U.S. Makes Progress on Drug Shortages

Reuters

May 4, 2012

Health officials said the number of new shortages of crucial drugs used to treat cancer and other illnesses had been halved compared with a year ago, and attributed the improvement to earlier notice from drugmakers about looming supply issues.

There have been 42 newly scarce drugs so far this year compared with 90 in the same period a year ago, U.S. Food and Drug Administration Commissioner Margaret Hamburg said Thursday on the agency’s website.

Efforts to combat shortages escalated last year, when 250 medicines were in short supply, up from 56 in 2006. Some doctors have been forced to postpone care, use second-best drugs or turn to more costly alternatives to compensate for shortages.

According to an FDA list, which is updated daily, there are currently about 120 drugs regarded as being in short supply. President Barack Obama made shortages a national priority with an executive order last October, and the FDA sent letters to companies asking for voluntary notification about supply disruptions.

Early notice has helped the FDA prevent 128 shortages since then, mainly by asking other companies to boost production to make up for a competitors’ shortfall. In some cases, the FDA has also approved temporary imports of drugs from abroad or sped up new drug applications.

“Six months later, I am both amazed and delighted to see the progress that’s been made,” Hamburg said. Although she said shortages of drugs such as leucovorin, used in the treatment of childhood leukemia, or fentanyl, used in anesthesia, are still affecting patients, and the FDA is working with companies to resolve the issue.

U.S. lawmakers have proposed legislation that would force companies to report all shortages or temporary supply disruptions, rather than relying on their voluntary action. Under current law, companies must only report that they will stop making a drug if they are the only manufacturer of a critical or life-saving medication. The legislation is expected to be part of an FDA “user fee” funding bill that is set to be voted on by Congress in the next few months.

FDA officials say several industry factors have created the shortages, including a consolidation of generic drugmakers, manufacturing problems that have shut down multiple plants or production lines and the decision by some manufacturers to stop producing a treatment when profit margins erode too far.

Generic drugmakers such as Hospira Inc and Teva Pharmaceutical Industries say they are building new facilities as a backup for future shortages, but it may take a year or more for the impact to be felt on current production.