Question

Which of the following statements is true? a. One reason why total health expenditures are rising is because of an aging population. b. The Food and Drug Administration (FDA) decides whether to approve a drug for use in the U.S. based in part on whether each drug is cost-effective in the treatment of some disease. C. In the U.S., drug companies receive a patent of 100 years for each drug they develop. This allows them a prolonged legal monopoly on the sale of that drug. d. Phase II drug trials are conducted on animals, while Phase III drug trials are conducted on healthy volunteers. Both are required for FDA approval.

Answer 1

The accurate statement is 'a. One reason why total health expenditures are rising is because of an aging population.' The FDA does not consider cost-effectiveness as a primary factor for approval, and the patent life for drugs is generally 20 years.

Step-by-step explanation:

The correct statement among the options provided is that one reason why total health expenditures are rising is because of an aging population. The Food and Drug Administration (FDA) indeed decides whether to approve a drug for use in the U.S., however, it does not typically consider cost-effectiveness as a primary factor for approval. Instead, the focus lies on the safety and efficacy of the drug. The patent life for new drugs in the U.S. is not 100 years, but typically 20 years from the date the patent application is filed. Lastly, Phase II and Phase III drug trials are generally conducted on human subjects, not animals. Phase II trials are administered to a larger group of people to determine efficacy and further evaluate safety, while Phase III involves larger populations to confirm effectiveness, monitor side effects, and compare it to commonly used treatments.

The 'winners' in the regime of strict medical regulations are the general public and patients, who are safeguarded from potentially harmful or ineffective medications. On the other hand, the 'losers' can be those who may be deprived of access to potentially beneficial drugs due to the long, rigorous, and expensive process of FDA approval, which can delay market access. This includes patients suffering from diseases for which there are no effective current treatments and who might benefit from more experimental therapies that are still in the approval process.