At the moment, there is an estimated half-million patients in the United States who are denied access to their prescription drugs due to shortages. This has become a severe and even life-threatening issue in America over the last few months. The number of drug shortages has actually increased approximately 300% since 2005, a dramatic and conspicuous change. The most dangerous aspect of the issue is the type of drugs Americans are struggling to obtain. Over half of the drugs on the shortage list are what are known as critical and many are anesthetics or oncological drugs. This simply means that they have no alternative. In other words, a patient who cannot get a hold of a prescribed critical drug is almost entirely helpless.
In a recent panel, the House Oversight Committee claimed that the FDA is partly at fault for this rising shortage situation. The committee informed the public that the FDA regulatory activity has closed down 30% of the total manufacturing capabilities of four of the largest American generic injectable medication manufacturers. It added that the FDA has been rather careless and ineffective in its managing of the shortage issue. The deputy director of the FDA’s Center for Drug Evaluation and Research, Office of New Drugs, responded to these claims. She said that the FDA has not changed any of its inspection processes and enforcement rules; however, the aging manufacturing infrastructure has been forced to change. This trend of updating and fixing equipment has, according to the deputy director, contributed to this issue. In fact, the FDA’s warning letters increased 156% between 2010 and 2011.
Let’s take the drug Doxil for example. Manufactured by Ben Venue Laboratories, one of the largest four American producers of generic injectables, it was removed from circulation after Ben Venue Laboratories closed down in November 201. They shut down after intensive audits by the FDA resulting in discoveries of metallic particle shards in some of the drugs and miscellaneous issues with a 10-gallon can in a storage area containing urine. Ben Venue Laboratories is currently working to meet regulation. This is only one example of many companies that have shut down that account for 58% of the drugs in the shortage list.
Should the FDA really be to blame for the shortage issue? Are they simply trying to preserve the safety of these drugs? The FDA has made it a mission to not only stop manufacturers that produce hazardous drugs, but to assist them in attaining safe production once more. The issued warning letters ask companies to specifically communicate how they plan to address the problem so that they can better gauge the impact on the shortage as well as guide the company back to regulation standards. The debate continues– who is really at fault for the shortage issue in America?