Readings for 10/22/19
Three Interesting Things:
1.) I think it is interesting that samples were even allowed in the beginning. Once a drug is taken to market there has been so much research done to prove that this drug is safe and effective. Why would the manufacturing company want to risk the work they did in a clinical trial by distributing samples with improper instructions on how to store or package the drug.
2.) I find it interesting the drugs cannot be imported into the country due the fact that the FDA has not regulated them on safety and efficacy. This makes me understand more how individuals with certain conditions seek treatment in other countries because those therapies cannot be done in the US based on regulatory grounds. Unless they are imported in small doses and for serious conditions, they cannot be used in the US. I guess this could stop patients fro importing drugs not yet regulated and then reselling them to others for profit.
3.) I think it is interesting how the E-Sign has caused such controversy. Specifically, how the act of using paper document for prescriptions might be void because the electronic signature would override it. If someone trued to use the paper signature over the E-sign or the E-sign over the paper prescription, then they would be null and void; it has to be one or the other.
Three Questions:
1.) If state regulation must not impede on federal regulation of drugs then why is marijuana handled desperately? How come in the case of the Californian terminally ill resident, the DEA said it was legal in California but not federally so they destroyed the plants rather than prosecuting?
2.) Would wholesaling drugs be a form of a grey market channel or a black market?
3.) Why would Plan B be instituted as a prescription only drug if it showed no abuse and minimal physical/mental harms?
1.) I think it is interesting that samples were even allowed in the beginning. Once a drug is taken to market there has been so much research done to prove that this drug is safe and effective. Why would the manufacturing company want to risk the work they did in a clinical trial by distributing samples with improper instructions on how to store or package the drug.
2.) I find it interesting the drugs cannot be imported into the country due the fact that the FDA has not regulated them on safety and efficacy. This makes me understand more how individuals with certain conditions seek treatment in other countries because those therapies cannot be done in the US based on regulatory grounds. Unless they are imported in small doses and for serious conditions, they cannot be used in the US. I guess this could stop patients fro importing drugs not yet regulated and then reselling them to others for profit.
3.) I think it is interesting how the E-Sign has caused such controversy. Specifically, how the act of using paper document for prescriptions might be void because the electronic signature would override it. If someone trued to use the paper signature over the E-sign or the E-sign over the paper prescription, then they would be null and void; it has to be one or the other.
Three Questions:
1.) If state regulation must not impede on federal regulation of drugs then why is marijuana handled desperately? How come in the case of the Californian terminally ill resident, the DEA said it was legal in California but not federally so they destroyed the plants rather than prosecuting?
2.) Would wholesaling drugs be a form of a grey market channel or a black market?
3.) Why would Plan B be instituted as a prescription only drug if it showed no abuse and minimal physical/mental harms?
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