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FDA ordered to address problem of drug shortages

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President Obama has ordered the FDA to work to avoid critical shortages.

President Obama is using his executive authority in directing the Food and Drug Administration (FDA) to start reducing drug shortages, and the possibility of price gouging.

Highlights

By Catholic Online (NEWS CONSORTIUM)
Catholic Online (https://www.catholic.org)
11/1/2011 (1 decade ago)

Published in Health

Keywords: Obama, FDA, drugs, shortages, health, price gouging, critical care

WASHINGTON DC (Catholic Online) - Drug shortages are a serious concern, and patients have died because of them. The most commonly affected drugs are cancer drugs, anesthetics, and drugs used in emergency medicine, as well as electrolytes needed for IVs. Typically, in addition to paying more for drugs, shortages can also cause lengthy, sometimes fatal delays in treatment for critical patients.

Currently, when hospitals experience supply shortages, they are forced to purchase replacements from secondary sources. Often, secondary sources sell the drugs at huge markups.

As drug producers manufacture critical drugs, wholesale buyers purchase large chunks of the production. Holding those drugs in storage, they wait for a shortage -- and a buyer. After stockpiling the supplies, they are then able to mark up the price of the critical drugs, and generate huge profits.

This practice is not illegal, but it is one that puts profits ahead of patient care. Medical professionals have been calling for government attention to this problem for years.

Obama has also announced that he will be supporting congressional legislation that would require that drug manufacturers notify the FDA at least six months in advance of potential shortages. Current regulations only require manufacturers to notify the FDA is medically necessary drugs are going to be discontinued. Shortage notification is currently a voluntary process.

Last year, the FDA reported 178 drug shortages and the agency says that this year the number is projected to be higher. Other shortages are caused by manufacturing problems, and other logistical delays. It is also common for drug manufacturers to stop producing certain drugs, and start producing more expensive (and profitable) alternatives.

The FDA says it supports Obama's new legislative push.

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