Second Set: 1900s

Question 1

What is the Biologies Control Act?

Answer 1

passed in 1902 to ensure purity and safety of serums, vaccines, and similar products used to prevent or treat diseases in humans.

Question 2

When does Samuel Hopkins Adams’ ten-part expose of the patent medicine industry, “The Great American Fraud,” begins in Collier’s begin?

Answer 2

1905

Question 3

In 1905, _______________ initiates a voluntary program of drug approval that would last until 1955.

Answer 3

The American Medical Association.

(To earn the right to advertise in AMA and related journals, companies submitted evidence, for review by the Council and outside experts, to support their therapeutic claims for drugs)

Question 4

When and who passes the original FDA?

Answer 4

1906 by Congress (June 30) and Roosevelt.

It prohibits interstate commerce in misbranded and adulterated foods, drinks and drugs.

Question 5

U.S. v Johnson

Answer 5

1911; Supreme Court rules that the 1906 Food and Drugs Act does not prohibit false therapeutic claims but only false and misleading statements about the ingredients or identity of a drug.

Question 6

Sherley Amendment

Answer 6

1912; Congress overrules US v Johnson

(It prohibits labeling medicines with false therapeutic claims intended to defraud the purchaser, a standard difficult to prove.)

Question 7

Harrison Narcotic Act

Answer 7

1914; requires prescriptions for products exceeding the allowable limit of narcotics and mandates increased record-keeping for physicians and pharmacists who dispense narcotics.

Question 8

The Food, Drug, and Insecticide Administration is shortened to?

Answer 8

The FDA in 1930

Question 9

Prescription drug broadcast advertising

Answer 9

1999; published to ensure consumers get a balanced view of the benefits and risks of a product.

Question 10

Managing the Risks from Medical Product Use: Creating a Risk Management Framework.

Answer 10

1999; The report describes current and recommended premarket and postmarket risk assessment procedures and the need for better risk communications.

Question 11

ClinicalTrials.gov

Answer 11

1999; founded to provide the public with updated information on enrollment in federally and privately supported clinical research, thereby expanding patient access to studies of promising therapies.

FDA publishes guidances for electronic submissions that provide for the receipt and archiving of a new drug application entirely in electronic format without an accompanying paper archival copy.

A final rule mandates that all over-the-counter drug labels must contain data in a standardized format. These drug facts are designed to provide the patient with easy-to- find information, analogous to the nutrition facts label for foods.

Question 12

Pediatric Rule

Answer 12

1998; Requires manufacturers of selected new and existing drug and biological products to conduct studies to assess their safety and efficacy in children

Question 13

Thalidomide

Answer 13

1998; FDA approves the use of thalidomide for the treatment of Hansen’s Disease, commonly known as leprosy. In tandem with the approval FDA invokes an oversight program designed to help ensure a zero tolerance policy for thalidomide exposure during pregnancy.

Question 14

Demographic Rule

Answer 14

1998; requires that a marketing application analyze data on safety and effectiveness by age, gender, and race.

Question 15

Adverse Event Reporting System (AERS)

Answer 15

1998; computerized information database designed to support the FDA’s post-marketing safety surveillance program for approved drug and therapeutic biologic products. The ultimate goal of AERS is to improve the public health by providing the best available tools for storing and analyzing safety reports.

Question 16

Food and Drug Administration Modernization Act (FDAMA)

Answer 16

1997; reauthorizes the Prescription Drug User Fee Act of 1992 and mandates the most wide-ranging reforms in agency practices since 1938. Provisions include measures to accelerate review of devices, regulate advertising of unapproved uses of approved drugs and devices, and regulate health claims for foods.

Question 17

Cigarettes

Answer 17

1995; FDA declares cigarettes to be “drug delivery devices.” Restrictions are proposed on marketing and sales to reduce smoking by young people.

Question 18

Uruguay Round Agreements Act

Answer 18

1994; extends the patent terms of U.S. drugs from 17 to 20 years.

Question 19

MedWatch

Answer 19

1993; A consolidation of several adverse reaction reporting systems. designed for voluntary reporting of problems associated with medical products to be filed with FDA by health professionals.

Question 20

FDA issues guidelines calling for improved assessments of medication responses as a function of gender in 1993.

Answer 20

Revising a policy from 1977 that excluded women of childbearing potential from early drug studies. Companies are encouraged to include patients of both sexes in their investigations of drugs and to analyze any gender-specific phenomena.

Question 21

Prescription Drug User Fee Act (PDUFA)

Answer 21

1992; requires drug and biologics manufacturers to pay fees for product applications and supplements, and other services. The act also requires FDA to use these funds to hire more reviewers to assess applications.

Question 22

International Conference on Harmonization (ICH)

Answer 22

1992; The U.S. FDA with Japan and Europe establish the International Conference on Harmonization (ICH). The ICH works to reduce the burden of regulation by harmonizing regulatory requirements in the three regions.

Question 23

Generic Drug Enforcement Act

Answer 23

1992; imposes debarment and other penalties for illegal acts involving abbreviated drug applications.

Question 24

Common Rule

Answer 24

The policy for protection of human subjects in research, promulgated in 1981 by FDA and the Department of Health and Human Services, is adopted by more than a dozen federal entities involved in human subject research

This rule issues requirements for researchers who obtain and document informed consent, secures special protection for children, women, and prisoners, elaborates on required procedures for institutional review boards, and ensures that research institutions comply with the regulations.

Question 25

Accelerate the Review of Drugs

Answer 25

1991 Regulations published to Accelerate the Review of Drugs for life-threatening diseases

Question 26

Elderly People in clinical studies

Answer 26

1989;The FDA issued guidelines asking manufacturers to determine whether a drug is likely to have significant use in elderly people and to include elderly patients in clinical studies if applicable.

Question 27

Prescription Drug Marketing Act

Answer 27

1988; bans the diversion of prescription drugs from legitimate commercial channels. Congress finds that the resale of such drugs leads to the distribution of mislabeled, adulterated, subpotent, and counterfeit drugs to the public. The new law requires drug wholesalers to be licensed by the states; restricts reimportation from other countries; and bans sale, trade or purchase of drug samples, and traffic or counterfeiting of redeemable drug coupons.

Question 28

Food and Drug Administration Act

Answer 28

Food and Drug Administration Act of 1988 officially establishes FDA as an agency of the Department of Health and Human Services with a Commissioner of Food and Drugs appointed by the President with the advice and consent of the Senate, and broadly spells out the responsibilities of the Secretary and the Commissioner for research, enforcement, education, and information.

Question 29

Investigational drug regulations

Answer 29

1987; revised to expand access to experimental drugs for patients with serious diseases with no alternative therapies.

Question 30

Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act)

Answer 30

1984; expedites the availability of less costly generic drugs by permitting FDA to approve applications to market generic versions of brand-name drugs without repeating the research done to prove them safe and effective. At the same time, the brand-name companies can apply for up to five years additional patent protection for the new medicines they developed to make up for time lost while their products were going through FDA’s approval process.

Question 31

Orphan Drug Act

Answer 31

1983; enabling FDA to promote research and marketing of drugs needed for treating rare diseases.

Question 32

first televised advertisement for a prescription drug

Answer 32

1983; purportedly for price comparison with a competitor’s product, but it includes information about therapeutic indication and relative value of the advertised drug-without summarized information about side effects. The same year, FDA initiates a voluntary moratorium on direct-to-consumer advertising of prescription drugs to study the issue among consumers, health professionals, and industry. FDA withdrew the moratorium in 1985.

Question 33

Tamper-resistant Packaging Regulations

Answer 33

1982; 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.

Question 34

regulations for human subject protections

Answer 34

1981; FDA and the Department of Health and Human Services revise regulations for human subject protections, based on the 1979 Belmont Report, which had been issued by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The revised rules provide for wider representation on institutional review boards and they detail elements of what constitutes informed consent, among other provisions.

Question 35

regulations for human subject protections

Answer 35

1981; FDA and the Department of Health and Human Services revise regulations for human subject protections, based on the 1979 Belmont Report, which had been issued by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The revised rules provide for wider representation on institutional review boards and they detail elements of what constitutes informed consent, among other provisions.

Question 36

Bioresearch Monitoring Program

Answer 36

1977; an agency-wide initiative ensures the quality and integrity of data submitted to FDA and provides for the protection of human subjects in clinical trials by focusing on preclinical studies on animals, clinical investigations, and the work of institutional review boards.

Question 37

Vitamins and Minerals Amendments (“Proxmire Amendments”)

Answer 37

1976; stop FDA from establishing standards limiting potency of vitamins and minerals in food supplements or regulating them as drugs based solely on potency.

Question 38

In 1973, The Supreme Court upholds…..

Answer 38

the 1962 drug effectiveness law and endorses FDA action to control entire classes of products by regulations rather than to rely only on time- consuming litigation.

Question 39

Over-the-Counter Drug Review

Answer 39

1972; begun to enhance the safety, effectiveness and appropriate labeling of drugs sold without prescription.

Question 40

Comprehensive Drug Abuse Prevention and Control Act

Answer 40

1970; previous laws and categorizes drugs based on abuse and addiction potential compared to their therapeutic value.

Question 41

Upjohn v. Finch

Answer 41

1970; Court of Appeals upholds enforcement of the 1962 drug effectiveness amendments by ruling that commercial success alone does not constitute substantial evidence of drug safety and efficacy.

Question 42

When did the FDA require the first patient package insert oral contraceptives must contain information for the patient about specific risks and benefits?

Answer 42

1970

Question 43

Drug Efficacy Study Implementation (DESI)

Answer 43

1969; to implement recommendations of the National Academy of Sciences investigation of effectiveness of drugs first marketed between 1938 and 1962.

Question 44

Fair Packaging and Labeling Act

Answer 44

1966; requires all consumer products in interstate commerce to be honestly and informatively labeled, with FDA enforcing provisions on foods, drugs, cosmetics, and medical devices.

Question 45

FDA contracts with the National Academy of Sciences/National Research Council in 1966 to do what?

Answer 45

evaluate the effectiveness of 4,000 drugs approved on the basis of safety alone between 1938 and 1962

Question 46

Drug Abuse Control Amendments

Answer 46

1965; are enacted to deal with problems caused by abuse of depressants, stimulants, and hallucinogens.

Question 47

Advisory Committee on Investigational Drugs

Answer 47

1963; the first meeting of a committee to advise FDA on product approval and policy on an ongoing basis.

Question 48

Kefauver-Harris Drug Amendments

Answer 48

1962; For the first time, drug manufacturers are required to prove to FDA the effectiveness of their products before marketing them.

Question 49

Thalidomide

Answer 49

1962; a new sleeping pill, is found to have caused birth defects in thousands of babies born in Western Europe. News reports on the role of Dr. Frances Kelsey, FDA medical officer, in keeping the drug off the U.S. market, arouse public support for stronger drug regulation.

Question 50

Hepasyn

Answer 50

1955; FDA denies a new drug application for a cancer drug, on the grounds that it was not proven safe because it was not proven effective, an important consideration for a serious disease in which other useful therapies existed.

In 1961 the agency was challenged in a hearing over the same issue involving an antiinfective drug, Altafur, which was decided in FDA’s favor.

Question 51

Factory Inspection Amendment

Answer 51

1953; clarifies previous law and requires FDA to give manufacturers written reports of conditions observed during inspections and analyses of factory samples.

Question 52

U.S. v. Cardiff

Answer 52

1952; Supreme Court rules that the factory inspection provision of the 1938 FDC Act is too vague to be enforced as criminal law.

A nationwide investigation by FDA reveals that chloramphenicol, a broad-spectrum antibiotic, has caused nearly 180 cases of often fatal blood diseases. Two years later FDA would engage the American Society of Hospital Pharmacists, the American Association of Medical Record Librarians, and later the American Medical Association in a voluntary program of drug reaction reporting.

Question 53

Durham-Humphrey Amendment

Answer 53

1951; defines the kinds of drugs that cannot be used safely without medical supervision and restricts their sale to prescription by a licensed practitioner.

Question 54

Alberty Food Products Co. v. U.S

Answer 54

1950; a court of appeals rules that the directions for use on a drug label must include the purpose for which the drug is offered. Therefore, a worthless remedy cannot escape the law by not stating the condition it is supposed to treat.

Question 55

U. S. v. Sullivan

Answer 55

1948; FDA’s jurisdiction extends to the retail distribution, thereby permitting FDA to interdict in pharmacies illegal sales of drugs–the most problematical being barbiturates and amphetamines.

Question 56

Penicillin Amendment

Answer 56

1945; requires FDA testing and certification of safety and effectiveness of all penicillin products. Later amendments would extend this requirement to all antibiotics. In 1983 such control would be found no longer needed and abolished

Question 57

Insulin Amendment

Answer 57

1941; requires FDA to test and certify purity and potency of this lifesaving drug for diabetes.

Nearly 300 deaths and injuries result from distribution of sulfathiazole tablets tainted with the sedative, phenobarbital. The incident prompts FDA to revise manufacturing and quality controls drastically, the beginning of what would later be called good manufacturing practices (GMPs).

Question 58

Wheeler-Lea Act

Answer 58

1938; the Federal Trade Commission is charged with overseeing advertising associated with products otherwise regulated by FDA, with the exception of prescription drugs.

Question 59

Federal Food, Drug, and Cosmetic (FDC) Act

Answer 59

1938; passed by Congress, containing new provisions

Extending control to cosmetics and therapeutic devices.
Requiring new drugs to be shown safe before marketing, starting a new system of drug regulation.
Eliminating the Sherley Amendment requirement to prove intent to defraud in drug misbranding cases.
Providing that safe tolerances be set for unavoidable poisonous substances.
Authorizing standards of identity, quality, and fill-of-container for foods.
Authorizing factory inspections.
Adding the remedy of court injunctions to the previous penalties of seizures and prosecutions.

Question 60

Requirement for prescription only (non-narcotic) drugs.

Answer 60

1938; FDA says that sulfanilamide and selected other dangerous drugs must be administered under the direction of a qualified expert

Question 61

Elixir Sulfanilamide

Answer 61

1937; 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.

Question 62

1906 Food and Drugs Act

Answer 62

1933; FDA recommends a complete revision of the obsolete 1906 Food and Drugs Act. The first bill is introduced into the Senate, launching a five-year legislative battle.

FDA assembles a graphic display of shortcomings in pharmaceutical and other regulation under the 1906 act. Dubbed by one reporter as the Chamber of Horrors, the display is exhibited nationwide to help draw support for a new law.