Question
Central to this litigation is that what a manufacturer may lawfully claim that a drug does under the statutory and regulatory scheme, and what a
Central to this litigation is that what a manufacturer may lawfully claim that a drug does under the statutory and regulatory scheme, and what a physician may prescribe a drug for, do not match. Once a drug has been approved by the FDA for marketing foranyuse, the actual prescription choices regarding those drugs are left to the discretion of the physician.See, e.g.,59 Fed.Reg. 59820, 59821 (1994) (noting that the agency has restated this policy on numerous occasions). A physician may prescribe an approved drug for any medical condition, irrespective of whether FDA has determined that the drug is safe and effective with respect to that illness. That physicians may presently prescribe off-label is not in dispute.SeeDefendants' Response to Plaintiff's Statement of Material Facts 9 (noting that off-label prescribing is appropriate in the context of the physician-patient relationship);see alsoDeposition of William K. Hubbard, Associate Commissioner for Policy Coordination at 59-61 (March 21, 1996) ("Hubbard Deposition"). The FDA contends that it accepts the practice of off-label use by physicians as part of its enforcement discretion,seeDefendants' Response to Plaintiff's Statement of Material Facts 2; Defendants' Reply to Plaintiff's Memorandum in Opposition at 6 ("Defendants' Reply Memorandum"), though it appears to be an open question as
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*56to whether the FDA could currently regulate this aspect of the practice of medicine if it wished to do so.
1. Calculate how much these goods would cost a year
later if inflation reached 1600 per cent.
2. Comment on the scale of inflation in Venezuela.
3.Describe two negative impacts that households in
Venezuela have experienced as a result of inflation.
4.Marine was laid off due to changes in the structure of the
economy.
5. How might Marine improve her mobility in the labour
market?
6.What are the possible causes of unemployment in
Greece? Give at least two reasons in your analysis.
7. Describe the effect on unemployment of the
government raising the retirement age in Greece.
8 Assess the impact of high unemployment in Greece on
(a) output and (b) the government.30
9. What is meant by visible trade?
10. What is meant by the balance of trade?
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