FDA Drug Approvals: Credit and Blame

Gardiner Harris had a nice article in the New York Times today on the FDA's report yesterday that it had approved a near record number of drugs in 2011. The headline pretty much sums it up: FDA Officials, Hoping to Stave Off Critics, Point to Increased Drug Approvals.

Harris makes a very good observation:

For years, F.D.A. officials said little about the declining number of new drug approvals. When some industry analysts blamed government rules for the slowdown, agency officials instead blamed a decline in high-quality industry applications and a general drought in industry labs.

Now that approvals are increasing, however, Dr. Hamburg is claiming some credit by saying that the agency has lowered some approval standards -- particularly for cancer drugs -- and speeded up many of its reviews.

Asked about this apparent contradiction, Dr. Hamburg responded, "I think the point we're trying to make is that when high quality science, good applications come before us, we are able to act swiftly and surely."

In other words, for years, the agency blamed productivity problems on the industry and said that scarcity of new drug approvals was beyond their capacity to do much to fix. Now that drug approvals are up significantly, with some very strong new products on the market, they're taking credit.

But FDA drug reviews are the last stage of the drug development process. The enormous testing - up to a decade or more - and money spent during that time is what delays patient access to new products. And that process has been getting more expensive and time consuming all the time. That process is also extensively regulated by the FDA.

So faster reviews are great, once a drug application gets to the FDA. But the FDA is also part of the problem, because the cost/time equation is so heavily defined by the FDA's demands for reams of data to prove a drug is safe and effective.

So don't take credit unless you're willing to take the blame as well. And the FDA should start to take more responsibility for the problem by telling us how it's going to start driving development times down as aggresively as it does with review times - with clear and measurable metrics that we can use to evaluate the FDA's commitment and success. Not just a new strategic plan talking about it.

The costs of delayed access to newer and potentially effective drugs, are, of course borne mostly by sick patients.

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