FDA continues to fight drug shortages in U.S.
February 21st, 2012
01:35 PM ET

FDA continues to fight drug shortages in U.S.

In response to President Obama's executive order to help prevent future drug shortages, the Food and Drug Administration Tuesday announced a series of steps to increase the supply of two critically needed cancer drugs: Methotrexate, a drug used to treat children with leukemia and some adult cancers, and Doxil, used to treat numerous forms of cancer from lung to ovarian. Doxil is also used in AIDS-related Kaposi's sarcoma and multiple myeloma.

"Through the collaborative work of FDA, industry, and other stakeholders, patients and families waiting for these products or anxious about their availability should now be able to get the medication they need," said FDA Commissioner, Dr. Margaret A. Hamburg.

Because there were critically short supplies of both drugs the FDA is taking steps to increase available supplies for U.S. patients.

Doxil, at this time will be replaced by Lipodox, a drug similar to Doxil, which is expected to end the shortage and fully meet patient needs in the coming weeks until more Doxil is available.

Lipodox is manufactured overseas, and has not been approved by the FDA. The FDA's importation of Lipodox is temporary. Temporary importation of unproved foreign drugs is usually considered in rare cases when there is a critical shortage of an approved drug in the United States and the shortage cannot be resolved quickly with FDA-approved drugs. When a foreign company is identified and is able to import the needed drug, FDA evaluates the foreign-approved drug to ensure it does not pose any risk to U.S. patients.

As for methotrexate, the FDA has approved a new manufacturer of a preservative-free form of methotrexate that is expected to boost the supply. The manufacturer, APP Pharmaceuticals, expects its methotrexate product to become available next month and continue indefinitely.

The FDA also is having Hospira, a pharmaceutical delivery company, release additional supplies, resulting in 31,000 vials of new product - enough for more than one month's worth of demand. FDA is also working with other manufacturers of methotrexate, who have stepped up to increase production in order to meet patient needs.

"It's tough enough going through a serious illness, but not being able to have the drugs to treat (the illness) is devastating," said Sara Stuckey, mother of Nate Stuckey, a 6-year old cancer patient who's now being treated with methotrexate. Stuckey was an attendee at Tuesday's FDA press conference.

"The actions announced today will help to boost the supply of some of the most badly needed cancer drugs by patients across the country," said  Dr. J. Leonard Lichtenfeld, deputy chief medical officer of the American Cancer Society. "It is critical that the FDA ensure that the added supply of these drugs is safe and made easily available to the patients who urgently need them."

The FDA also announced it has issued draft guidance to drug industries on how to file mandatory and voluntary notifications to the FDA on possible shortages or supply disruptions of drugs, so that the FDA can act on the possible shortage as early as possible.

"It's a who, what, where, when outline on how to get the word out early to the FDA, so that no one goes without their treatments," noted Hamburg.

Since President Obama signed his executive order in October, directing action to help further prevent and reduce prescription drug shortages, the FDA claims it has prevented 114 drug shortages.

In October, the Obama administration also announced its support for bipartisan legislation that would require all prescription drug shortages to be reported to FDA and would give FDA authority to enforce these requirements. Congress has not acted on that legislation.

soundoff (48 Responses)
  1. larry5

    The FDA is nothing more than a trade union organized, staffed, financed and run by the very people they are supposed to regulate. If a patient dies because of FDA politics is just a distraction from the real business at hand. These are important and powerful people here. Don't think you can side track them with such petty details.

    February 21, 2012 at 14:54 | Report abuse | Reply
    • Non

      Curious, then, that it takes so much longer to gain regulatory approval in the US via the FDA than in, e.g., the EU via the EMA. Sorry, try again..................

      February 22, 2012 at 07:21 | Report abuse |
    • Non

      Curious, then, that it takes so much longer to gain regulatory approval in the US via the FDA than in, e.g., the EU via the EMA. Sorry, try again.

      February 22, 2012 at 07:21 | Report abuse |
  2. htv834

    And the rest of the story... Drug companies aren't interested in manufacturing off patent drugs. The big money lies in charging hundreds or thousands of dollars for the newer medications. Yet another example of runaway corporate greed. Too bad Congress can't regulate common sense and decency.

    February 21, 2012 at 18:41 | Report abuse | Reply
    • Non

      OK, Sparky. Let's see you put your money where your mouth is. Why don't you start manufacturing drugs under cGMP regulations and then sell them for less than cost, if it is such a good business model? If there were money to be made manufacturing these old, off-patent drugs, you know perfectly well someone would do it. The government has placed de facto price controls on these and other drugs through their system of "formularies" and required rebates. No company can be forced by the government to make a product and sell it whether profitable for them or not. In this case, an entire industry has said "no thanks."

      February 22, 2012 at 07:18 | Report abuse |
    • Adonis

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      April 9, 2012 at 00:29 | Report abuse |
  3. MOM

    I am posting a comment as to health insurance. My son is 25 years old and has asbergers, bipolar, and has add and had various auto/motorcycle accidents and head trauma. He is in need of physical therapy, further tests, treatments, medications and all self pay because he does not have health insurance because he cannot work because he cannot get the medical care he needs due to the cost. We were told today by a self pay pain management doctor that he cannot give my son pain medication any longer due to he has to be treated (therapy, surgery, shots, emg, ect) and we cannot afford. Credit cards maxed. Now my son is going to be strung out detoxing and not able to function due to no medication since he has been on major medication for a year now. We went to his office with results from a self paid MRI, and history from childhood forward. Have applied for medical assistance and my son was denied. Applied for Social Security and naturally that takes awhile. He wants to live a normal life, but we can't seem to get the medical care he needs either for mind or body. What now.

    February 21, 2012 at 20:23 | Report abuse | Reply
    • Jean

      If he's 25 he can be on your insurance until he is age 26, which is a change made possible under the federal Affordable Care Act.

      February 22, 2012 at 11:04 | Report abuse |
  4. sara

    To MOM–He sounds like a good candidate for SSI and subsidized drug programs for low-income patients. Your state if you're in the US has many assistance programs. What did you mean by "medical assistance"? There may be many options there. There are social security disability attorneys who can help get you through the application and approval process at relatively low cost and also find ways to get SSI.

    At 25 depending on other things he should be eligible for Medicaid to take care of basic needs if he isn't employed.

    There are charities and state agencies whose job is to help him. You don't have to figure it all out yourself. Try the state rehab office, the vocational rehab office, and social workers attached to whatever hospitals have treated him.

    February 21, 2012 at 20:42 | Report abuse | Reply
  5. Fitty.Cent

    He can always get pain Meds on the city streets, but they are all self pay too unfortunately. But, no Rx needed

    February 21, 2012 at 20:59 | Report abuse | Reply
    • pharmtechie

      Yeah, that wouldn't be too smart there brainiac. The "patient" wouldn't really know what they are getting. Not to mention what other meds they are getting legitimately.

      February 23, 2012 at 02:45 | Report abuse |
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  8. W.B.

    pathetic. this so called "shortage" is NO accident. FDA has a reason for everything, and it's NOT for the health of people. you want ONE of many cures for cancer. cannabis oil. oh wait...no side effects, a real cure for disease, millions times better that chemo, no profit in it, never will see it... SUCK IT FDA.

    February 26, 2012 at 10:17 | Report abuse | Reply
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    My mother was diagnosed with ovarian cancer and started taking chemotherapy drugs(platinum based) until her body showed an allergic reaction. She was then started on Doxil, and after only one month, her results were miraculous. In fact, her doctor actually told her that she was the 'poster child' for this wonderful drug. He told her she could take it forever, if needed, because Doxil was different from other more traditional chemotherapies. Two months later, Doxil was not available, and the doctors were given several different reasons by Johnson and Johnson, ranging from "the machine that makes the drug broke down" to 'the FDA shut the factory/facility down due to an unclean environment". Each week, though, they said, 'We should be up and running next month." My mother's health continued to worsen, and she went from a woman who KNEW she was going to live, to a woman dying at the hands of the FDA's policy? Johnson & Johnson's horrible business practices? Greed of a HUGE corporation? I go to bed every night feeling sickened to death that we live in the United States where an FDA approved, life saving drug was simply shut off and there was nothing I could do to save my mother. My bitterness goes beyond belief and when asked at the local grocer to donate a dollar for Breast Cancer Awareness Month, I simply laugh and say, 'nope....I will never give another dime to cancer anything until this country fixes its policies of replacing life saving drugs IMMEDIATELY when a company that holds the patent is no longer able to make their drug'. My brother and I have decided to investigate and take action for this cause so that our mother's death will not be in vain.

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