The FDA Approved a $ 300,000 a year drug The FDA Approved a $ 300,000 a year drug https://www.wsj.com/articles/how-the-fda-approved-a-300-000-a-year-drug-its-own-experts-didnt-believe-worked-1495116544 Please Read the WSJ article “How the FDA Approved a $300,000-a-Year Drug Its Own Experts Didn’t Believe Worked ” referenced above. Outline the FDA drug approval process for the various types of drugs. How was this different in the case of the article? How do prescription drug patents affect the market for prescription drugs? Is Pharmaceutical R&D a process that adds value to the resources it uses? What is moral hazard in economics? it be applicable in this case? Does the Pharmaceutical Patent Process create economic value? How ? Use FDA approval process timetable below to assist you. Please analyse, elaborate and substantiate your answers Phase Aim Notes Phase 0 Pharmacodynamics and pharmacokinetics in humans Phase 0 trials are the first-in-human trials. Single subtherapeutic doses of the study drug or treatment are given to a small number of subjects (10 to 15) to gather preliminary data on the agent’s pharmacodynamics (what the drug does to the body) and pharmacokinetics (what the body does to the drugs). For a test drug, the trial documents the absorption, distribution, metabolization, and removal (excretion) of the drug, and the drug’s interactions within the body, to confirm that these appear to be as expected. Phase 1 Screening for safety. Testing within a small group of people (20–80) to evaluate safety, determine safe dosage ranges, and begin to identify side effects. A drug’s side effects could be subtle or long term, or may only happen with a few people, so phase 1 trials are not expected to identify all side effects. Phase 2 Establishing the efficacy of the drug, usually against a placebo. Testing with a larger group of people (100–300) to determine efficacy and to further evaluate its safety. The gradual increase in test group size allows for the evocation of less-common side effects. Phase 3 Final confirmation of safety and efficacy. Testing with large groups of people (1,000–3,000) to confirm its efficacy, evaluate its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow it to be used safely. Phase 4 Safety studies during sales. Postmarketing studies delineate additional information, including the treatment’s risks, benefits, and optimal use. As such, they are ongoing during the drug’s lifetime of active medical use. (Particularly relevant after approval under FDA Accelerated Approval Program)
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