QDIS Blog

I found this article interesting regarding drug companies paying the FDA to review TV ads for drugs to make sure they do not contain any violations. This is voluntary; drug companies do not have to do this but many do. This is somewhat akin to the PUDFA (Prescription Drug Users Fee Act) where the drug manufacturers pay to get their applications reviewed and the money goes to hiring more staff to ensure timely approvals.

Drugmakers to pay FDA to OK ads: WSJ | Entertainment | Industry | Reuters.com:

What is interesting about this is one of the recommendation from the Institute of Medicine concerning reforms within the FDA was the elimination of just such funding. They believed that it is better for congress to fun the agency at an appropriate level for the amount of work they are required to do.

I should point out that this is not yet finalized since FDA’s parent depart the the Department of Health and Human Services has not yet approved this and it would also require Congressional approval.. It is estimated that the FDA would get ~$300 million in 2007 and $400 million in 2008.

I tend to agree with the IOM report that Congress should really be the ones responsible for funding. Congress gets to avoid dealing with the agencies funding by allowing this to happen and it could be abused. There is currently no evidence of this but the generic scandal in the past should be kept in mind. I personally think there needs to be more oversight and more budget for the FDA but also think that more attention needs to be paid to how those funds are acquired.

Technorati Tags: drug ads, FDA

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