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What was the FDA's response to the urgent need of patients for another effective drug against AIDS?

-Allowed the use in AIDS patients of candidate drugs without requiring safety and efficacy tests in humans
-Allow the uncontrolled introduction of newly approved drugs across state borders
-Allowed the marketing of less expensive generic copies of branded drugs to AIDS patients
-Allowed patients pre-approval access to drugs still in clinical trials that are not yet FDA-approved for marketing
-"In cases of urgent medical need, allow the use of non-sterile drug products"

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User Aundrea
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1 Answer

2 votes

Final answer:

The FDA responded to the urgent need for effective AIDS drugs by allowing pre-approval access to new therapies still undergoing clinical trials, influenced by advocacy pressure from groups like ACT UP. These actions sought to balance drug safety and efficacy with immediate patient needs.

Step-by-step explanation:

The FDA's response to the urgent need of patients for another effective drug against AIDS involved providing expanded access to drugs still in clinical trials. This policy allowed patients to gain pre-approval access to potential treatments before they completed the standard FDA approval process. The prominent issue at the time was the slow federal response to the AIDS crisis, which was confronted by activists such as the AIDS Coalition to Unleash Power (ACT UP), who pushed for expedited testing and approval of medications. Bypassing some of the lengthy testing requirements, which sometimes took years of evaluation, allowed AIDS patients to access potentially life-saving treatments more quickly while they were still under investigation.

The pressure from advocacy groups like ACT UP led to the FDA taking steps to fast-track drug testing and approval, particularly for drugs that showed promise in treating HIV/AIDS. This was a significant deviation from the FDA's typical regulatory processes, which are designed to ensure the safety and efficacy of drugs, but which could delay access to drugs for patients with life-threatening conditions like AIDS.

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User Sadegh Ghanbari
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8.2k points
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