Question by rashrash27: Please help me answer the following question ASAP?
A well-known pharmaceutical company, Robins & Robins, is working through a public scandal. Three popular medications which they sell over-the-counter have been determined to be tainted with small particles of plastic explosive. It has not yet been determined where the plastic explosives came from, but over $ 8 million in inventory is impacted. The inventory is located throughout the Western United States, and it is possible that it has also made its way into parts of Canada. A recall occurs but it is mostly unsuccessful.
Last fall, the FDA had promulgated an administrative rule which stated that all pharmaceutical companies which sold over-the-counter medications must incorporate a special tracking bar code (i.e. UPC bars) on all packaging, to ensure that recalls could be done with very little trouble. This bar code would have cost about $ .35 (cents) per package, which would have cost the company nearly $ 3 million on this batch of inventory.
Robins & Robins lobbied hard against this rule, and managed to get it stopped in the public comments period. They utilized multiple arguments, including the cost (which would be passed on to consumers). They also raised “privacy” concerns, which they discussed simply to get public interest groups upset. (One of the drugs impacted is used for assisting with alcoholism treatment – specifically for withdrawal symptoms and many alcoholics were afraid their use of the drug could be tracked back to them.) Robins & Robins argued that people would be concerned about purchasing the medication with a tracking mechanism included with the packaging and managed to get enough public interest groups against the rule. The FDA decided not to impose the rule.
The FDA decides to require all pharmaceutical companies to immediately implement the tracking bars (UPC) as a result of the disaster with Robins & Robins. Robins & Robins decides not to challenge this and begins the process of adding them to all of their products. However, McFadden, Inc., a New York pharmaceutical realizes that this new requirement is going to bankrupt them immediately. McFadden did not participate in the original public comment period. However, this rule
is different from the rule which went through that public comment period, in that it specifically names 4 companies as being impacted, Robins & Robins, McFadden, Inc., Bayer, and Johnson & Johnson. On what bases can McFadden challenge this requirement imposed by the FDA? Provide at least two bases under the Administrative Procedures Act. Would the injuries from the Robins & Robins situation impact the chances that this challenge would be successful? Why or why not?
Question 2, please help me ASAP
It is discovered that Robins & Robins knew about the tainted medication two months earlier than they announced the recall. They hid it, and in fact, sent out contract buyers to try to buy up all of the medication off the shelves. Their “fake” recall failed. Using the Laura Nash method of analyzing ethical dilemmas, analyze the ethical dilemma faced by the CEO of Robins & Robins for the fact that they saved 35 cents/package and are now in the middle of a major, life threatening recall. Analyze their “fake” recall as well. Show all of the steps of the model and give a recommendation to the CEO of what to do now that the deaths are escalating. What is the “right” thing for the CEO to do in this case? Did the model help you come to this conclusion or did you use some other method? Explain.
Best answer:
Answer by STEPHEN
McFadden can challenge the requirement by asserting the cost element and that its implementation would bankrupt them and make the same arguments that Robins & Robins made. Additionally, they could argue that the FDA is estopped by its prior decision to not impose the Rule; this, of course, could be countered by the argument that McFadden waived all arguments against imposition of the Rule by its failure to participate in the earlier public comment period. McFadden could also argue that the FDA is over-reacting to a calamity which could not be foreseen and is so rare an occurrence that it is highly unlikely to happen again, to which the FDA would contend that its statutory authority compels that it impose the Rule. The injuries of the Robins & Robins matter would be the only significant impact which would cause the imposition of the Rule. The two bases: (1) It would not be an abuse of discretion to impose the Rule. (2). The FDA may lawfully take administrative notice of the Robins & Robins calamity.
What do you think? Answer below!
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