New FDA Rules regarding Drug Shortages

1-25-2014: WSJ article 1-24-2014, Page B1 reported manufacturers are coming back into developing & producing new anti-biotics after regulators have been eliminating hurdles to producing new anti-biotics and since more and more people are dying every year over ineffectiveness of current anti-biotics since many people are becoming immune to them.

Hey, Obamacare hasn’t kicked in yet so drug shortages aren’t as huge a problem until it does…when there’s no profit incentive for pharmaceutical companies to invest millions/billions into development with no hopes of making any return.

In the meantime, the FDA has established a new rule to require drug companies to report to the FDA any plans to stop production of drugs in short supply. Since 2011, almost 375 drug shortages have been prevented – it’s been a help but many shortages still exist.

Who determines what “is or isn’t but will be” in short supply is unclear to me…but most severe shortage now are those with electrolytes, vitamins, and fluids to help in resuscitation of patients and in treatment of infants.

Problems pointed out is that few companies are making these products and generics and either shut down or have a production problem reducing the quantity produced.

Side thought: Shouldn’t this have been a routine process with all drug manufacturers in trade journals or just word getting out to give other manufacturers the option to make some money?

Source: WSJ, 10-31-13, B4

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