WHO is Responsible for Drug Shortages?

CNN reports in a breathless headline: The World is Running Out of Antibiotics, WHO says.  

The article is interesting as a whole.  The article begins with a description of the problem:

Too few new antibiotics are under development to combat the threat of multidrug-resistant infections, according to a new World Health Organization report published Tuesday. Adding to the concern: It is likely that the speed of increasing resistance will outpace the slow drug development process.

While the article goes on about these drug shortages, there are no questions as to why too few antibiotics are under development and why the drug development process is so slow.  A major reason for the slow development of drugs is drug regulatory agencies like the FDA!

The purpose of drug regulatory agencies is to slow down development of drugs.  The FDA (and its global counterparts) require extensive (and expensive) testing, large sample sizes, and the like, all which slow down the development process.  If these regulations were loosened, then the speed of development would increase.

However, this is not to say reducing FDA regulations are necessarily desirable.  A cost-benefit analysis would need to be done.  Are the costs of delayed drug developments, like what the WHO complains about here, worth the benefits from the FDA regulations?  It may be, in which case the slow development will have to be accepted.  However, if the costs of the delayed development are too high and exceed the benefits of the regulation, then one would need to accept a higher risk of dangerous drugs getting through in favor of quicker drug development.

In an ideal world, we would have both quick development and safe drugs; there wouldn’t need to be a trade-off between the too.  But in this less-than-ideal world we live in everything is scarce, including time.  Every second spent doing testing and meeting regulatory requirements is one second less to spend on development of new drugs (and vice versa).

3 thoughts on “WHO is Responsible for Drug Shortages?

  1. What would be the problem with making drugs that have NOT been FDA approved available as long as they are labelled as such? If I have a desperate need for something, I may be quite happy to assume that risk. If I’m just looking for an improved Statin, I may choose to wait until the new drug has been thoroughly tested. The notion that EVERYBODY values risk identically is ludicrous. It’s why some people choose to buy earthquake coverage for their homes and some do not.

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  2. What? The FDA hasn’t done a cost-benefit analysis on their restrictions and rules? What are they doing there?

    I’ll guess. The benefit is never making a concentrated mistake that could be blamed on the bureaucrats. The cost is high prices and millions of unconcentrated deaths and disabilities which might have been helped by faster drug development. There will be no change as long as people die or suffer one by one spread over the US.

    The FDA will not change until hundreds die of an emergent bacteria in one hospital. That headline may move them a bit.

    I base my opinion in part on the FDA’s unwillingness to approve drugs which have been approved in major EU countries. It seems that the proclaimed virtues of government-run healtcare don’t extend to protecting US bureaucracies. Our bureaucracies will not import foreign knoledge about drugs. We must protect good, American jobs in government agencies.

    An irony. The FDA adopted its slow but steady approach because of the Thalidomide disaster in 1960. Thalidomide was a drug for diminishing morning sickness in pregnant women. It caused thousands of severe defects in fetal development.

    This didn’t affect the US much, because the FDA was so slow to accept thalidomide, very few Americans could use it. The FDA did not discover these defects, it was just so slow that the defects didn’t happen here.

    The result is a very long and expensive approval process in the US. Plus, there is no reasonable, approved way for testing drugs which might be taken by pregnant women, and development of pediatric drugs is even more slowed.

    Bureacracies make bad choices when the outcomes risk lives to save other lives. As
    Seattle Sam said, the individuals should decide according to their situation, not the bureaucracy covering its behind.

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