Why Are Some Prescription Drugs So Hard to Get?

If you have some types of cancer and your treatment includes chemotherapy, theres a good chance youll be prescribed the drug Doxil. If your doctor can get her hands on any, that is. Doxil is one of many crucial drugs thats in seriously short supply.

Just take a look at some posts to a message board for cancer patients: The doctors office called to say no Doxil available anywhere. I managed to get two rounds of Doxil in for my recurrence [of ovarian cancer] but its not looking likely for round three. It turned out the Doxil I was so afraid of was not available. Those are just a few comments posted online at the Ovarian Cancer National Alliances site by women with ovarian cancer facing a shortage of the drug.

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And they help to explain the elation in the cancer community earlier this week when the Food and Drug Administration (FDA) announced that it had expedited approval of a generic version of Doxil (doxorubicin hydrochloride liposome injection) to help fill this great need. Until the company making the generic version is able to ramp up its manufacturing, the FDA will continue to allow a version made outside the U.S. to be imported for use by patients. In addition to ovarian cancer, Doxil is also approved (and in short supply for) multiple myeloma and AIDS-related Kaposis sarcoma.

This new approval will enable thousands of cancer patients to get the much-needed drug.

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Doxil is just one of many drugs for which theres a shortfall in the U.S.; according to the New York Times, the shortage peaked in 2011 at 251 drugs. The current FDA list of endangered drugs still tops 100 and includes two versions of the painkiller morphine; the flu drug Tamiflu; and Propofol, an anesthetic linked to the death of singer Michael Jackson.

Many of the shortages are for injected drugs and the FDA says the problem is often manufacturing difficulties, since those drugs must be made in sterile facilities that can be hard to maintain. Other reasons for the shortages include scarce raw ingredients and companies getting out of the drug business. Congress General Accounting Office is looking into what impact price has had on drug shortages.

The White House issued an executive order in 2011 that requires drug manufacturers to let the FDA know if supplies of a drug look to be dwindling and the agency has introduced some strategies to ease the shortages, including allowing more drug imports and speeding up some drug approvals that can be used in place of drugs that are hard to find.

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Why Are Some Prescription Drugs So Hard to Get?