QDIS Blog

FDA and PUDFA

by Ed Vawter @ 4:33 pm. Filed under FDA

The following article gives some interesting insight into the FDA, PUDFA and how the FDA finances their agency.

Amid Doubts, FDA Makes Case for More User Fees (FDA Webview)

I still find it interesting that they loudly proclaim that it doesn’t influence their decisions. This runs counter to the Institute of Medicine report.

Assessment of the U. S. Drug Safety System - Institute of Medicine

And here is the actual report:

The Future of Drug Safety: Promoting and Protecting the Health of the Public

Here is the pertinent section of the IOM report:

An agency whose crucial mission is to protect and advance the public’s health should have adequate resources to do its job. Also, the effect on CDER’s work of CDER’s overdependence on PDUFAfunding with restrictions on how FDA can use the money from user fees hurts FDA’s credibility and may affect the agency’s effectiveness.

To support improvements in drug safety and efficacy activities over a product’s lifecycle, the committee recommends that the Administration should request and Congress should approve substantially increased resources in both funds and personnel for FDA. The committee favors appropriations from general revenues, rather than user fees, to support the full spectrum of new drug safety responsibilities proposed in this report.

I firmly believe that Congress needs to address the funding situation and would like to see the FDA given a reasonable budget and not have them rely on creative funding sources. While it may not actually affect their decisions, I think that even the appearance of conflicts should be avoided given how important the FDA’s job is and how it effects everyones daily lives.

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