FDA In A Slump

by Reps. Cathy McMorris Rodgers (R-WA) and Brian Bilbray (R-CA)

Published in The Othello Outlook.

Seattle Mariners slugger and 10-time All-Star Ichiro Suzuki is a career .327 hitter. So far this season, he is batting a respectable .269. To the casual observer, that's a pretty consistent and impressive record. But a close fan of the game would also suggest that this year, Ichiro is in a bit of a slump. Sports columnist Les Carpenter even points out that over a few weeks this spring, from May 19 to June 9, he was especially cold – hitting only .149.

Fans would likely say that Ichiro is indeed a great ballplayer, but something needs to be done to get his hitting back on track. Maybe he should adjust his stance a little. Possibly shift his grip on the bat. Put in a little work with the batting coach on his swing. Something's wrong and something needs to be done to get back his groove.

Ichiro has something in common with the U.S. Food and Drug Administration. Recently, a study was published by Friends of Cancer Research illustrating that, contrary to criticisms that FDA drug reviews have become increasingly slow and inefficient relative to their regulatory counterparts at the European Medicines Agency (EMA), cancer medicines have, in fact, been approved faster by the FDA than in Europe between 2003 and 2010. Indeed, the data presented in the study shows over those eight years, cancer medicines in the United States took about 182 days to approve, while similar products in Europe took almost double the time.

Those are impressive figures. And the FDA, indeed, has a strong track record in getting new cancer treatments approved, saving lives and alleviating the ravages of this dreaded disease.

But like a closer look at Ichiro Suzuki's career stats reveals the recent slump a casual observer might miss, a closer look at the FDA figures in this study reveal that aggregating the data from 2003 and 2010 hides an important trend – a slump of sorts. The figures in the study show that, starting around 2007 and 2008, there was a rather significant narrowing of the lag in cancer medicine approval times between the FDA and the EMA.

This dangerous trend seems to reflect other findings, such as in a California Healthcare Institute (CHI) and the Boston Consulting Group (BCG) study from earlier this year, which demonstrated that during the same 2007 time period, all medicines saw a similar narrowing of EU and U.S. drug approval times – from U.S. – first approval by about seven months to a practical closing of the gap.

And like Ichiro Suzuki's slump suggests the need for some work to get his hitting back on track, the trends in the Friends of Cancer Research and CHI-BCG studies suggest FDA drug approval processes are in need of work to restore their performance.

Today, it is critical that all "fans" of new medicines – the FDA, Congress, industry and, most importantly, patients – join together and acknowledge the problems suggested in these trends. We must work to improve the efficiency, transparency, consistency and predictability of agency communications, review processes and requirements to ensure safe, effective and innovative medicines get to patients who need them as quickly as possible. A delay may not mean much in the life of a cancer drug, but it may be the difference between life and death to a cancer patient.