Who or what is Gdufa?
Is Gdufa the answer to the problem of generic drug manufacturing and the lack of transparency and accountability in the entire process? Can we return to a time of naivety when we never thought or worried about this subject? Should we return to that time?
Gdufa stands for Generic Drug User Fee Amendments of 2012. It actually goes by Gdufa, and if you type that into Google, the information about the act is what shows up. I will summarize its purpose and what it hopefully means for everyone. First, some surprising numbers.
Since 1984 over 8,000 generic drugs have been approved by the FDA. In 2011, 78% of all drug prescriptions were for generic drugs, and the estimated cost savings was $931 billion. Almost a trillion dollars in one year alone. I, and others like me, would have thought that somehow this savings should be protected as well as the public's safety. Isn't that what the FDA does?
It seems that isn't the case. Why? The same reason things usually don't get done: money. In the era of deficits and "small government," the protection of the American public took a backseat to expediency. The system got a trillion dollars in savings and you got...who knows. Somehow Afghanistan can be billed to us the taxpayers but drug protection...not so much.
Well our problem is solved. The money to do what is needed is coming from the foxes guarding the hen house. The generic drug manufactures are going to provide $299 million a year in inflation adjusted dollars. This represents one half of 1% of generic drug sales. What did the drug manufacturers get? Currently it takes 31 months on average to approve a new generic drug. Seriously, I'm not making this up. 2,500 applications were awaiting approval at the time of the bill passage. This time will be significantly shortened, and the FDA will have to be accountable to Congress. The FDA promises to review 90% of the new applications within 10 months of the submission date by the 5th year of the agreement.
What did we, the people, get? Currently the FDA inspects foreign drug manufacturers once every seven to 13 years. I'll bet that scares them. Now they will be inspected every two years with the riskiest sites being inspected more frequently. Further, all facilities that manufacture drugs and their components will now be identified.
Certainly this is a good start. Execution will be the problem as always. It is hard for me, and I'm sure for you, to understand how this was not always the way it was. Is glass in generic Lipitor the only problem?
One final note: the bill strives to create an improvement in, as they call it, "regulatory science." Basically this refers to testing and maintaining the generic drugs to ensure they meet the potency and same activity that the formal product has. When there were just a few drugs and manufacturers, this was not such a problem. If 15 companies make the same generic Lipitor, are they all the same? Can we choose or does the pharmacy just give us the pills and tell us, as my mother used to say, "take your medicine"?
I can guarantee you that this event, the finding of glass in generic Lipitor, is just the first in what will be a long line of problems. We must as a country solve this problem and devise ways to protect patients from drugs that do not work or are harmful.