Monday, November 18, 2013

FDA needs more authority on drug shortages

One of the more frustrating things that health care providers – including those here in our community – have experienced in recent years is a shortage of drugs to treat the sick.

The drugs that are in short supply can include life-saving drugs for cancer treatment and other critical health care. It forces doctors, hospitals and patients to either scramble for alternatives or if there are none to pay exorbitant prices for the needed drugs.

The problem began to surface around 2005 and has been on the increase since then. It became so serious that President Obama ordered the Food and Drug Administration to find a solution to the shortages in 2011. The FDA – which said there has been a six-fold increase in reports of shortages since the order – recently released a strategic plan to deal with the problem.

The first step, of course, was to identify the source of the shortages.

Some of it is believed to be a matter of greed where artificial shortages are created so that the price of the drugs can be substantially increased.

But the FDA concluded much of the problem has to do with ineffective manufacturing processes and lack of quality control, according a report by Reuters. When batches of bad drugs have to be thrown out it can cause shortages.

The FDA proposed a multiple-step solution:

• Expand early reporting requirements of shortages by manufacturers, especially for those drugs that are difficult to produce.

• "Encourage" manufacturers to improve quality control to ensure drugs that are made don’t have to be tossed out.

• Recommend companies produce and maintain an extra inventory of drugs in the event of unforeseen problems.

What seems clear to us from these proposals is that the FDA lacks any real authority to address the problem effectively beyond simply encouraging companies to do the "right thing."

If this problem is truly as serious as some health care providers say it is, then it looks like Congress and the White House may need to look at ways to provide more effective regulatory enforcement for drug makers to prevent shortages.

Perhaps simply the possibility of that will encourage manufacturers to come up with some solutions of their own.

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