FDA - New Drug Protocol

A board to discuss the newly-released drug Tysabri, (formerly known as Antegren) as a treatment for Multiple Sclerosis

FDA - New Drug Protocol

Postby DenverCO » Wed Jun 08, 2005 10:26 am

There's a good story on NPR's Morning Edition today about the FDA's procedure for follow up on newly approved drugs. There is a scientific review commitee (convening today) created to evaluate how this method can be improved.

Currently the FDA has 2 methods of follow up in place for fast track drugs:
1) Spontaneous Adverse Reaction Reporting System - almost tota lly ineffective because busy physicians, pharmacists, etc. do not take the initiative to report what they observe.
2) Mandatory follow up (continuation of the trial) by the pharmaceutical company that manufactures the drug.

In light of this story, it should be noted that Biogen's fast track of Tysabri was not an isolated incident by a, some would argue, particularly greedy unethical drug company. (For the record, I am NOT in the camp of consumers who feel this way.) Fast track approval occurs, and we are going to see more of it as drug companies shift their focus to therapies for tough diseases like MS.

Taken into consideration, this info should alleviate some of the harsh criticism of the drug companies. IMO, they provide a service that we would be SOL without. Furthermore, that industry has exorbitant R&D costs which must be absorbed by the consumer. There is no free lunch. Their endeavors are not philanthropic. Somebody has to pay. If you believe the federal government should provide a subsidy, that would be passed along to the masses in the form of higher taxes...and that's not fair since the majority of people don't have off-the-chart expensive medical conditions.
Last edited by DenverCO on Wed Dec 10, 2014 10:26 am, edited 1 time in total.
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Re: FDA - New Drug Protocol

Postby HarryZ » Wed Jun 08, 2005 6:05 pm


I personally don't have a problem with a pharmaceutical company fast-tracking a drug...as long as they have done their homework in doing so. And I guess this is where the debate with Biogen/Elan and Tysabri comes into play.

Without rehashing a lot of what has been said in the past by me and others, Tysabri is a drug that can have a large effect on a patient's immune system. MS patients are well known for having taken immune suppressant drugs. Combine the two situations and you can have a potentially serious event and this was a warning that was given by some MS docs long before Tysabri was approved by the FDA.

Yet, the fast tracking continued and we all know the results.

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