Make the FDA Worse

Now that I have said not-unkind things about the FDA, the WSJ Ed Page points out that it could get a lot worse under a Democratic Congress. Democrats, for some reason I don't completely grasp, like to "FIGHT!" the pharmaceutical companies that are trying to improve our lives. It seems the evil drug firms want to make money or pay bills or return capital to shareholders or something unseemly like that. I won't know until the big Michael Moore documentary comes out.

The WSJEdPage reports that a 1992 law that allowed companies to pay the FDA for faster reviews will itself be reviewed, sadly by a Congress that may want to prove how tough it is on Big Pharma.

So allow us to draw attention to an important and undernoticed study, "Assessing the Safety and Efficacy of the FDA," published by the National Bureau of Economic Research. Its surprising conclusion is that the FDA does a pretty good job managing "the central speed-safety trade-off" involved in drug approvals -- and might even do well to move faster.

The authors looked at 662 drugs approved between 1979 and 2002, a period that included the passage of the Prescription Drug User Fee Act that allowed drug companies to help fund the FDA budget in exchange for faster reviews. They found that the resulting modest gains in drug review times have produced unambiguous public benefits.

Not that Democrats are needed to make things worse. If Senators Grassley and Dodd are teaming up, you can bet it ain't gwine be pretty. Even a competing and unflattering study thinks they go too far.

We've looked at the IOM report in detail, and it's hardly as damning of the FDA as media reports suggest. For example, the report explicitly rejects the idea that high-profile drug withdrawals -- such as Vioxx -- "represent de facto failures of the drug safety regulatory system. . . This is not so." The IOM also rejects the basic idea behind legislation sponsored by Senators Chuck Grassley and Chris Dodd that the FDA should have a drug safety office separate from the office that approves drugs in the first place: "Risk and benefit cannot be considered in isolation from one another."

Amen. The FDA sees too much risk and not enough benefit.

Pharmaceuticals Posted by John Kranz at October 13, 2006 11:17 AM