Could Drug Shortages Affect You?

July 8, 2011

This summer hundreds of drugs are on back-order or facing other serious delays. Heart patients, cancer patients, and anyone with a serious medical condition are or maybe at risk.

For a list of the drugs currently delayed, check the FDA’s website here.

When will drug shortages end?

Simple answer: many of the drugs currently unavailable are estimated to become available again by the end of the summer.

Hard answer: drug shortages have become an increasing problem over the last few years. Increasing FDA regulations are causing delays, as well as raising costs and barring certain manufacturers from the market. (For a report on how FDA policies and other factors are affecting drug shortages, Click Here-PDF).

While FDA rules are supposed to protect consumers from contamination, mis-labelling, and other dangers, some of the new rules are creating bureaucratic obstacles that are impeding drug production.

For example companies must file for approval with regard to how much of a given drug they are going to produce over a given amount of time. If demand goes up, due to an unexpected increase in illness, new discovery, or a competitor getting shut down, it can not be met. To increase production, the company must file again for permission. This and other rules have slowed down drug production to the point where patients’ needs cannot be met.

Another problem is that these regulations target pre-1938 drugs, which have been safely used for decades (or centuries), but which the FDA is tightening control over. Although not in shortage, aspirin is a good example of a pre-1938 drug that would never be approved today.

What do you think about the drug shortages? Let us know in the comments!

{ 4 trackbacks }

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