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The Amendments caused the “American Thalidomide” Tragedy

The Amendments caused the “American Thalidomide” Tragedy

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by Mary J. Ruwart   Continued from, “The Amendments discourage use of tried-and-true drugs.” Ironically, the amendments, intended to prevent tragedies like thalidomide, actually caused what I refer to as the “American thalidomide tragedy.” In the early 1980s, several reports in medical journals indicated that folic acid taken early in…

The Amendments discourage use of tried-and-true drugs

The Amendments discourage use of tried-and-true drugs

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by Mary J. Ruwart   Continued from, “The Amendments steer drug companies away from natural remedies.” For the same monetary reasons described above, pharmaceutical firms usually prefer to develop new NCEs rather than gain a “secondary indication” for a compound already on the market. Manufacturers must gain a new, although…

The Amendments steer drug companies away from natural remedies

The Amendments steer drug companies away from natural remedies

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by Mary J. Ruwart   Continued from, “The secret gets deadlier.”   In addition to their costs in lives and money, the amendments created losses that are hard to accurately estimate and potentially greater than anything else discussed so far. Although they are difficult to quantify, a few examples will…

The secret gets deadlier

The secret gets deadlier

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by Mary J. Ruwart   Continued from, “Millions die waiting for life saving drugs.” By now, you’ve probably realized that excess regulation-that is, regulation that harms instead of helps-is the deadly secret behind soaring pharmaceutical prices. Unfortunately, the death toll from the 1962 amendments is not limited to their impact…

Millions die waiting for life saving drugs

Millions die waiting for life saving drugs

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by Mary J. Ruwart   Continued from, “Did the Amendments increase consumer safety?“ As mentioned earlier, the longer development times created by the amendments have adverse effects of their own. People may die needlessly because the drugs that would save their lives are still in regulatory testing. A recent study…

Did the Amendments increase consumer safety?

Did the Amendments increase consumer safety?

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by Mary J. Ruwart   Continued from, “Did the Amendments end consumer waste from ineffective drugs?“ However, consumers might be willing to pay high, even exorbitant, prices for pharmaceuticals if they were indeed safer. Were the amendments effective in increasing consumer safety? To answer this question, let’s look to the…

Did the Amendments end consumer waste from ineffective drugs?

Did the Amendments end consumer waste from ineffective drugs?

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by Mary J. Ruwart   Continued from, “Does more advertising mean higher drug prices?“ By now, it should be pretty obvious that soaring pharmaceutical prices are largely a result of the Kefauver-Harris amendments. As consumers, we might be willing to pay these high prices if it assured us of drugs…

Does more advertising mean higher drug prices?

Does more advertising mean higher drug prices?

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by Mary J. Ruwart   Continued from “Increased R&D is reflected in soaring pharmaceutical expenditures.” From the above discussion, it’s clear that the 1962 amendments play a major role in today’s soaring pharmaceutical prices and, most likely, the high profit margin that these companies offer. In recent years, pharmaceutical companies…

Increased R&D is reflected in soaring pharmaceutical expenditures

Increased R&D is reflected in soaring pharmaceutical expenditures

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by Mary J. Ruwart   Continued from, “New drug research and development (R&D) increases 13-fold faster because of the Amendments.” Does what the manufacturer pay for R&D have an impact on pharmaceutical prices? To answer that question, we can compare prescription drug expenditures in the United States with the R&D…

New drug research and development (R&D) increases 13-fold faster because of the Amendments

New drug research and development (R&D) increases 13-fold faster because of the Amendments

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by Mary J. Ruwart   Continued from, “Congress affirms that regulations account for over 80% of drug development time.” With many more years of testing wouldn’t consumers save money by buying fewer ineffective drugs? The answer, obviously, is “yes.” On the other hand, many more years of testing increase development…
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