FDA reveals $94m user fee increase

Share this article:
FDA drug and biologic user fees will jump almost 30% next year—from about $300 million to almost $400 million in 2008, according to details released about the PDUFA 4 negotiations.

The agreed-upon increase, which is yet to be submitted to Congress, directs $37.9 million to fund proposed enhancements to the PDUFA program.

The remaining amount is spread among a calculated “workload adjustment” for shortcomings not projected in the previous agreement ($20 million), increased costs for moving to its consolidated campus in White Oak, MD ($11.7 million), and an inflation adjustment ($17.7 million).

Share this article:
You must be a registered member of MMM to post a comment.
close

Next Article in Channel

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.