I feel that this question has not been answered at all. I was advised by the medical department at MSD that levadopa was an important consituent of Sinemet and that the shortage was as a result of supply problems. Why is it that MSD cannot make Sinemet at the moment due to "short supply" when there is at least one generic version of Sinemet available on the market in the UK. I would like a direct and open response please - not spin.
Topic: what does the shortage not affect generic co-careldopa.
Please you could clarify the reason that the ingredient supply was changed. I think this fact is pivotal. For example, was the change a sudden unavoidable requirement that did not allow enough time to manage the situation before a shortage developed?
Panda.
In response to: Communication from the Medical Director
Panda.
In response to: Communication from the Medical Director
Unless I am missing something, MSD have still not answered the specific points about whether they anticipated the need to go through the regulatory approval process for the change in supply of an ingredient of Sinemet, and if so why they did not wait until approval was forthcoming before changing the supply. These are important questions that get to the heart of whether MSD handled things as well as they could have, and whether the regulatory approval process is working against patients' interests in some instances.
So I ask again:
(a)Did MSD anticipate the need to go through the regulatory approval process for the change in the supply of the ingredient?
(b) If so, why did they not wait until approval was forthcoming before changing the supply?
In response to: What is the reason for the shortage
So I ask again:
(a)Did MSD anticipate the need to go through the regulatory approval process for the change in the supply of the ingredient?
(b) If so, why did they not wait until approval was forthcoming before changing the supply?
In response to: What is the reason for the shortage
Many thanks for responses. Unfotunately my computer has rebelledand i can't read many answers as yet
There is nothing in your answers that isn't there in previous statements.
Why cant you answer honestly about why this shortage happened, and when you are going to restore medication supplies to normal levels?
It took a very long time to come up with nothing new. You say that you had to change the supply of the raw material, you should explain what happened, what led to it,and why there was no backup plan to protect patients. This is not a new drug, it's been around for a long time, and a 2 year shortage must have been caused by some decision taken by Merck MSD. It is hard to understand why you are not being more open.
Why cant you answer honestly about why this shortage happened, and when you are going to restore medication supplies to normal levels?
It took a very long time to come up with nothing new. You say that you had to change the supply of the raw material, you should explain what happened, what led to it,and why there was no backup plan to protect patients. This is not a new drug, it's been around for a long time, and a 2 year shortage must have been caused by some decision taken by Merck MSD. It is hard to understand why you are not being more open.