Here’s an excellent example of deregulatory action that the right should pay more attention to: the Rehberg Amendment to the appropriations bill for, among other agencies, the Food and Drug Administration. It reads:
None of the funds made available by this Act may be used by the Food and Drug Administration to write, prepare, develop or publish a proposed, interim, or final rule, regulation or guidance that is intended to restrict the use of a substance or a compound unless the Secretary bases such rule, regulation or guidance on hard science (and not on such factors as cost and consumer behavior), and determines that the weight of toxicological evidence, epidemiological evidence, and risk assessments clearly justifies such action, including a demonstration that a product containing such substance or compound is more harmful to users than a product that does not contain such substance or compound, or in the case of pharmaceuticals, has been demonstrated by scientific study to have none of the purported benefits.
The impact of this amendment will be to stop the FDA messing about with food and drugs on the basis of anecdotal evidence, a desire for social engineering, or other feelgood motives.
Consider the case of the routine feeding of antibiotics to farm animals, which the New York Times waxed lyrical about recently in an editorial asking the FDA to ban the practice, claiming that “we pay for cheap meat by sacrificing some of the most important drugs ever developed.” This is nonsense. As my colleague Greg Conko found when he investigated this, the hard science shows quite clearly that the claimed human health effects of animal antibiotics are overblown, and that banning their use comes with significant risks of its own.
Leftists and environmentalists are furious about this attempt to rein in one of their favorite tools of social engineering, and have (of course!) made it all about tobacco. Basically, by their logic, anyone who supports the Rehberg Amendment wants to give kids cancer. Rep. Rosa De Lauro, for example, called it a “back-door effort to undercut the FDA’s authority to issue tough food and drug rules, particularly when it comes to tobacco products.”
Over the years, the FDA has become one of the biggest perpetrators of nanny-statism in the U.S., stopping all sorts of useful innovations because of slight worries or pressure-group lobbying. It’s time that the FDA was brought to heel, and the Rehberg Amendment is a great way to do that.
No, that legislation is NUTS. Because many drug clinical trials are relatively short term, many serious side effects do not become noticed until after they have been released to the marketplace and enough incidences have been reported for someone to take notice.
Self reported side effect car wrecks pile up all the time on FDA's MedWatch. And they lead to intelligent limitations on indications as well as Black Box warnings on Prescribing Information materials so the consumer can make an informed choice.
You want your liver cooked by Cymbalta or your kid trashed by Zyprexa while you were not made aware of the risk because FDA was not allowed to update the labeling?
The idea that FDA cannot act on accumulating evidence of injury without extended clinical trials (that no one will pay for) is crazy.
Iain, Big Pharma has proven itself to be a dirty business. You better think about what you wish for.
Reply to this commentLinkReport AbuseBTW, here's an example of Big Pharma at its oily worst:
External Link
Meander through the CafePharma web site to find scores of other greasy examples and then ask yourself if you want FDA emasculated.
Reply to this commentLinkReport AbuseNow, if they'd only apply their own law to their own law, which criminalizes marijuana, and use "hard science (and not on such factors as cost and consumer behavior)…"
"Consumer behavior" = rise & fall of marijuana use, etc etc.
"Hard science" = Some kind of study that shows that violence and depravity are declining as a result of criminalization of marijuana. Remember that these were the reasons the plant was criminalized back in the 1930s. No fair inventing other reasons now to justify the law.
Reply to this commentLinkReport AbuseFor everyone defending the FDA in their comments, please READ the language of the amendment. Nothing in the language restricts the FDA from using hard science, including MedWatch reports, to regulate unsafe products. The amendment does, however, require the FDA to actually USE hard science in creating regulations. Why is this even controversial? The FDA has launched a new mission to completely wipe out the availability of raw milk without ANY evidence that it's harmful. Is there one report from someone dying from drinking raw milk? Human beings have been drinking raw milk for millenia, but the FDA would have you believe this is a serious threat to the health of the American public. It is this type of unnecessary, bureaucratic interference that is stifling the economic recovery. When will common sense return to this country?
Reply to this commentLinkReport AbuseSorry, the MedWatch reports are "anecdotal" which Iain Murray condemns as being insufficiently "scientific". Murray's implication is that only side effects measured during clinical trials could be included in prescribing information.
But the kinds of trials required to surface many side effects could takes years to implement.
Murray popped off without knowing the business. It's a shame that he no doubt knows he's wrong but won't admit it. The Left does the same thing. Avoiding the obvious for stupid ideological reasons.
Oh well, maybe next time Murray read up on his subject matter beforehand so he can appear at least modestly informed.
Reply to this commentLinkReport AbuseBTW, I agree with you about the milk thing.
But drugs ain't milk.
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