HAPP411 FDA

How long does the clinical trial take?

18months

What is PDUFA?

1992 Prescription Drug User Fee Act—fees(Review new drugs)

What are the main components of FDAMA?

1997- Food and Drug Administration Modernization Act • Increased "fast-track" options • Increased the opportunities for pediatric testing • Allowed for an encouragement of the use of drugs for off-market conditions • Also allowed drug manufacturers to promote products for off-market use • Opened up the advertising market even further to manufactures and decreased the FDA's already limited ability to regulate advertising

Expedited review must complete in __months (10 months standard review) and decisions on expedition in ___ days

6 & 60

What controversies may arise (PDUFA)?

Concerns regarding lower quality reviews verses expediency in getting drugs on the market. Controversy-About 1⁄4 of the FDA's budget comes from PDUFA fees, leading to concerns about conflicts of interest

What is DTC and why is it significant?

Direct-to-Consumer. advertising expanded in the 1990s. Ads must: • Provide at least one approved use • Tell the side effects and risks • Provide the generic name of the drug • Have more thorough information available in print (for non-print ads) DTC ads are one explanation for the increased spending on drugs in recent years

What different agencies work together to regulate the advertising of drugs?

FDA, FTC,ATF

What did Wheeler-Lea Act authorize?

FTC to regulate advertising of products subject to FDA oversight (except prescription drugs)

What was the first way that drugs were regulated I the US and why?

Food Drug and Cosmetic Act:1937, Sulfanilimide (antibiotic) made in liquid form with diethylene glycol (antifreeze). Led to the deaths of 107 children. • No pre-market testing was done, or required, at the time • Food, Drug, and Cosmetic Act (1938) established procedures to review drug safety, among others

What were the limitations of PFD act , and how did future regulations address them?

Initially only regulating what manufacturers listed as the ingredients, didn't regulate the safety of the medication.

How are nutritional supplements and vitamins regulated?

Not considered "Drugs" and not subject to clinical trials process of prescription drugs

What does OTC stand for and why is it significant?

Over-the-counter.1951- Durham Humphrey Amendment: Defined which drugs could be sold over the counter (OTC) and which must be taken with oversight of a doctor • Habit forming • Toxicity • Originally approved under guidance of physician, then must stay under prescription

What are the stages of the clinical trial process?

Patents are acquired for new biologic ingredients (active and non-active) Animal testing Investigational New Drug (IND) application to FDA (early 1960s) Phase I—small group of healthy volunteers (adverse effects, dosage tolerances, route of administration) 1/3 Phase II-Small group Phase III-Large group,clinical use 25% Phase IV Surveillance-longitudinally

FDA's dominant regulation

Pure Food and Drug Act of 1906

What is drug re-importation and what effect does it have on price?

refers to the practice of importing back to the United States prescription drugs that were originally manufactured in the U.S. and exported for sale in another country. Lower prices, could be tampered with

How are nutritional supplements and vitamins regulated by FTC?

regulates advertising and nutritional claims

How does ATF regulate the advertising of drugs?

regulates advertising of alcohol and tobacco, as well as identifying and prosecuting the illegal sale, distribution, or trafficking of alcohol and tobacco products. We currently lack any regulation of e- cigarettes or vaping products.

How are nutritional supplements and vitamins regulated by FDA?

regulates the accuracy of the label, ingredients

How does FTC regulate the advertising of drugs?

regulates the advertising of food and drugs. Must follow certain structure set by the FDA and USDA, Primarily nutrient and health claims

How does FDA regulate the advertising of drugs?

regulates the labeling on food and drugs. Must include all ingredients and not make misleading or false claims

Drug developers/manufacturers pay a fee to have the FDA expedited review of new drugs?

true

What was the Pure Food and Drug Act, and what was the event that led to its passage?

was the first of a series of significant consumer protection laws enacted by the Federal Government in the 20th century and led to the creation of the Food and Drug Administration. Its main purpose was to ban foreign and interstate traffic in adulterated or mislabeled food and drug products, and it directed the U.S. Bureau of Chemistry to inspect products and refer offenders to prosecutors. Meat packing industry led Congress to passing laws. Jungle,lack of sanitation. Workers rights.

What are primary goals and responsibilities of the FDA?

• Protect the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation • Advance the public health by helping to speed innovations that make medicines more effective, safer, and more affordable and help the public get the accurate, science-based information they need to use medicines and foods to maintain and improve their health Regulate the manufacturing, marketing and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. • Ensures the security of the food supply and by fosters development of medical products to respond to deliberate and naturally emerging public health threats.