History of Food, Drug and Cosmetics Laws

Question 0

Federal Food, Drug, and Cosmetic Act of 1938

Answer 0

Is a federal law enacted by congress. it and other federal laws establish the statutory framework within which FDA operates today. Replaced the Pure Food and Drug Act. Introduced premarket drug review.

Question 1

Pure Food and Drug Act of 1906

Answer 1

Was passed in response to demand from outrage sparked by Upton Sinclair’s The Jungle. Enforced by the Department of Agriculture’s Bureau of Chemistry. Prohibited the interstate commerce and transport of adulterated and misbranded food and drugs. Framed “intended use “ language “intended to be used for the cure, mitigation, or prevention of disease.”

Question 2

Nutrition Labeling and Education Act of 1990

Answer 2

Requires manufacturer to provide standardized food labels and consistency in health claims and serving sizes

Question 3

Bioterrorism Act of 2002

Answer 3

Prompted by 9/11 improves the ability to trace the movement of foods through international and interstate commerce, restricts the availability of certain biological agents and toxins and improves the security of the drinking water supply

Question 4

Food Allergen Labeling and Consumer Protection Act of 2004

Answer 4

a

Question 5

Color Additive Amendment of 1960

Answer 5

require manufacturers to establish the safety of color additives in foods, drugs and cosmetics and designation of colors as FD&(safe for foods, drugs and cosmetics), D&C (safe for drugs and cosmetics) or EXT. D&C(for externally applied product only)

Question 6

Kefauver-Harris Amendments of 1962

Answer 6

Mandated the establishment of efficacy as well as safety before a drug could be marketed, required FDA to assess the efficacy of drugs introduced since 1938, instituted stricter agency control over drug trials (including informed consent), transferred regulation of prescription drug advertising from FTC to FDA, established Good Manufacturing Practice (GMP)

Question 7

Controlled Substances Act of 1970

Answer 7

a

Question 8

Drug Price Competition and Patent Term Restoration Act of 1984

Answer 8

Hatch-Waxman Act - Allows the approval of drugs based upon comparison of an already approved products and exclusive marketing status for a period of time based on the length of the approval process. Authorized Abbreviated New Drug Applications (ANDAs)

Question 9

Fair Packaging and Labeling Act of 1967

Answer 9

FPLA - required products to be honestly and informatively labeled

Question 10

Prescription Drug User Fee Act of 1992

Answer 10

PDUFA - Authorized FDA to collect user fees from drug and biologics for submissions, manufacturing establishment and each prescription drug marketed. This is in exchange for performance goals.

Question 11

Food and Drug Administration Modernization Act of 1997

Answer 11

FDAMA - provided additional authority for monitoring the progress of drug and biologic postmarket studies. Required FDA to issue regulations so clinical study sponsors could modify an investigational device or study protocol by submitting a “notice of change” 5 days after instituting the change and it doesn’t affect the study design or patient safety. Directed FDA to consider the least-burdensome approach for substantial equivalence. Allowed FDA to recognize international and national standards.

Question 12

Food and Drug Administration Amendments Act of 2007

Answer 12

FDAAA - reauthorized many key programs such as PDUFA, MDUFMA and PREA. Requires all clinical trials of drugs, biologics and devices (except Phase 1) to be registered in a clinical trial databank

Question 13

Food Safety Modernization Act of 2011

Answer 13

FSMA - aims to ensure the food supply is safe by shifting focus from responding to contamination to preventing it.

Question 14

Medical Device Amendments of 1976

Answer 14

Established 3 classes of medical devices with different levels of scrutiny, up to premarket approval. The classes were based upon the degree of control necessary to assure that the devices were safe and effective. Also added device listing, establishment registration and adherence to GMPs.

Question 15

Safe Medical Devices Act of 1990

Answer 15

SMDA - device user facilities must report device related deaths to FDA and manufacturer if known. Must report injuries to manufacturer or FDA if MFG is not known. Defines a medical device

Question 16

Medical Device User Fee and Modernization Act of 2002

Answer 16

MDUFMA - established fees for premarket approval applications, supplements and 510(k) submissions. FDA committed to strict performance goals for reviews.

Question 17

Durham-Humphrey Amendment of 1951

Answer 17

Clarified what constituted a prescription vs. an over-the-counter drug.

Question 18

Orphan Drug Act of 1983

Answer 18

Affects less than 200,000 people in the US or affects more than 200k but for which there is no reasonable expectation that the cost of developing and making available in the US a drug for such disease or condition will be recovered from sales in the US. Guarantees 7 years exclusivity after approval

Question 19

Prescription Drug Amendments of 1992

Answer 19

a

Question 20

Food and Drug Administration Safety and Innovation Act of 2012

Answer 20

FDASIA - Gives FDA authority to collect user fees to fund reviews of drugs, medical devices, generic drugs and biosimilar biologics and encourages pediatric drug development

Question 21

FDA Export Reform and Enhancement Act of 1996

Answer 21

a

Question 22

Pediatric Research Equity Act of 2003

Answer 22

PREA - gave FDA authority to require pediatric studies when other approaches are insufficient to ensure safety and efficacy. FDA may waive this requirement if the diseases and effects of the treatment are sufficiently similar in adults and pediatric patients