FDA -- Maybe not so bad after all?

  • by: |
  • 10/13/2006
From today's edition of the Wall Street Journal ...

Faster FDA Cures

Whoever controls Congress next year, the Food and Drug Administration is sure to be a political battleground. The controversial Prescription Drug User Fee Act of 1992 is scheduled for reauthorization, and the conventional political wisdom holds that the FDA is too "cozy" with Big Pharma and thus overeager to rubber-stamp dangerous new drugs.

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.

In monetary terms, the authors estimate that the law improved consumer welfare by as much as $19 billion. But more importantly, they found that more rapid access to beneficial drugs saved between 180,000 and 310,000 "life-years." By contrast, assuming that every risky drug withdrawn in that period was the fault of the Prescription Drug User Fee Act produces an upper-bound estimate of only 56,000 life-years lost.

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 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."

But despite these sensible observations, the IOM still wants more regulation. Among its recommendations are vastly increased levels of post-approval 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 new-drug advertising and tighter conflict-of-interest 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 evidence-based 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 high-profile Vioxx panic, the FDA is far more likely to kill by depriving you of a drug than allowing you to take a dangerous one.

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

Blog Roll

Alliance for Patient Access Alternative Health Practice
Better Health
Biotech Blog
CA Medicine man
Cafe Pharma
Campaign for Modern Medicines
Carlat Psychiatry Blog
Clinical Psychology and Psychiatry: A Closer Look
Conservative's Forum
Club For Growth
Diabetes Mine
Disruptive Women
Doctors For Patient Care
Dr. Gov
Drug Channels
DTC Perspectives
Envisioning 2.0
FDA Law Blog
Fierce Pharma
Fresh Air Fund
Furious Seasons
Gel Health News
Hands Off My Health
Health Business Blog
Health Care BS
Health Care for All
Healthy Skepticism
Hooked: Ethics, Medicine, and Pharma
Hugh Hewitt
In the Pipeline
In Vivo
Internet Drug News
Jaz'd Healthcare
Jaz'd Pharmaceutical Industry
Jim Edwards' NRx
Kaus Files
Laffer Health Care Report
Little Green Footballs
Med Buzz
Media Research Center
More than Medicine
National Review
Neuroethics & Law
Nurses For Reform
Nurses For Reform Blog
Opinion Journal
Orange Book
Peter Rost
Pharm Aid
Pharma Blog Review
Pharma Blogsphere
Pharma Marketing Blog
Pharmacology Corner
Pharmaceutical Business Review
Piper Report
Prescription for a Cure
Public Plan Facts
Real Clear Politics
Shark Report
Shearlings Got Plowed
Taking Back America
Terra Sigillata
The Cycle
The Catalyst
The Lonely Conservative
Town Hall
Washington Monthly
World of DTC Marketing
WSJ Health Blog