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WANT BETTER AND CHEAPER DRUGS?

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The most monumental mistake of George W. Bush’s first term was his Medicare Prescription Drug bill. You have read that it is going to cost American taxpayers an estimated $6 trillion. That’s more than the entire current federal debt. But – it is much, much worse than that.

Let’s begin with the asinine assumption that in order for the cost to be only six trillion over the next 40 or so years, average American life expectancy will increase by just two years. For the last 125 years, life expectancy in America has been increasing by three months per year. For the last 30 years, as infant mortality rates have shrunk to be statistically marginal, all of the increase has gone to the elderly. By 2050, Americans will be living at least 11-12 years longer than today – which doubles the time folks will collect Medicare (and Social Security) benefits.

So now we’re at twelve, not six, trillion in prescription drug costs alone. Yet we are just getting started. The other brain-dead assumption of the CBO (Congressional Budget Office) is that drug demand and costs will remain the same in constant dollars. Any private non-government economist could have patiently explained to the CBO that when you subsidize something, the demand and thus the cost will skyrocket. There will be fantastic increases in the cost of specific “wonder” drugs – and the number of such drugs costing over $10,000 a year each will proliferate. George Bush’s bribe of prescription drug “benefits” for old folks who still refused to vote for him in the numbers he expected is going to cost our kids and their kids well over 20 trillion dollars.

I can tell you what the solution is – but unless you’re a fan of Milton Friedman and Ludwig von Mises, economists who fully understand how government regulation can ruin a market sector, it will take getting used to.

The solution is to abolish the FDA.

There is no other solution to runaway prescription drug costs. If you want better, cheaper prescription medications and more of them, abolish the FDA.

The Food and Drug Administration should be called the Federal Death Administration. It now takes on average 8-10 years and costs $800 million to get one new drug approved and on the market. Drugs that could have saved countless lives by being on the market earlier were delayed for years. Drugs that could have saved countless lives have never been on the market at all because of the FDA’s approval process.

This also applies to a new use for an existing, already approved drug – aspirin, for example. By 1988, it was well established that taking one to one-half an aspirin a day greatly reduces the risk of heart attack. For years the FDA threatened any aspirin manufacturer with jail and fines if they advertised this fact – and it continues to place certain restrictions on such advertising today. The FDA has killed hundreds of thousands of Americans since 1988 with this restriction alone.

Getting rid of the FDA will not be easy and will take years, costing the lives of ever more Americans. There is one first step, however, that could be done quickly. More than any other single thing, this would dramatically reduce both the cost and time for FDA drug approval. It’s repealing the Effectivity Clause, otherwise known as the Kefauver Amendment.

Estes Kefauver was a Senator from Tennessee better remembered for being Adlai Stevenson’s vice-presidential running mate in 1956. He stayed in the Senate and in the wake of the Thalidomide drug scandal in 1962, he sponsored an amendment to FDA regulations requiring that a drug must be proven not only safe but effective at treating a specific medical condition.

Sit down while you read this: Over 90% of drug approval costs are to prove effectiveness; less than 10% are to prove safety. In a study published in the Summer 2004 issue of the journal Regulation, researchers Daniel Klein and Alexander Tabarrok concluded that eliminating proof of efficacy and proving safety alone would reduce the costs of FDA approval from $800 million to $50 million per drug. Instead of taking 8 to 12 years, drug approval would take on average 2-3 years.

It’s not just that repeal of the Kefauver Amendment would dramatically reduce the costs and time-to-market for drugs, but it would open the market up to greatly increased innovation and competition from small drug companies that cannot afford the hideously high approval costs.

Which is precisely why the major pharmaceutical companies oppose repealing Kefauver.

The cozy corrupt collusion between the FDA and the big drug companies protects them from competition. Only they can afford the current approval process, and they want to keep it that way.

But Congressman Dana Rohrabacher doesn’t. “Let doctors working with their patients determine if a drug works or not,” he says. “That’s not the FDA’s job. The FDA’s job should be determining drug safety, period.”

Last year, he introduced a bill, H.R. 2544, the “Medical Independence, Privacy, and Innovation Act,” which, if enacted, would eliminate the Effectiveness Requirement from FDA regulations. As soon as Congress begins its 109th session at the end of this month, he’s going to introduce it again.

What Rohrabacher and the Red Dogs, a group of renegade conservative Republicans, are also going to do is collude with a number of Democrats to get it passed.

There are a number of Congressional Democrats smart enough to realize this issue is a perfect end run around Bush Republicans. It puts the Democrats on the side of the Little Guy – in this case, small entrepreneurial drug companies – and the Bushistas on the side of the big greedy pharmaceuticals colluding to prevent competition.

Now if these Dems were really smart, they would realize this is a winning stand they can take across the board – championing small business in the face of giant corporate bureaucracies using onerous regulations to hamstring competing entrepreneurs. There are House Democrats this smart – like Collin Peterson of Minnesota. But there aren’t enough of them by a long shot.

There could be enough of them on this issue, though, enough to get Denny Hastert’s attention. Transforming the FDA from a drug approval agency to a drug certifying agency (something like an Underwriters Laboratories) may be in the far distance. But this 109th session may be when it dawns on Capitol Hill – and maybe even the White House – that repealing the Kefauver Effectivity Amendment is the quickest and surest way to get better, cheaper, and more plentiful medications to suffering Americans.