Drug shortages hit an all-time high
December 16th, 2011
10:22 AM ET

Drug shortages hit an all-time high

Between 2006 and 2010, drug shortages increased by more than 200%, according to a Government Accountability Office report released Thursday. There were a record 196 shortages last year, and even more are expected in 2012.

“These shortages often force Americans to go without treatment,” Senator Tom Harkin said.

Renee Mosier is one of those patients who has been forced to forgo treatment and look for alternatives. The 61-year-old was first diagnosed in 2006 with ovarian cancer. After several successful surgeries and chemotherapy treatments, the cancer came back this past June.

Her doctor suggested a chemo regimen that included Doxil, one of the most successful drugs to help keep ovarian cancer at bay. The only problem? Doxil wasn’t available. It is one of the drugs on the drug shortage list, and has not been available for several months. On average, the GAO report found that most shortages last more than 9 months.

For Mosier, it’s not just about waiting for the drug. “It’s a life and death thing,” she says.

More than half of the drugs of the shortage list are considered critical, meaning there are no other alternatives for them. Doxil has no generic equivalent. The drugs most often in short-supply included anesthetics and oncological drugs.

The report pointed to manufacturing issues, such as shutdowns, and technical difficulties as being some of the biggest reasons for the drug shortages.

In addition, many drugs, like Doxil, are very difficult to technically replicate. So, once there is a shortage, it is almost impossible for another manufacturer to start producing a similar drug to relieve the shortage.

The report suggested that the Food and Drug Administration could better respond to the shortages if manufacturers were required to report to the FDA of potential shortages, allowing the FDA to find alternatives to deal with the potential shortage. Currently there is no such legislation requiring drug manufacturers to do so, and the FDA most frequently finds out about shortages from doctors and patients.

In addition, the FDA does not maintain its own drug shortage data, which would better enable the FDA to monitor trends.

A result of the drug shortage has been price gouging and the creation of a “grey market” for hard-to-find drugs. “Aggressive measures are necessary to crack down on anti-consumer practices promoted by so-called 'gray markets' that inflate prices, creating a public health menace," Senator Richard Blumenthal said. "There should be zero tolerance for profiteering or price gouging in these essential drug markets.”

President Obama did sign an executive order this past October requiring the FDA to expedite regulatory reviews of drug manufacturers and investigate price gouging.

Building on the Executive Order in October, the White House also announced on Thursday that they will immediately begin requiring some drug manufacturers to report production interruptions to the FDA. The manufacturers that have to report to the FDA are those drug manufacturers that have no generic equivalent and are critical to maintaining life.

In addition, there are currently two bills before Congress that address the issue. But while Congress tries to create some sort of solutions, patients like Renee Mosier are forced to wait.

“You just don’t expect it to happen here."

soundoff (257 Responses)
  1. mudbone9

    If drug companies can't fill the demand then they should lose their patents on the drugs. This would stop this crap from going on. As long as politicians keep taking PAC money (bribes) the laws will probably never be changed.

    December 20, 2011 at 12:21 | Report abuse | Reply
  2. iceload9

    "begin requiring some drug manufacturers to report production interruptions to the FDA" That sounds scary. This is the same FDA that's in the pocket of the big pharma. The healthcare industry is beginning to split at the seems. The money is running out. They can't run back to the middle class anymore, their broke.

    December 20, 2011 at 12:42 | Report abuse | Reply
  3. Katie

    It's in the governments best interest to keep people as sick as possible. Same for the drug companies.

    December 20, 2011 at 12:59 | Report abuse | Reply
  4. Trin

    Why doesn't she get some Doxil from a different country? Or get treatment in another country? The U.S. is so far down on the list of healthcare that it's barely worth seeking treatment here. Our facilities are outdated (bar a few flagship centers in the country who have $$$billions to splash around), our professionals are generally from foreign countries already, and providing access to healthcare is the bottom priority.

    December 20, 2011 at 13:43 | Report abuse | Reply
  5. timmy

    if people were allowed to self medicate, we wouldn't have a prescription drug shortage.

    December 20, 2011 at 14:44 | Report abuse | Reply
  6. Myto Senseworth

    Most physicians are just professional pushers for big pharmaceutical companies. They are willing to pass out drugs even if they are not needed. Not a surprise when they run short........... And Washington wants social med?!!? !

    December 20, 2011 at 15:58 | Report abuse | Reply
  7. Ben

    Katie – Nice slogan, but in what was is it in their best interest? The government also pays for the care, so that makes it seem that keeping them healthy would be in their best interest.

    Timmy – So, if people could take whatever they want, whenever they want we'd have less of a problem? Antibiotic use is out of control and is helping to breed superbugs, and that's with a (far too easy) physician needed most of the time. Your solution seems likely to make things work.

    I think that patents for drugs ought to include a provision that states that if you stop making enough for the demand, then you lose your patent. Patents exist to spur innovation in society's interests, and this is obviously not, so take that protection away.

    January 2, 2012 at 18:33 | Report abuse | Reply
  8. Elsie

    I am a clinical pharmacist in maryland and it is so sad and difficult dealing with these medication shortages. Dealing with these shortages is not only frustrating but in my opinion is preventing us healthcare providers from providing the best possible patient care. Some of the meds that are on backorder are just ridiculous. For example, zofran (anti-nausea medicine) iv, duramorph iv (morphine preservative free used for patients in labor), metoprolol (blood pressure medicine) iv. I can go on and on. The FDA must intervene immediately before patients start dying, if they haven't already. I hope that this issue remains in the media because a change must be made and it must be made now!

    January 29, 2012 at 19:29 | Report abuse | Reply
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  12. CommonSense

    The entire reason for this is government involvement. Drug companies only are incentivized to make drugs if they can make money. When that is limited, often by the government, you see these unintended consequences. Socialism and universal healthcare does not create this it creates shortages like you see in this article. This is why traditional media outlets are losing readers and money, they do not perform any real analysis on issues such as above. They just cut and paste stats and headlines with no real analysis.

    February 15, 2012 at 14:40 | Report abuse | Reply
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