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Can We Regulate Away Drug Shortages?
A new executive order tries to do just that.


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Marc Siegel

I have a friend who has stayed alive for several years despite a life-threatening muscle cancer because of a popular chemotherapy drug called Doxil. This summer, despite being CEO of a major biotech firm, he lost access to the drug almost overnight, and he has been scrambling to obtain supplies of it ever since. When I checked around my medical center and other hospitals, I discovered that he wasn’t alone — the problem was rampant, it was nationwide, and it wasn’t restricted to only Doxil, though Doxil was certainly one of the most dramatic examples.

The problem of shortages of many of our life-saving intravenous drugs — including chemotherapy medications, steroids, seizure drugs, blood thinners, antibiotics, and cardiac-emergency treatments — has spiraled out of control.

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But when President Obama issued an executive order this past week mandating that drug manufacturers give the Food and Drug Administration advance warnings of impending shortages, it was questionable whether this action would improve a growing problem or simply shine more of a political light on it for purposes of self-congratulation. Certainly, some aspects of the order are welcome, such as speeding the review of FDA applications when people are dying, and investigating incidences of collusion and price gouging. But simply informing the FDA that there’s a shortage in advance is a bit like informing the landlord that you are coming up short on the rent.

Consider that the FDA is a major part of the problem in the first place. Consider that excess regulation of the manufacturing process of intravenous medicines generates excessive production costs. Since many of these scarce drugs are generic, or (like Doxil) about to go generic, there is very little profit in them for the manufacturer. Add to that the fact that over 90 percent of the raw materials for these drugs come from overseas and are vulnerable to delays, and you begin to understand the problem the manufacturers face.

On top of this, many of our most important intravenous medications are needed in the war theater in case of combat injuries, so they are stockpiled in military warehouses.

The number of shortages has tripled to 180 in five years, according to the FDA, and almost 100 percent of pharmacy directors surveyed by the American Society of Health-System Pharmacists said that the shortages drive up costs, pushing hospitals to the gray market, where drugs costs are inflated to at least 100 times the usual price. The American Hospital Association found that over 80 percent of hospitals had reported delays in patient treatments because of drug shortages.

So if a hand-waving executive order mandating that the FDA be informed of all shortages won’t help solve the problem, what will? For one thing, incentivizing the production of the raw materials for these drugs here in the U.S. would be a job-creating place to start. Next, exceptions to the FDA regulatory process should become available under certain life-threatening circumstances that the patients involved accept the added risk. I am certainly a believer in quality control and ensuring the sterility of drugs, but there are times when these restrictions go too far, especially when a patient’s life is on the line.

If the government is serious about playing an active role in preventing deaths due to shortages of life-saving drugs, than it can take several productive steps, including stockpiling raw materials and drugs while allowing drugs in high demand to be sold for higher prices by the manufacturer in Medicaid and Medicare.There can also be direct discussions with the military to ensure that perishable drugs such as heart medications, steroids, antibiotics, and blood thinners don’t go to waste.

The last thing we need is more executive orders leading to more regulations that further gum up the process. When lives are on the line, we need practical, business-oriented solutions.

— Marc Siegel, M.D., is an internist practicing in New York. He is a Fox News medical contributor and the author of The Inner Pulse: Unlocking the Secret Code of Sickness and Health.



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