugs

The FDA monitors drugs after approval through postmarketing surveillance.
The FDA has the authority to require phase 4 testing for any prescription drug under the FDAAA (FDA Amendments Act of 2007).

Access to Investigational Drugs

Widespread access allows the provision of investigational drugs outside controlled clinical trials to treat patients with serious or immediately life-threatening diseases for which no comparable or satisfactory therapy is available.
An individual patient, acting through a physician, may request an investigational drug from the manufacturer under certain circumstances, including:
- The physician determines that the patient has no comparable or satisfactory alternative therapy and that the risk to the patient from the drug is no greater than the risk from the disease or condition.
- The FDA determines that there is enough evidence of safety and efficacy to support use and that the use of the drug will not interfere with clinical investigations in support of marketing approval.

Emergency Use Authorization (EUA)

An EUA is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies.
An EUA does not constitute the approval of the drug in the full statutory meaning of the term but instead authorizes the FDA to facilitate the availability of an unapproved product.

FDA Expectations Following EUAs

The FDA has certain expectations of manufacturers following EUAs, including the submission of all data from phase 1 and 2 trials, and phase 3 data with a median follow-up of at least 2 months after completion of the full regimen.

Types of NDA Submissions

An Abbreviated New Drug Application (ANDA) must demonstrate bioequivalence and acceptable manufacturing methods and controls.
A Type 1 chemical classification of a new drug indicates a new molecular entity.
A Type 6 chemical classification of a new drug indicates a new therapeutic indication for a drug already approved.
A Type P (Priority) indicates that the drug represents a major therapeutic gain because there are no other effective drugs available for treating a particular illness or because it has significant advantages compared to currently marketed drugs.
A Type S (Standard) indicates that the drug is similar to other drugs on the market.

Advertising and Labeling Regulations

Nonprescription drug product advertising is regulated by the Federal Trade Commission (FTC).
There are no federal regulations that address direct-to-consumer prescription drug advertising.
The National Drug Code (NDC) is a numbering system that aids in identifying a drug product, and is required for prescription and OTC drugs.
The FDA is responsible for administering the Food, Drug, and Cosmetic Act (FDCA).

History of FDA Regulations

The Pure Food and Drug Act of 1906 prohibited adulteration and misbranding of food and drugs in interstate commerce.
The Food, Drug, and Cosmetic Act of 1938 (FDCA) was prompted by the sulfanilamide tragedy and stated that no new drug could be marketed until proven safe for use.
The Durham-Humphrey Amendment of 1951 established two classes of drugs (OTC vs. Prescription).
The Kefauver-Harris Amendment of 1962 strengthened the new drug approval process by requiring that drugs be proven safe and effective.
The Orphan Drug Act of 1983 qualified drugs for rare diseases or conditions affecting fewer than 200,000 Americans.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Waxman-Hatch Amendment) allowed companies to submit an ANDA for approval of generic products and established patent-term extensions or market exclusivity for 2-5 years, depending on the regulatory review of the drug.

FDA Modernization Act of 1997

The FDAMA created provisions for pharmacy compounding, expediting study and approval of fast-track drugs, elimination of certain labeling requirements, dissemination of off-label treatment information, and encouragement of pediatric studies.
The act eliminated the " Rx only" label, replacing it with "Caution: Federal law prohibits dispensing without a prescription."

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Test your knowledge on the regulations surrounding independent investigators, informed consent, NDA submissions, and postmarketing surveillance in clinical trials. Includes questions on patient administration, drug merit evaluation, and FDA reporting requirements.

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