Lehne Pharmacology Ch. 3

Question 0

Food, Drug and Cosmetic Act

Answer 0

(1938) Required all new drugs to undergo testing for toxicity; the test results were to be reviewed by the FDA and only those deemed safe would receive approval for marketing.

Question 1

Federal Pure Food and Drug Act

Answer 1

(1906) Required drugs to be free of adulterants

Question 2

Harris-Kefauver Amendment

Answer 2

(1962) Amended Food, Drug and Cosmetic Act to require that drugs be proved effective before marketing, retroactive to all drugs introduced between 1932 and 1962, and created rigorous procedures for testing of new drugs.

Question 3

Controlled Substance Act

Answer 3

(1970) Set rules for the manufacture and distribution of drugs considered to have the potential for abuse, defining five categories of controlled substances.

Question 4

Schedule I drugs

Answer 4

Have no accepted medical use in the US and deemed to have high potential for abuse. Ex: heroin, mescaline, LSD

Question 5

Schedule II drugs

Answer 5

?

Question 6

Schedule III drugs

Answer 6

?

Question 7

Schedule IV drugs

Answer 7

?

Question 8

Schedule V drugs

Answer 8

?

Question 9

Accelerated approval

Answer 9

(1992) FDA regulations changed to permit accelerated approval of drugs for AIDS and cancer; drugs could be approved for marketing prior to completion of Phase III trials provided rigorous follow-up studies were performed (Phase IV trials).

Question 10

Pros and cons of accelerated approval

Answer 10

Pros: 1) Drugs needed even if their benefits may be marginal, 2) unknown risks with early approval are balanced by the need for more effective drugs.
Cons: 1) Manufacturers often fail to complete Phase IV trials, 2) if Phase IV trials fail to confirm a clinical benefit, there is no clear mechanism for removing the drug from the market.

Question 11

Prescription Drug User Fee Act

Answer 11

(1992) Drug sponsors pay the FDA fees that are used to fund additional reviewers of applications for new drugs; the FDA must meet a strict review timetable; enables new drugs to reach the market sooner.

Question 12

Food and Drug Administration Modernization Act

Answer 12

(1997) 1) Fast track system for AIDS and caner drugs also apply to drugs for other serious and life threatening diseases, 2) Manufacturers must inform patients 6 months in advance of discontinuing a drug, 3) A clinical database will be established for experimental drugs for clinicians to review, 4) Drug companies are allowed to provide clinicians with journals about off-label use of drugs.

Question 13

Best Pharmaceuticals for Children Act

Answer 13

(2002) Offers a 6 month patent extension to manufacturers who evaluate a drug already on the market for its safety, efficacy, and dosage in children.

Question 14

Pediatric Research Equity Act

Answer 14

(2003) Gives the FDA the power to require drug companies to conduct pediatric clinical trials on medications that might be used in children

Question 15

FDA Amendments Act

Answer 15

(2007) Expands the mission of the FDA to include rigorous oversight of drug safety after a drug has been approved

Question 16

New drug development

Answer 16

1) Requires 6 - 12 years for completion, 2) Only a few out of thousands of compounds tested enter clinical trials, 3) Only 1 of five tested in clinical trials earn approval, 4) Average cost of developing a new drug can exceed $800 million!

Question 17

Randomized Controlled Trials

Answer 17

1) The most reliable way to objectively assess drug therapies.