Paging Dr. Tabarrok: Off the Fast Track at the Fda

Michael Giberson

When I read about this news story about the FDA from the Cleveland Plain Dealer, I immediately thought of (FDA critic) Alex Tabarrok. Googling “FDA Tabarrok fast track” brought me to “Regulatory Overdose” at Forbes:

But George Mason University economist Alexander Tabarrok has a different idea: Abolish FDA-required efficacy testing altogether. Such testing is a big reason it typically takes 10 to 15 years from the time a new drug is discovered until the FDA approves it for sale….

At the least, Tabarrok argues, the FDA should permit drug companies to sell any drug that has been approved by other sophisticated drug regulators, such as those in Canada, Australia or the European Union. Under such a system U.S. patients would get speedier access to new medicines without losing out on safety protection.

So are drugmakers jumping up and down promoting Tabarrok’s ideas? Nope. “Our thought is, ‘If it ain’t broke, why fix it with a new scheme?'” says Jeffrey Trewhitt, a spokesman for the Pharmaceutical Research & Manufacturers of America. He adds, “The system has been made more efficient, and it certainly is the regulatory gold standard of the world, and we’re comfortable with it.”

… An FDA spokesman, for his part, emphasizes that agency initiatives such as “fast track” have made approval faster than it used to be and argues that drugmakers could be exposed to greater liability risk with less FDA regulation.

Tabarrok replies that the drugmakers don’t seem to get much protection from the trial lawyers anyway, even with FDA approval.

And, according to the Cleveland Plain Dealer, fast track hasn’t made things any faster. In fact, says the newspaper, all it produces are a few short term trading opportunities for folks watching the agency announcements.

“It doesn’t change the process of the drug, the potential of the drug or the probability of the drug’s success. On a fundamental basis, Fast Track designation means absolutely nothing to me as an analyst,” [biotech business analyst Reni] Benjamin said. “A Fast Track designation, frankly, is noise and an opportunity to take some profit.”

(HT to The Science Business blog at Forbes.)