USV Pharmaceutical Case

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In this case, an interesting ethical discussion concerning the reasonable application of safety and efficacy to terminally-ill patients is brought forward. I agree with the holding that the right to access untested or unproven therapies was inexistent in the case. Recognizing that there is an apparent protected right to decline life-saving therapy or treatment, the Court moved to distinguish it from a positive privilege to access a specific medication or treatment. It is discussed that a drug is as hazardous for the terminally-ill individuals as for any other person if its prospects of physical injury and death are not prevailed over by the prospects for gain and the FDA had not established that Laetrile was effective and safe. Nonetheless, I do not think under the present-day laws, the court would not have decided in the same way; legislations have been enacted; in line with the spirit of the Constitution of protecting ones liberties, to allow for expanded access for terminally-ill individuals to experimental drugs.

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Weinberger & Dunning V Hynson Westcott and USV Pharmaceutical V Weinberger

Although they were decided on the same date, the decisions of the two cases are consistent with each other. Under the 1962 amendments to the Federal Food, Drug and Cosmetic Act of 1938, they raise a sequence of questions over the Act. The Act that established a premarketing drug clearance system, proscribed the introduction of a new drug into the market unless there was an effective new drug application (NDA) relating to the drug, file with the FDA. Under the Act, the new drug was not overall acknowledged by qualified professionals as safe for use hence the government could file a suit to enjoin violations. In both cases, it was decided that the amendments introduced in 1962 as well as the articulated regulations issued, which express properly established guidelines of scientific investigation in reducing the standard of substantial evidence to detailed principle for the protection of the people, validates the administrative summary judgment process or procedure of the FDA . Lastly, the two cases held that FDA has a primary jurisdiction in the determination of a status of a drug, and it cannot be stated to be effective until substantive evidence has been ascertained through proper procedures.

USV Pharmaceutical case

The Supreme Court, in affirming the decision of the Circuit Court, that certain products cannot be grandfathered by the earlier-sold products, that is they can only be sold after undergoing further testing, does not create its own law on the issue. The Supreme Court declined to allow to express approval; stating that the amendments to the Federal Food, Drug and Cosmetic Act of 1938 are only comprehensively meaningful if they do not provide the manufactures of drugs with a loophole to utilize in marketing substandard drugs on the basis of grandfathered approvals. Under the new statutory regulations, there is need to demonstrate that the drugs are effective and are safe for the intended audience. The efficacy alongside the safety of every drug being introduced though had been marketed earlier, should apply to every new proprietary drug. However, the Supreme Court moves to ensure effective investigative procedures, by asserting that proprietary drugs presently on the market; under the new bill, were not subject to provisions demanding the support of the claims of efficacy upon a FOA notice.

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