Drug shortages remain a significant health problem in the U.S. and the main cause can still be traced to drugmakers halting production to fix a quality problem. Two reports released last week show that steps by the FDA during the last few years to get on top of the issue have in fact gone a long way to slowing the number of new shortages. Still, that total keeps increasing.
The FDA, reporting for the first 9 months of 2013, said that the agency helped prevent 140 potential drug shortages. And there were only 38 new shortages reported in that timeframe. That compares with 117 new shortages in all of 2012. On average, that 38 tallies up to less than half the number reported in 9 months of 2012.
The agency ties that trend back to the requirement that drugmakers must now let it know when it is having an issues, or foresees an issue, that would affect drug availability. Those notifications allow the agency to respond, and sometimes take actions to fill the gap, like work with other drugmakers to expand production or speed approval of a drug from another supplier.
When manufacturing problems cropped up at an old Boehringer Ingelheim plant, it created a shortage of the ovarian cancer drug Doxil that it manufactured for Johnson & Johnson ($JNJ). The FDA moved in several different directions. It allowed an unapproved version of a similar drug from Sun Pharma into the country on an interim basis and then worked with Sun to win approval of its drug for the U.S. The agency is currently working with J&J in its effort to set up its own manufacturing at the now closed Boehringer plant because J&J has so far been unable to get another contract manufacturer ready to make it.
That said, a report by the Government Accountability Office (GAO) last week pointed out that while there are fewer shortages popping up, the the total has gotten larger every year since 2007. It reached 288 through June of last year, up from 261 in 2012. According the GAO report, the shortages most often are of generic versions of sterile injectable drugs. That has been because of problems at old plants that cause quality issues. According to The New York Times, a written testimony Monday from the FDA's Dr. Douglas Throckmorton said that 66% of the production disruptions that led to shortages were caused by quality problems and efforts to fix them.
And that, the GAO said, means issues for patients. "Provider association representatives reported that drug shortages may force providers to ration care or rely on less effective drugs," the GAO said.