It has been criticized many times for the past 30 and more years that the efficacy requirement is superfluous and unnecessary! Will President Trump finally do something about it in his second term!
The thalidomide tragedy/scandal with some horrifying pictures of severely deformed babies of the late 1950s/early 1960s is also very well known. However, should the wrong conclusions then still drive drug development at the end of the first quarter of the 21st century? Absolutely not!
"... Before 1962, developing a new drug took just two years; it now takes 12 to 14 years. Since 1975, capitalized drug development and approval costs have increased at 7.5% per year in real terms, doubling every 10 years. Given this growth rate, we estimate that drug development costs are now, on average, nine billion dollars per successful new drug.
Why does the process take so much longer and cost so much more? Because, since 1962, drug companies have needed to prove, to the Food and Drug Administration’s satisfaction, that new drugs are safe and effective for a particular disease or condition.
Between 1938 and 1962, drug companies were required to prove safety, but not efficacy. With our proposal, the safety requirement would still stand. Safety, after all, is the most important aspect of any drug, given that all past drug tragedies have been about safety, not efficacy. The proof of efficacy requirement—where most drug development costs, risks, and time are incurred—provides little value for patients and doctors.
Why were the rules changed in 1962 to require proof of efficacy? Some members of Congress believed that they needed to do something after a tragedy in the early 1960s in which more than 10,000 babies, mainly in Europe and Australia, were born deformed after their pregnant mothers took a sedative called thalidomide. Ironically and illogically, because of thalidomide’s safety problem the rules were changed to require proof of efficacy—a puzzling non sequitur. The FDA had been charged with ensuring that new drugs were safe for more than two decades before the thalidomide situation. Thalidomide was effective; what it wasn’t was safe. ..."
Photo of a deformed baby's feet
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