Regulatory Overdose looks at some of Alex Tabarrok’s (and Dan Klein’s) suggestions for improving FDA regulations — largely by reducing them, of course:
There’s an odd contradiction in the current FDA regime: Before marketing a drug, a company must spend years proving it’s effective for a particular condition. Yet once the FDA approves a drug for a single ‘on-label’ use, doctors are free to prescribe it for any other malady, whether closely related or not. Such off-label use is now common, with studies finding most cancer, AIDS and pediatric patients receive off-label prescriptions. ‘Off-label is almost the rule, not the exception, in this country,’ says Dr. Lawrence Reed, a Manhattan plastic surgeon.
Fans of the nanny state might prefer to bar the use of drugs for any patients or purposes the FDA hasn’t approved. 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. In Phase I trials a company studies how a drug moves through the body and its safety for human use. Then a drug enters Phase II and Phase III trials, which typically take years and focus on efficacy as well as safety. The long wait can cost lives and runs up new-drug costs — to an estimated $900 million per successful drug.
Tabarrok says this system makes little sense; the FDA demands costly, time-consuming efficacy tests for some uses and no tests for others. And while the FDA allows off-label prescribing by docs, it strictly limits the drugmakers’ promotion of such uses to doctors and permits none at all to patients.
Some other suggestions:
Of course, drugs aren’t simply safe or unsafe; all have side effects. If a drug is effective enough, even substantial side effects may be acceptable, while with minimal or no effectiveness they wouldn’t be. The present system gives a drug a green or red light after a combined review of safety and efficacy. Patients might be better off with a system that scored a drug on each attribute and let the doctor and patient make the final decision.
While Tabarrok’s proposal is radical, a recent survey of 500 doctors he carried out with Santa Clara University economist Daniel Klein revealed that 27% backed the idea. Another 15% were undecided. By contrast, just 2% favored banning off-label prescribing.
Tabarrok and Klein also offer some alternative proposals at FDAReview.org. One is to make all FDA testing optional. Drugs that didn’t go through the process would be labeled “Not FDA Approved.” Under this approach, they say, “the FDA would become a genuinely voluntary institution, much like Underwriters Laboratories.” Another idea is for the FDA to award letter grades, A to D, to claims made by drugmakers, much as it is considering doing for health claims for foods and dietary supplements. The FDA could still have its say, but wouldn’t be able to impose long delays, since a new drug could be marketed at first as “unrated.”
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.
And why isn’t big pharma fighting for these changes?
Tabarrok’s cynical view is that big pharma companies like the status quo because it drives up costs, thus forcing many entrants to sell off their discoveries to established drug companies.