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The Prescription Drug User Fee Act (PDUFA) re-authorization wrangling is underway on Capitol Hill. Today the House of Representatives takes up its version of the FDA bill the Senate passed last week. On May 24th the Senate version of the PDUFA bill passed on a 96-1 vote. The current PDUFA will expire on October 1st and debates in the House could, potentially, take all summer. However, legislators and industry observers have expressed hope for a final bill to be presented to the President for signature in early July. We’ll be closely following the progress of the reconciliation of the House and Senate bills.

Estimates vary but the present PDUFA will likely bring in around 6.4 billion dollars to FDA over its active period. Since PDUFA fees account for the majority of the FDA’s drug review budget, the core PDUFA legislative mandate has broad bi-partisan support. While PDUFA itself is fairly non-controversial, the various amendments that were attached at the beginning of the week led to intense debate. Many of those proposed amendments – such as energy drink registration and Canadian drug importation – were dropped from the final version of the Senate bill.

Continue Reading PDUFA Working Its Way Through Capitol Hill

In today’s market, odds are that a life sciences company will end up with a corporate partner at some point in its development.
These relationships are often compared to marriages, and the parties usually enter into them with the same high expectations of living happily ever after that couples do. But in reality, partnerships between biotechnology and pharmaceutical companies are often characterized by years of “marriage counseling” while both sides try to sort out their various expectations.

Continue Reading Five Things to Think About Before Saying “I Do” to a Corporate Partner