takes a close look at the recent Institute of Medicine report and finds that its criticism of the FDA is less damning than the press has reported, although it still pushes for more regulation than the Journal
editors think is prudent. They also discuss a recent paper from the National Bureau of Economic Research reviewing FDA regulation.
This study deserves a lot more attention than it's been getting, since the Washington debate is dominated by bad ideas about how to make FDA regulation much more onerous. In particular, a recent report from the National Academy of Science's Institute of Medicine (IOM) is being spun as evidence that the FDA is somehow "broken" and in need of fundamental reform.
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 highprofile drug withdrawalssuch 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."
But despite these sensible observations, the IOM still wants more regulation. Among its recommendations are vastly increased levels of postapproval safety monitoring. That might make sense if the goal is making regulators comfortable with the idea of approving drugs more quickly. But that doesn't appear to be what the IOM and its cheering section want...
The IOM also proposes draconian restrictions on newdrug advertising and tighter conflictofinterest standards for FDA advisory panel members. This despite the fact that the most qualified scientists and doctors have substantial sources of private income, and despite a study by the Naderite Public Citizen group that failed to find one instance of a panel recommendation that would have changed if allegedly conflicted members had been excluded.
Most fundamentally, the IOM presents little evidence that there is even a problem to remedy. By contrast, the National Bureau authors at least attempt to put some real facts on the table. They note that the absence of other attempts at hard, quantitative analysis in the great FDA debate is "somewhat paradoxical, since despite the agency's strict adherence to evidencebased evaluation of products overseen, there is less evidence on its own safety and efficacy. Put differently, no product application would pass the FDA approval process with the quality and type of evidence that currently exists for evaluating the FDA policies themselves."
The upshot of the economists' report is that the 1992 Prescription Drug User Fee Act deserves reauthorization. But the evidence also suggests Congress should probably be looking for other ways to make FDA approvals still faster. Despite the highprofile Vioxx panic, the FDA is far more likely to kill by depriving you of a drug than allowing you to take a dangerous one.