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Durk Pearson and Sandy Shaw – 2

Kefauver amendments of 1962 the FDA simply ruled on safety. They left efficacy determinations to the marketplace, to doctors and patients. And in fact a good economist by the name of Sam Pelzman examined the record since, before and after 1962, to see whether the Kefauver Act resulted in fewer ineffective drugs, and there’s no difference in the percentage of drugs that are ineffective. But the proof of efficacy costs an order of magnitude more than proof of safety. So that’s a big part of the cost and it’s also a big factor in slowing down the availability of drugs. Another factor that really jacks up the cost of even generic drugs is the FDA’s Good Manufacturing Practices, which are 747 pages of bad manufacturing practices.

Sandy: Yeah, they have them for drugs, and they’re about to introduce them for dietary supplements.

Durk: Effectively, they prevent the use of modern techniques, such as statistical quality control, which is what turned Japanese products from a laughing stock that was synonymous with crappy quality to the best products in the world. You can not use that under Good Manufacturing Practices.
Sandy: With the Good Manufacturing Processes they actually design your plant for you. It’s a lot more than telling you how to manufacture. They tell you how your plant needs to be laid out, and where your various machines have to be located. Also, you’ll notice–and this has been the case since the 1930s–you have no 4th Amendment rights anymore. The FDA doesn’t require a search warrant in order to go in and examine your plant. They send inspectors around. Those people don’t need warrants. These are warrantless searches, and nobody’s thinking anything about them, I guess, because they’ve been around so long.

Durk: Now, the Health Freedom Act would eliminate the requirement for GMPs on off-patent, generic drugs imported from overseas. The FDA would be allowed to test them for purity, and if they meet the same purity specifications as the American drugs that the FDA has approved, then that’s it. It doesn’t allow importing drugs that are in violation of a valid U.S. patent. But what this would mean is that you would be able to get a suite of antihypertensive and antihypercholesterolemic drugs for fifty cents a day instead of five dollars a day. So this thing about the Medicare drug benefit would be irrelevant. Nobody would be screaming for help  to pay for their drugs if everyone could get everything they needed for four bits a day.

Sandy: All of the reputable economists agree that if we’re going to have regulations concerning manufacturing, then what you should have is a standard that the final product has to meet. The final product would have to meet the standard, and that would be how they would regulate it. But that’s not the way the FDA does it. Rather than that, what they have for the Good Manufacturing Practices is they design the entire process of how you do the manufacturing. It’s an incredibly complex list of regulations, and it’s probably impossible for anybody to really comply with all of them.

Durk: The thing is, the biggest barrier between life extension and people is the FDA, by far. It’s not ignorance. It’s the FDA.

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