FDA Budget Cuts This Week

This week, the FDA faces between 5.1 to 5.3% of their budget being cut this week ($210 million of a $4.1 billion budget). I’ll be interested to see what areas of the FDA are impacted by these budget cuts, and what that means for medical device manufacturers. Proposed to be included in those cuts are the user fees medical device & pharmaceutical companies pay the FDA for timely reviews of new medical devices & drugs. Zimmer’s CEO and AdvaMed chairman David Dvorak announced during a conference “The fees voluntarily paid by industry in exchange for meeting certain performance goals are not tax payer dollars and should not be considered in the same light as appropriation funding”. March 1st marks the deadline for when or if these budget cuts will be passed.

Although many device manufacturers are going to fully support the FDA receiving these voluntary fees, I’ve been unable to come across any indications that these budget cuts are not going to pass. If they do pass, these budget cuts will have a big impact on the amount of time it takes the FDA to perform their product reviews in a timely manner. I believe it is in everybody’s best interest if these budget cuts don’t happen – because the time it takes to get a product to market could be severely impacted by these budget cuts, which means patients don’t have new & improved products readily available to treat them.
-SJG