Intro. to Public Health Riegelman & Kirkwood Ch. 13: Food & Drugs

The Federal Food and Drugs Act

- 1906 -Creates what is known today as the FDA -Products are required to have accurate labeling indicating their ingredients

Federal Food, Drug, and Cosmetic Act

- 1938 -Required safety testing prior to making a new drug available to the market

Kefauver-Harris Drug Amendments

- 1960s -Focused on efficacy, not safety, and mandated efficacy testing before a drug could be approved and marketed -Due to thalidomide use and resulting birth defects

Describe SNAP

- It is one of the USDA's food security programs - formerly called "food stamps" - makes relatively expensive items, such as fresh fruits and vegetables, accessible to those with low incomes

Describe the Special Nutrition Program for Women, Infants, and Children (WIC)

- It is one of the USDA's food security programs •Federal grants to states for supplemental foods, healthcare referrals, and nutrition education •For low income pregnant women, postpartum women, and infants and children up to age 5 at nutritional risk

what are some products, besides drugs, that the FDA regulates?

- cosmetics - medical devices - biological products, such as blood supply - tobacco products, including nicotine and e-cigarettes

what does FDA approval of a drug imply?

1. FDA approval implies that the drug may be advertised and marketed for a particular indication, the one for which it was studied an approved 2. the drug may be prescribed y clinicians for any patient

What are the (7) steps in foodborne outbreak investigations?

1.Detecting a possible outbreak 2.Defining and finding cases 3.Generating hypotheses about likely sources 4.Testing the hypothesis 5.Finding the point of contamination and the source of the outbreak 6.Controlling the outbreak 7. Deciding that an outbreak is over

When did the U.S. Supreme Court allows advertising of prescription drugs?

1990s

When were new food and drug laws created to improve safety?

2000s

Describe the CAC

Initiated as a joint program of FAO and WHO that develops food standards, guidelines, and codes of practice; these now form the basis for the rules of global trade under the jurisdiction of the WTO

What does the Food Safety Modernization Act do and when was it passed?

It was passed in 2010, and it: -Gave the FDA and USDA increased authority -Provided the ability to track foods, including their origin, date of production, and other data that could be useful in locating the source of the food, if a disease outbreak occurred

Can dietary supplements be promoted as treatment for or prevention of a disease?

No

is the FDA responsible for determining safety of dietary supplements?

No; the manufacturer is responsible

Describe the CDC

Not a regulatory agency, but responsible for ongoing surveillance, as well as acute investigations in collaboration with state and local health departments

Describe the FDA

Overall responsibility for food safety regulation in the United States

what is phase 1 of drug trial?

Phase 1 is the initial administration of a drug to a human being. - Focuses on the pharmacology of the drug (absorption, metabolism, excretion) - Aims to establish dosage rage & route of administration - Examines safety issues and side effects - Short exposure to drugs - Small # of participants

What is Phase 3 in a drug trial?

Phase 3 trials are large, randomized control trials. Two independently performed, randomized controlled trials, unless not practical or ethical - Establish efficacy for one indication among a homogeneous group of patients compared to conventional treatment. Investigate short-term safety relative to conventional treatment

Describe the EPA

Regulation of pesticide usage and the establishment of water quality standards

what did the Food and Drug Administration Amendment Act of 2007 do?

The FDA Amendment Act provided new authority to the FDA to: 1. Require that more representative patients be included in randomized control trials 2. Require follow-up studies of drug to monitor their performance in clinical practice 3. Develop large database systems to link pharmacy records with electronic medical records to asses side effects on an on-going basis. 4. Place increased restrictions on who can prescribe a particular drug and what conditions need to be fulfilled before it can be prescribed 5. Approve and monitor drug advertising to clinicians and patients 6. Withdraw drugs from the market when serious issues of safety are raised.

Describe the FAO

The UN agency with overall responsibility for the food supply, with special emphasis on ensuring an adequate supply of food worldwide

How does the USDA aim to prevent food-related disease and disability?

The USDA administers food security programs which: -Require that all people at all times have access to sufficient, safe, nutritious food to maintain a healthy and active lifestyle -Cover approximately 15% of the U.S. population

What does the Foodborne Diseases Active Surveillance Network (FoodNet) do?

Works to prevent foodborne diseases. -Aims to identify and investigate foodborne disease from both outbreaks and routine exposure -Estimates the number of foodborne illnesses, monitors trends in incidence over time, attributes illnesses to specific foods and settings, and disseminates this information It is a collaboration between the CDC, FDA, and USDA.

what is a drawback to using animal models to test new drugs?

animal models may either fail to detect subsequent effects in humans or demonstrate high-dose effects that are difficult to interpret

According to the National Academy of Medicine, how many Americans die each year as a result of adverse effects of drugs?

nearly 100,000

what is off-label prescribing?

off-label prescribing: the prescribing clinician has the authority to use the treatment for indications or at dosages not specifically approved by the FDA

What is phase 2 of drug trial?

phase 2 establishes the efficacy of the drug for a particular use. - Phase 2 trials are small, sometimes uncontrolled - establish proof of concept (does the drug actually lead to the expected and improved outcomes?)

what is phase 4 of a clinical drug trial?

phase 4 involves post-marketing surveillance and monitoring of side effects of the drug.

what needs to happen before any human beings receive a new drug?

preclinical research and testing of the drug

how are adverse effects of a drug monitored in phase 4 after FDA approval?

spontaneous reporting system: those who prescribe the drug as well as patients are encouraged to report side effects to the FDA, but they are not required to.

Who is most vulnerable to foodborne diseases?

the very young, very old, and immuno-compromised

What ways can food affect health and disease?

too little food, too much food, deficiencies of vitamins and minerals, contaminants, individual susceptibilities, foodborne communicable diseases

what are some drawbacks to phase 3 drug trial? what are some limitations to establishing safety?

trials are too small, too short, and too simple. phase 3 is very expensive, potentially harmful, and time-consuming

true/false: The FDA requires animal safety studies before a drug can be studied in humans

true

how many species are new drugs tested on in animal testing? Is the same dose used on the animals as would be used in humans?

two different species; no, animals receive a higher dose than would be used in humans

Describe the WHO

•Not a regulatory agency, but establishes policy and makes recommendations regarding the safety of the world food supply through its FOS

Describe the USDA

•Regulatory responsibilities for meat, poultry, and eggs in the United States

What is the state/local government's role in food issues?

•State and local health departments conduct restaurant inspections, outbreak investigations - Consumer protection agencies provide education in safe food purchasing, preparation, and storage