Monday, January 04, 2010

New Year’s Resolution for Biopharma: Submit Better NDAs

It’s official. The year 2009 was better than 2008 for innovative drug developers in the US, at least by the most common measure: the number of new molecules approved by the Food & Drug Administration.

The Center for Drug Evaluation & Research approved 25 new therapies during the year—one more than 2008. That’s not a big increase, but it is the second year in a row of higher approval totals. That is just one of many reasons for innovator companies to feel good about the improving new drug review process heading into 2010. (You can read the first of several installments about the state of the new drug review process in the US in The RPM Report, here.)

Drug development companies should feel good about the increasing approval tally—especially since it comes at a time when FDA’s reviewers were missing deadlines set by the user fee program.

But they should also take to heart the advice of Office of New Drugs Director John Jenkins during The RPM Report’s FDA/CMS Summit for Biopharma Executives last month. Jenkins, to put it bluntly, thinks industry should submit better applications. In his view, too many new drug applications are filed prematurely to meet a sponsor’s internal goals, all but guaranteeing that a review will end with a complete response letter rather than an approval.

In Jenkins’ view, if sponsors put together a more thorough, complete application—dotting all the “I”s and crossing all the “T”s—a first-cycle approval would be more likely. So, Jenkins says, taking a few extra months preparing to file would pay off with an earlier launch.

Now, it is safe to say not everyone in industry agrees that sloppy applications are a reason why many applications go through more than one review cycle. But a lot of folks in regulatory affairs know it does happen, and we know for certain of at least a few cases that look black-and-white.
You can read more about Jenkins’ views in “The Pink Sheet” here, and we'll take a deeper dive in the January issue of The RPM Report.

But for now, we’d encourage innovator companies to take advantage of the New Year to make a new resolution: make sure your internal filing deadlines encourage earlier launches—not earlier submissions.

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