Not All Doom and Gloom at the FDA

The report is out. With storm clouds circling the fiscal cliff, it's refreshing to present, for a change, some good news. The FDA has approved 35 novel drugs in 2012 - the same as it had in 2011 and matching the highest approval rate in roughly a decade. These approvals included 10 cancer drugs, 9 drugs for orphan diseases, and one non-oncology personalized drug for cystic fibrosis (Kalydeco).

One of the more impressive results is that nearly 70 percent of the approved drugs were approved in the U.S. first - a tribute to the FDA's efficiency compared to its international competitors, and perhaps a welcome sign that we may yet be able to maintain out innovation advantage.

In terms of approval speed, 25 of the 35 (71 percent) of the approved drugs went through one of three FDA expedited approval pathways - Fast Track, Priority Review, and the most flexible , Accelerated Approval. The drugs in these pathways had enormous success, and most were approved on the first cycle.

Under Commissioner Hamburg's leadership, the FDA beginning to dismantle some of the innovation-stifling barriers that plagued agency in the past - yet it's too early to celebrate.  . As we wrote recently, costs of drug development continue to rise, threatening the long term viability of the industry. And not all drug classes are created equal - over 50% of the FDA's new approvals were for specialty indications, rather than primary care indications like diabetes or obesity.

In other words, 2 good years in a row is a sign of good momentum for the agency and welcome news for patients, and policymakers try and build these trends.   .

In particular, and as I've written before, the FDA should use this as impetus for fresh guidance on antibiotic development, to pre-empt the growing antibiotic resistance. Reducing the regulatory barriers by easing clinical trial requirements would do wonders.

More broadly, the FDA can expand their Accelerated Approval pathway to other drugs (it was used mainly for AIDS drugs) for life-threatening conditions. This would ease data gathering requirements (companies could gather data based on a surrogate or provisional clinical endpoint without needing to have a fully validated clinical endpoint like death or irreversible morbidity), and by reducing the time to approval, drugmakers would be better equipped to recoup their R&D costs, spurring additional investments.

So two cheers for the FDA.  Let's see if there will be a hat trick next year.

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