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This has not made nearly enough news. A crucial chemotherapy drug is now in very short supply. Johnson and Johnson, the company that owns the drug, said way back in June, that the shortage was caused by equipment problems at the third party manufacturer.  Nearly a year later, the problems remain unremedied, and now a strict rationing program has been implimented. From “Important Updates on DOXIL Supply Shortage:”

  • To continue to maximize available product, we will fax instructions and a form titled, “Confirmation of Active Patient Status and Patient Re-enrollment” to physicians with patients in the program starting at noon Eastern time on Monday, April 9, asking them to reconfirm their current allocation for each patient by 8:00 p.m. Eastern time on Monday, April 23, 2012. They can place their order by responding to the monthly re-order form sent by Janssen Products or via their usual purchasing channel.If onfirmation is not received or their order is not placed by the April 23 deadline, we regret the unconfirmed enrollment will be opted out of the program so product can be allocated to other patient re-enrollment requests. It is critical for physicians to take this step to reserve their next order for program patients...

Physicians who determine a patient is receiving clinical benefit may request up to seven (7) cycles of DOXILto  continue the patient’s course of therapy. We encourage patients to follow up with their physicians with any questions about their current allocations and/or about re-enrollment before April 23, 2012. We regret we cannot respond to patient requests for enrollment or individual enrollment status, as only a physician can request DOXIL® on behalf of patients.

Regrettably, we are not able to provide estimates for how long it will take for a patient to receive allocation of DOXIL®. Since no product is currently being manufactured, availability of this supply depends upon utilization of product currently in circulation. Re-enrollment is not a guarantee product will be available within a certain timeframe.

When do doctors have time to practice actual medicine anymore?  And think about the toll on sick patients having to keep on top of whether they will be able to receive their medicine!

So, an efficacious drug will not be available to patients who need it because the manufacturers can’t get their act together.  (According to Fox Business, new supplies won’t be manufactured until the end of the year!)

There has not been nearly enough media on this. had a good two part series that helps explain what is going on. From “Inside America’s Drug Shortage:”
What accounts for the widespread shortfalls? And why now? The FDA says 54% of the shortages in 2010 were due to manufacturing problems that led to temporary or permanent plant shutdowns. Drugmakers, while acknowledging that quality-control issues contribute to supply interruptions, point the finger back at the FDA. The agency is responsible for overseeing drug manufacturing safety and quality, but it lacks adequate funding to hire reviewers to look at companies’ applications for new manufacturing facilities and processes or to send inspectors to existing plants in a timely way. Its bureaucracy adds to delays in approvals for new facilities or manufacturing processes, which can run a year long; meanwhile, lags in new drug approvals also continue, leaving the drug supply in jeopardy.

Others cite the government’s tight price controls on generic drugs — particularly those paid for with Medicare and Medicaid — which slim down profit margins for manufacturers. Neither the government nor drugmakers subscribe to this explanation, but the argument goes that diminishing profits motivate drugmakers to abandon generics in pursuit of more profitable, patented products and de-incentivizes them from investing in better manufacturing technologies for generics. Both problems mean production of important drugs can grind to a halt when the slightest quality issue or financial glitch disrupts the system.

As I said in discussing the growing problem of chemotherapy shortages in an earlier post, the free market is not the answer to everything. Time to put this problem on the front burner!

America used to excel in competence. What happened?

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