QUESTION 6 [Chapter 26] Are there any adverse consequences to ensuring that any new drug entering the market is as safe as possible? No, any new drug entering the market should be as safe as possible so that people taking the drug do not suffer any ill effects. No, it is for this reason that importation of foreign drugs into the United States is prohibited, because the public cannot be assured that they are safe. Yes, the longer it takes for the government to make sure the drug is safe, the longer the benefits of that drug are denied to patients who could benefit from it. O a and b QUESTION 7 [Chapter 26] What is the difference between the three stages of clinical trials? The number of people increases in each subsequent stage. A more powerful version of the drug is introduced in each subsequent stage. The first stage involves animal testing; the second stage uses human trials; and the third stage allows the drugs to be used by the public while the use is monitored for side effects. In the first stage, the drug manufacturer must present laboratory data to the Food and Drug Administration to prove the drug's safety; in the second stage, the drug is tested on animals for safety; and in the third stage, the drug is tested on a small group of humans. QUESTION 8 [Chapter 26] The Food and Drug Administration (FDA) approval process for a new drug can be quite lengthy. What was the purpose of Congress enabling the FDA to grant "fast-track" approvals to certain experimental drugs? Expedited approvals were granted for drugs whose scientific results were obvious. Expedited drug approvals were granted for patients who were terminally ill or suffering from life-threatening diseases. Expedited approvals were granted for drugs whose cost to develop and price to the patient would otherwise be prohibitive. Expedited approvals were granted only for those drugs whose manufacturers were willing to pay large expedited-drug fees. QUESTION 9 [Chapter 26] Are there any adverse consequences to longer Food and Drug Administration (FDA) approval times? Yes, longer FDA approval times reduce the effective patent life of a new drug and hence the drug manufacturer's profits and incentive to invest. No, longer FDA approval times result in greater safety of those drugs. Yes, longer FDA approval times delay the availability of beneficial new drugs to those patients who need them. O a and QUESTION 10 [Chapter 26] Are there any unintended consequences to requiring low price markups on innovative drugs that would otherwise be a financial burden on low-income patients? No, because the actual cost of producing the pills is very low No, because the drug has already been developed and the drug manufacturer will not find it profitable to stop producing the drug Yes, because the drug manufacturer will not be able to make the profits that provide an incentive to invest in research and development O a and b QUESTION 11 [Chapter 27] Do patients in the United States pay higher drug prices than patients in other countries? Yes, studies have shown that retail prescription drug prices in the United States are higher than in other countries. O No, comparative studies on drug prices in the United States and other countries do not include lower prices of generic drugs, which are used by many US patients. No, comparative studies on drug prices do not account for the large discounts received by large purchasers (such as insurers and drug plans, whose enrollees pay a small copayment) compared to the small segment of patients who buy drugs in cash at retail pharmacies. bandc