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Case Analysis
The Betaseron Decision
This case is about the dilemma Betaseron had over their MS treating medicine that was under extremely high demand but they were not able to fulfill all demand for the first 2 years. Betaseron is proven to greatly improve the quality of life for people with MS and is therefore under high demand. But due to the low production rates and the fact that Betaseron was unprepared to manufactured and distribute the medicine, it was estimated that they would have enough of it for less than 1/5 of the potential client base. This created the dilemma of who would receive the medicine and who would have to wait, among many other problems.
Even though there are many issues with the distribution and manufacturing of Betaseron, this is not the major problem. There is one major problem that lead to all this chaos and rush and that is the fact of how the FDA decided to expedite the approval process for Betaseron. This took one year instead of the standard three. Betaseron was not expecting this, the therefore had to dramatically upscale production and start to distribute the medicine in a relatively short amount of time. This lead to many other problems, such as who would get the medicine and who would have to wait. If Betaseron would have had the additional 2 years they had anticipated to get the medicine into production and distribution.
Analysis :
Betaseron, Chiron Corporation, and Berlex Laboratories all did the best things they could under the possible circumstances. They were anticipating a 3 years FDA approval process, which would have allowed them the time necessary to put Betaseron in production and distribution. Betaseron was the first and only drug that was proven to have an effect on the frequency of exacerbations. Therefore, Chiron Corporation had an extreme amount of pressure from people with MS and organizations supporting the research of MS to get the medicine out on the market and helping people as soon as possible, even if it would mean having to choose only select patients. Betaseron was greatly improving the quality of life for about 12.000-20.000 people in its first year of production (by the end of 1993). And they estimated that in 1996 they would be able to provide it to all who requested the Betaseron. So even though they are not able to fulfill all demand in the first 2 years, they are helping people 2 years earlier then they would have been able to do if the FDA would have taken the customary 3 years to approve Betaseron. Overall, Betaseron did the best thing they could have done in the available circumstances.
- Arfitra Siti Khairuma ( 21212057)
- Justina Elvida Harahap (24212010)
- Nur Bella Asrindo (28212335)
Case Analysis
The Betaseron Decision
This case is about the dilemma Betaseron had over their MS treating medicine that was under extremely high demand but they were not able to fulfill all demand for the first 2 years. Betaseron is proven to greatly improve the quality of life for people with MS and is therefore under high demand. But due to the low production rates and the fact that Betaseron was unprepared to manufactured and distribute the medicine, it was estimated that they would have enough of it for less than 1/5 of the potential client base. This created the dilemma of who would receive the medicine and who would have to wait, among many other problems.
Even though there are many issues with the distribution and manufacturing of Betaseron, this is not the major problem. There is one major problem that lead to all this chaos and rush and that is the fact of how the FDA decided to expedite the approval process for Betaseron. This took one year instead of the standard three. Betaseron was not expecting this, the therefore had to dramatically upscale production and start to distribute the medicine in a relatively short amount of time. This lead to many other problems, such as who would get the medicine and who would have to wait. If Betaseron would have had the additional 2 years they had anticipated to get the medicine into production and distribution.
Analysis :
Betaseron, Chiron Corporation, and Berlex Laboratories all did the best things they could under the possible circumstances. They were anticipating a 3 years FDA approval process, which would have allowed them the time necessary to put Betaseron in production and distribution. Betaseron was the first and only drug that was proven to have an effect on the frequency of exacerbations. Therefore, Chiron Corporation had an extreme amount of pressure from people with MS and organizations supporting the research of MS to get the medicine out on the market and helping people as soon as possible, even if it would mean having to choose only select patients. Betaseron was greatly improving the quality of life for about 12.000-20.000 people in its first year of production (by the end of 1993). And they estimated that in 1996 they would be able to provide it to all who requested the Betaseron. So even though they are not able to fulfill all demand in the first 2 years, they are helping people 2 years earlier then they would have been able to do if the FDA would have taken the customary 3 years to approve Betaseron. Overall, Betaseron did the best thing they could have done in the available circumstances.
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