Question

In a short but well-structured essay (3-5 paragraphs), explain

1-FDA Drug Evaluations in terms of Type I vs. Type II Errors.

2- Why can drug manufacturers charge more for drugs in the United States than in other countries? What is (are) the solution(s) for high drug prices in America?

Hint: in your essay you may talk about the cost of approving an safe, unsafe drugs

Answer 1

ans 1=Drug testing in the U.S is presently biased toward the minimization of ‘Type I’ error, i.e, toward minimizing the chance of ratifying drugs which are unsafe / ineffectual. This regulatory focus of the FDA ignores the possibility for committing the alternative ‘Type II’ error, i.e, the error of not ratifying drugs which are, in fact, safe & effectual. Such Type II errors can outcome in the loss of considerable advantages to society when the sale of drugs which are safe & effectual is prohibited. The current drug approval arrangement lays enormous stress on ‘Type I’ errors & by and large ignores ‘Type II’ errors, thereby augmenting the cost of drug testing & deferring the availability of effectual & safe drugs. A more balanced set of FDA drug approval criteria, accounting for the consequences of Type I as well as Type II errors, could outcome in better results, as compared to the current system

ans 2=The U.S is exceptional in that it doesn’t regulate / negotiate the price levels of new prescription medicines when they arrive in the market. Other nations task a governmental agency to meet with pharmaceutical firms and haggle over an apt price level. These agencies will normally make decisions about whether these new medicines represent any enhancement over the old medicines — whether they are even worth bringing in the marketplace first & foremost. The U.S permits drug makers to fix their own prices for a particular commodity — & permits each drug that is proven to be safe to come into the market.

If the U.S sets up an agency to negotiate medication prices on behalf of the nation’s 319 million inhabitants, it would perhaps be able to demand discounts like the European nations