Drug shortages vex the U.S. despite the FDA's best efforts

The number of new drug shortages in the U.S. has fallen dramatically during the last few years. This comes after the FDA laid out a new strategy, and was helped by a presidential order that drugmakers must speak up if they foresee anything that even looks like it could turn into a shortage. Still, the total number of shortages keeps growing, leaving doctors to figure out how to change treatment plans when meds are unavailable.

According to a report on shortages from the FDA, the agency was able to ward off 140 potential drug shortages during the first 9 months of last year. The agency said there were only 38 new shortages reported in that period, a huge decline from 2012 when there were 117 new shortages during the full year. On average, the 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 they are having production issues--or foresee 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.

But as a Government Accountability Office (GAO) report last week pointed out, while the growth has slowed, the total number of drug shortages has gotten larger every year since 2007. It reached 288 through June of last year. There were 456 active shortages during 2012, made up of 195 new shortages and 261 shortages that began before 2012 but remained ongoing at least some period of time in 2012, the GAO said. Further, the report says that 240 drugs have turned up on the shortage list multiple times between Jan. 1, 2007, and June 30, 2013, representing 622 individual shortages.

Sometimes the shortages involve essential drugs, like Johnson & Johnson's ($JNJ) ovarian cancer drug Doxil, which appeared on the list in 2011 when its contract manufacturer Boehringer Ingelheim had to stop production because the FDA found a boatload of problems at its plant in Ohio. The FDA's response to that shortage illustrates the variety of ways it has been trying to resolve shortages. 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.

Those problems illustrate one of the conundrums in the pharma supply chain, as many of the generic sterile injectable drugs are low-margin products made at old plants that are more prone to quality issues. Sometimes drugmakers, like Boehringer Ingelheim, decide there is not enough profit in them to plow money into plant upgrades needed to keep producing. The German drugmaker said as much last year when it decided to close its Ben Venue plant in Ohio that was at the center of the shortage of Doxil and other drugs.

More recently, the FDA has been battling a shortage of a more mundane product--saline solution--but one which hospitals turn to millions of times a week. The FDA is working with three saline manufacturers in an effort to boost production. Two of the producers had to recall saline last year because of particulate found in some of the products.

- here's the FDA report (PDF)
- and the GAO report (PDF)

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