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Drug Shortages are Due to Inadequate Regulation of Pharmaceutical Companies


There’s an article in yesterday’s New York Times about a new drug shortage: intravenous sodium bicarbonate.  What is really ridiculous about this shortage is that most home kitchens have a supply of this most basic of drugs.  Bicarbonate is used to relieve excessive acid levels in the blood; as such, it is particularly needed in hospitals and emergency rooms to treat seriously ill patients and for open-heart surgery.

What is even more absurd is that the Food and Drug Administration has no power to alleviate or prevent this situation.  From the article:

Andrea Fischer, a spokeswoman for the Food and Drug Administration, said companies were asked to notify the agency of problems, but “there are no requirements that firms keep emergency supplies or that they stock up prior to any changes they make.”

She said the agency was in close contact with the companies and “exploring all possible solutions to this critical shortage, including temporary importation, to help with this shortage until it’s resolved.”

Ms. Fischer said the agency had recently made progress in preventing supply problems. In 2011, it tracked 251 new shortages, an all-time high. But by 2016, she said, there were only 23 new shortages. Currently, more than 50 drugs are classified as being in shortage on the F.D.A. website.

“Unfortunately,” she said, “not all shortages can be prevented.”

The bicarbonate is supplied by two major companies, Pfizer and Amphastar.  The shortage began several months ago when Pfizer acquired Hospira and changed its distribution plan from five regional centers to just one national warehouse as part of a “reorganization” (read: extraction of profits from the company that was bought out.)  When Pfizer ran low, demand increased and Amphastar was quickly overwhelmed.  Now, only large hospitals with compounding pharmacies that can produce the drug from scratch ingredients are receiving sufficient supplies.

Finally, this shortage is just one of many; currently, fifty drugs are in critically short supply, all of them cheap and readily available generic drugs.  It appears that, in the absence of adequate regulation, drug companies are skimping on quality control and maintenance at plants that produce cheap generics in order to improve profit margins and possibly create shortages that allow them to increase prices.  This problem has been nationally recognized for years: reports on shortages go back at least five years, and at one time, over two hundred such drugs were in short supply.  The FDA is using its persuasive powers with drug companies, but in the absence of competent regulation, they have no legal power to force companies to plan ahead or even notify pharmacies early.

It seems that drug companies are gung ho to produce expensive new “wonder drugs” (not necessarily better, but under patent) and not so keen to produce staple drugs that don’t allow for high profit margins or benefit from advertising to push consumers to demand brand names.  This is just one more example of why health care does not go well with unregulated capitalism.  Capitalism works well in selling breakfast cereal but not so well when supplying materials and services that everyone needs, can’t live without, and can’t always afford to pay a premium for.


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