Federal Acts

Question 1

Pure Food and Drug Act 1906

Answer 1

• Prohibits misbranded and adulterated foods and drugs from being distributed through interstate commerce.
• Misbranding provision prevents false claims of drug strength, quality, and purity but NOT EFFICACY.

Question 2

1912 Amendment to Pure Food and Drug Act 1906

Answer 2

Amended misbranding provision to prohibit false claims on efficacy (but difficult to enforce).

Question 3

Food, Drug, and Cosmetic Act (FDCA) 1938

Answer 3

• Requires any new drug could not be marketed until that drug was proven safe when used according to directions on the label.
• Requires drug labels to include adequate directions for use and warnings about habit forming drugs contained in the product.
• Expanded definition of adulterated and misbranded.
• Law includes food, drugs, cosmetics, and medical devices.
• Drugs before 1938 were grandfathered in, exempted from proven safe.

Question 4

Durham-Humphrey Amendment 1951

Answer 4

AKA “Prescription Drug Amendment” to FDCA
Established two classes of drugs (OTC and prescription)
-Prescription drugs do not require “adequate directions for use” as long as the labeling contained the legend “Caution: Federal law prohibits dispensing without prescription.” The dispensing pharmacist of an RX drug meets this requirement by including prescriber directions on the label.
-Also authorized oral prescriptions and refills on prescription drugs.

Question 5

Food Additives Amendment of 1958

Answer 5

• Requires components added to foods (food additives) must receive pre-market approval for safety.
• Delaney Clause, AKA “Anti-cancer Clause,” also prohibits approval of food additives that might cause cancer.

Question 6

Color Additives Amendment of 1960

Answer 6

• Requires manufacturer to establish safety of color additives in food, drug, and cosmetics.
• Anticancer clause also prevents cancer-causing color additives being approved

Question 7

Kefauver-Harris Amerndment of 1962

Answer 7

-AKA “Drug Efficacy Amendment”
-Requires new drugs to be proven effective as well as safe.
-Retroactive to all drugs since 1938
-Gave FDA jurisdiction over prescription drug advertising from FTC and required that all advertising carry labeling of possible side effects.
-OTC advertising is still with FTC
-Requires Good Manufacturing Practices (GMPs), FDA registration of manufacturers, recordkeeping requirements, and regular inspections.
Requires animal testing before human testing, informed consent of research subjects before clinical trial, and reporting of adverse events.

Question 8

Medical Device Amendment 1976

Answer 8

• Protects against potentially dangerous or useless medical devices.
• Provides for classification of devices according to function, requires pre-market approval like that of new drugs.
• Established
  1. performance standards and conformance with GMP regs
  2. recordkeeping and reporting requirements

Question 9

Federal Anti-Tampering Act of 1982

Answer 9

Federal crime to tamper with OTC products and required tamper-resistant packaging.

• Tamper evident required on some OTC drugs/cosmetics, especially PO. Dermatological, dentifrice, insulin, and lozenge are exempted
• Violations include
  1. Tampering malicious - fines, prison-life
  2. False communication @ tainted, fines prison-5
  3. Threats - fines, prison-5
  4. Conspiracy of 2+ people to violate - fines, prison-10

Question 10

Orphan Drug Act 1983

Answer 10

Created tax and exclusive licensing incentives for manufacturers to develop and market drugs or biological products for treatment of rare diseases or conditions that affect fewer than 200,000 Americans.

Question 11

Drug Price Competition and Patent-Term Restoration Act of 1984

Answer 11

AKA Hatch Waxman Amendment

• Made generics more readily available by streamlining generic drug approval process.
• Provided incentives for manufacturers to develop new, innovative drugs by giving patent extensions.

Question 12

Prescription Drug Marketing Act of 1987

Answer 12

• More stringent control of RX drug/sample distribution to address drug diversion
• Limited drug distribution beyond conventional retail sale
• Banning drug diversion from legitimate distribution channels
• Specifying precise storage, handling, and recordkeeping requirements for RX drug samples
• Banning sale, trade, purchase of prescription drug samples and making it illegal for a pharmacy possess RX samples
• Prohibits (w/exception) hospitals and other healthcare entitities from reselling pharmaceuticals to other businesses
• Requires state license of RX drug wholesaler under fed guidelines
• Banning reimportation of RX drugs produced in the US

Question 13

Safe Medical Devices Act 1990

Answer 13

Amendment to Medical Device Amendment 1976

• Gave FDA authority over medical devices and recalls for medical devices
• Expedited premarket device approval process
• Added postmarketing approval requirements
• Requires health care facilities to report problems to FDA

Question 14

Nutrition Labeling and Education Act 1990

Answer 14

• Mandates nutrition labeling on food
• Allows health claims on foods if conformed to FDA regs
• Standardized labeling terms “light” “low fat” etc

Question 15

Generic Drug Enforcement Act 1992

Answer 15

• Response to scandal of FDA staff bribed to facilitate generic drug approval process
• Felonizes false statements, bribes, failure to disclose material-related facts, and other related offenses

Question 16

Prescription Drug User Fee Act 1992

Answer 16

• Requires manufacturers to pay fees for applications and supplements when the FDA must review clinical studies
• Fees intended to hire more reviewers to speed up the new drug application (NDA) process

Question 17

Dietary Supplement Health and Education Act 1994

Answer 17

• Regulatory structure for dietary supplements more strict than food less strict than drugs
• Manufacturers must follow GMPs, but no premarket FDA approval is required
• Defines dietary supplement
• Permits structure and function claims w/o FDA approval
• Forbids claims that it can “diagnose, cure, treat, or prevent any disease” w/o FDA approval
• False or misleading claims are policed by FDA

Question 18

FDA Modernization Act 1997

Answer 18

• Streamlined regulatory procedures to ensure the expedited availability of safe/effective drugs/devices
• Increased public accountability of FDA
• Required compliance plan developed by industry, science, healthcare, consumer reps
• Created fast-track for drugs for serious/life-threatening dz
• Replaced Legend “Caution: Federal law prohibits dispensing without prescription” with “RX only”
• Clarified conditions where pharmacists can do extemporaneous compounding
• Exempted pharmacists from strict GMP regs and reqs for NDAs
• Created data bank for clinical trial info
• Authorized scientific panels to review clinical trials
• Expanded manufacturers rights to disseminate unlabeled use information and required specification that such use is not FDA approved
• Encouraged manufacturers to investigate new used of approved drugs and submit Supplemental NDA (SNDA)
• Eliminated manufacturer requirement for label “Warning-substance may be habit forming”
• Expanded FDA authority over OTC drugs with ingredient labeling requirements on inactive ingredients and preempted states from making OTC/cosmetic label requirements
• Mandates priority review for breakthrough medical device technology
• Allows FDA to contract science experts for medical device application review

Question 19

Best Pharmaceuticals for Children Act 2002

Answer 19

• Mechanisms for studying on- and off- patent drugs on kids
• Extends 1997 FDA Modernization Act provision offering additional 6 months patent exclusivity for on-patent drugs tested on kids

Question 20

Medicare Prescription Drug Improvement and Modernization Act 2003

Answer 20

• Added prescription drug and preventative care benefits to Medicare.
• Provides extra help for low income
• RX benefits started in 2006. ACA will phase out donut hole by 2020.

Question 21

Dietary Supplement and Nonprescription Drug Consumer Protection Act 2006

Answer 21

Established two mandatory reporting systems for serious adverse events: one for OTC and one for dietary supplements

Question 22

FDA Amendments Act 2007

Answer 22

• More FDA authority and requirements for pre- and post-marketing safety, like authority to require post-market studies/clinical trials, safety labeling changes, Risk Evaluation and Mitigation Strategies (REMS)
• Required “side effects” statement notifying patients to report ADEs
• Allows FDA to pre-review direct-to-consumer advertising
• FDA can make recommendations d/t censorship unconsititionality but can require changes addressing serious risks associated with drug’s use

Question 23

Family Smoking Prevention and Tobacco Control Act 2009

Answer 23

AKA Tobacco Control Act
-Gives FDA authority to regulate manufacture, distribution, and marketing of tabacco products to protect the public health

Question 24

FDA Food Safety Modernization Act 2011

Answer 24

Changed the focus of US food supply safety from responding to contamination to preventing it

Question 25

Drug Quality and Security Act (DQSA) 2013

Answer 25

Voluntary registration process in response to meningitis outbreak in 2012

• Drug compounding facilities that compound outside the traditional pharmacy practice can register with FDA
• FDA registered facility as an outsourcing facility can be exempt from FDA requirements like FDCA’s adequate directions for use requirements, new drug provisions, drug tracing provisions
• Registered facilities pay fees, subject to inspections, comply with labeling requirements

Question 26

Drug Chain Security Act (title II of DQSA)

Answer 26

Requires tracing prescription drug products through pharmaceutical supply distribution chain to protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harm