midterm 2: drug use + access + role of pharmaceutical industry ദ്ദി ༎ຶ‿༎ຶ )

What are the most visible treatments in medical care?

Pharmaceuticals

What is one reason consumers are so familiar with pharmaceuticals?

DTCA (direct-to-consumer advertising), simplicity of drugs

What are the three meanings of the word Pharmakon? What language does it originate from?

Originates from Greek and is the greek word for drug; its three meanings are “remedy,” “poison,” and “magical charm.”

What is using a medication for a condition that is not FDA-approved known as?

Unapproved/”off-label” use

What is medicalization? What are some examples?

Defines a personal or social problem as a medical condition that necessitates treatment. Examples include treatment of articulation disorder, obesity, and ADHD.

Consumer beliefs regarding medications are often very (similar/different) from the beliefs held by health care professionals.

Different

What are some factors influencing prescriber behavior?

Education

Colleagues or other healthcare providers

Demands by consumers and society

Promotional activities by drug manufacturers

Who determines which drugs are allowed to be sold and prescribed in the US?

FDA

Who determines which drugs are categorized as prescription or non-prescription?

FDA

Which acts are used by the FDA to control the development and manufacturing of pharmaceuticals?

Food, Drug, and Cosmetic Act (1938)

Public Health Service Act (1944)

Which act guides how the FDA regulates small molecules and hormones?

Food, Drug, and Cosmetic Act (1938)

Which act regulates biological drugs (much larger and more complex than small-molecule drugs)?

Public Health Service Act (1944)

What organization monitors the safety of the nation’s blood supply?

FDA

Once a drug is approved for the market, the FDA has full power to determine how it is ultimately used.

False; it has few powers

What are the steps in the drug development process?

Discovery research

Preclinical testing

Clinical testing

NDA submittal for approval

When does a drug manufacturer have to submit an IND application to the FDA?

After pre-clinical (animal) testing and before clinical testing

What does IND stand for in the drug manufacturing process?

Investigational New Drug application

How many phases are there in clinical testing?

Four

Around how many compounds are evaluated for each one drug that is approved by the FDA for marketing?

5,000-10,000 (slide with table says 5,000 so go w that)

Around how many compounds enter clinical trials for each one drug that is approved by the FDA for marketing?

5

How long does the drug development process take?

Around 15 years

Around how long does the FDA review the NDA before approval?

1.5 years

Who are the subjects in phase I clinical trials? What are phase I’s goals, and how long does it last?

<100 healthy volunteers; determine safety and dosage; 1-1.5 years

Who are the subjects in phase II clinical trials? What are phase II’s goals, and how long does it last?

100-500 (less than 300 according to slides) patient volunteers (with target disease/symptom); safety and efficacy in treating disease/symptom as well as potential side effects; 2 years

Who are the subjects in phase III clinical trials? What are phase III’s goals, and how long does it last?

1000-5000 (less than 3000 according to slides) patient volunteers (with target disease/symptom); confirm safety, dosage, and effectiveness and monitor long-term adverse effects; 3-3.5 years

Which department of the FDA reviews the NDA?

Center for Drug Evaluation and Research (CDER)

What is phase IV of clinical trials? What does it monitor for?

Phase IV refers to post-marketing surveillance after a drug has entered the market; it continues to monitor the drug’s safety and efficacy and monitor for side effects that may have been missed in earlier trials

What is an sNDA?

Stands for supplemental NDA; submitted to the FDA if firms wish to alter a drug’s ingredients, dosage, manufacturing, or labeling

What is an abbreviated NDA, and what is it used for?

An abbreviated NDA is a shortened form of the NDA that does not require any pre-clinical or clinical data. It is used for generic drug manufactureres to demonstrate that their product is bioequivalent with the brand-name equivalent drug.

What is bioequivalence?

When a drug has the same rate and extent of absorption into the bloodstream as the brand drug

What is pharmaceutical equivalence?

Drugs with the same active ingredient(s), dosage form, and strength (colors, taste, and other features may vary)

What are the two aspects of therapeutic equivalence?

Pharmaceutical equivalence + bioequivalence = therapeutic equivalence

What ultimately determines the price of a drug?

Manufacturer’s cost + profit

Wholesaler’s cost + profit

Retailer’s cost + profit

Discounts

Supply and demand

(T/F) Generally, it is legal to purchase prescription drugs in another country for use in the U.S.

False; it is illegal (there are some exceptions)

(T/F) With FDA approval, drugs developed and produced outside the U.S. can be sold in the U.S. as prescription drugs.

True

Over __ percent of drugs sold in the developing world are counterfeit.

30%

What are some benefits and downsides of foreign clinical trials?

Benefits:

• Allows for diverse populations in trials

Downsides:

• FDA not equipped to inspect many foreign trial sites

• Can be dificult to tell why patient outcomes differ between sites

• Each site may have different standards so data interpretation is limited due to lack of standardization

What act regulates IPRs for small-molecule drugs? How long does data exclusivity and patent protection last?

Hatch-Waxman Act of 1984; 5 years data exclusivity (from FDA approval) and 20 years patent

What act regulates IPRs for biologics? How long does data exclusivity and patent protection last?

Patent Protection and Affordable Care Act (PPACA) of 2010; 12 years data exclusivity (from FDA approval) and 20 years patent

Which drug type requires new (but limited) clinical trials for generics/biosimilars: small-molecule drugs or biologic drugs?

Biologic drugs