What's the alternative?

John Stossel
Posted: Jun 08, 2005 12:00 AM

Last week, I wrote about a federal agency that most people think is indispensable. In reality, I said, the FDA regulates us to death, literally, by forbidding even dying Americans who can't be helped by established medical treatments from trying innovative therapies.

 But what's the alternative? Have no oversight? Let any company peddle every dubious medicine to an unsuspecting public? That sounds terrifying. Snake-oil sellers would sell all kinds of harmful stuff. That's why we created the FDA in the first place.

 But wait a second. Snake oil sellers sell it anyway. I've done consumer reports on snake-oil sellers for years. Crooks and deluded optimists sell useless baldness remedies, breast enlargers and diet products while the FDA is supposedly in charge. The FDA rarely stopped even the obvious crooks. What it mostly stopped, or delayed, were the serious drug companies' attempts at genuine innovations.

 Without an FDA, how would doctors and patients know which drugs were safe and effective?

 The same way we know which computers and restaurants are good -- through newspapers, magazines and word of mouth. In a free, open society, competition gets the information out, and that protects consumers better than government command and control.

 Why must we give big government so much power? Couldn't FDA scrutiny be voluntary and advisory? Companies that want government blessing would go through the whole process and, after 10 or 15 years, get the FDA's seal of approval. Those of us who are cautious would take only FDA-approved drugs.

 But if you had a terminal illness, you could try something that might save your life. You could try it without having to wait 15 years -- without having to break your country's laws to import it illegally from Europe -- without sneaking into Mexico to experiment in some dubious clinic. If I'm dying, shouldn't my government allow me the right to try whatever I want?

 If FDA scrutiny were voluntary, the government agency would soon have competition. Private groups like Consumer Reports and Underwriters Laboratories (UL) might step in to compete with the FDA. The UL symbol is already on thousands of products. No government force was required. Yet even though UL certification is voluntary, its safety standards are so commonly accepted that most stores won't carry products without the UL symbol.

 With such competition, the FDA might devise a ratings system ("general use," "medical guidance suggested," "patients strongly cautioned," or something like that), and drug packages would carry that information. We'd know that the government was evaluating new drugs, but government wouldn't stand between lifesaving treatments and us. Most of us, most of the time, would take the government's advice, but because it would be our choice, we could try new or risky drugs when nothing government-approved was available.

 We could try a system where the FDA would review all drugs, but its approval wouldn't be needed for a drug to be sold. Private organizations might go into competition with the FDA even if its review remained mandatory. If a new drug is going to be "not yet rated" by the government for 15 years, the endorsement of an independent evaluator -- even one not quite as strict as the FDA -- that can deliver its opinion in three years would be valuable. Under today's FDA rule, consumers assume big government takes care of the whole issue, so we become less vigilant. The consumer is encouraged to stay asleep: Don't ask questions; just take what Big Brother approves. Yet, knowing what we know about the incompetence of government monopolies, there's little doubt that competing private groups would do the testing better, cheaper and quicker.

 Any kind of FDA has its price. If all drugs have to be reviewed -- even if they can be sold while under review -- the cost in money and energy will keep some drugs off the market. But getting rid of the FDA's power to forbid us to try something would be a big improvement: It would mean Americans would no longer be forced to wait, and die while their government passes judgment on innovations that could save them.