Improving the FDA

by Elizabeth Nolan Brown

I have no shortage of criticisms of the Food and Drug Administration. Where I fall short, I’m always embarrassed to admit, is solutions. What can be done about this largely useless, sometimes harmful, and occasionally beneficial agency? Economist Alex Tabarrok has some thoughts:

One key reason for Europe’s efficient approval process is that European governments don’t review medical devices directly. Instead they certify independent “notified bodies” that specialize and compete to review new products. The European system works more quickly than the U.S. system, and there is no evidence that it results in reduced patient safety. Rather than tweak the current system, why doesn’t the U.S. just adopt the European model and call it a day? Our health and our economy would be better off for it.

In addition to “becoming a certifier of certifiers as is done in Europe,” Tabarrok suggests we not reinvent the wheel with every approval. If we believe the testing standards of certain other countries are sound, drugs and devices approved there could be provisionally improved in the United States.

Tabarrok recently reviewed Joseph Gulfo’s Innovation Breakdown, a book about (according to the subtitle) “how the FDA and Wall Street cripple medical advances.” Gulfo is the former president and CEO of MELA Sciences, a medical device company focused on improving skin cancer detection. One of MELA Sciences’ products is MelaFind, a melanoma detection device designed for dermatologists’ use. But MelaFind almost didn’t make it to the market – after an extensive clinical trial to the FDA’s specifications, the agency then came out against MelaFind.

Here’s Taborrok on the dramatic conclusion:

The climax to this medical thriller comes when, in “the greatest 15 minutes of [his] life,” Dr. Gulfo delivers an impassioned speech, à la “Twelve Angry Men,” to the FDA’s advisory committee. The committee voted for approval, 8 to 7, and, perhaps with the congressional hearing in mind, the FDA approved MelaFind in September 2011.

Despite all this, Gulfo still believes in the need for a strong FDA; Taborrak says he’s wrong, wrong, wrong. Reihan Salam seems interested by skeptical and points to a proposal similar to Taborrok’s from Hoover Institution fellow Henry I Miller:

… Miller calls for a U.S. commitment to accepting the judgments of select foreign regulatory authorities with strong reputations for protecting the interests of consumers, like those found in the European Union, Canada, and Japan.

More controversially, Miller suggested in a 2001 proposal that certified, independent bodies would handle evaluating new drugs and devices—but these bodies would be hired directly by pharmaceutical and medical device companies. “One obvious concern,” writes Salam:

… is that biotech firms might hire unscrupulous, low-cost drug-certifying bodies that do a slapdash job. Yet these bodies would presumably fail to pass muster with the FDA, which would continue to serve as the last line of defense. The desire to hire the cheapest and most compliant drug-certifying bodies would have to be balanced against the desire to hire a body that will get its decisions approved.

For more ideas on improving the FDA, see here and here.