President Obama ordered the Food and Drug Administration to alleviate drug shortages by broadening reporting of potential shortages, speed review of applications for production, and work with the Justice Department about allegations of price gouging.
There have been 213 drug shortages this year for drugs, some of which are cancer drugs or other lifesaving medications. Hospitals have turned to buying "gray market" drugs, sometimes at exorbitant prices.
Three examples offered by the White House included:
--the typical gray market vendor marks up prices by an averaged 650%.
--a leukemia drug whose typical contract price is about $12 per vial was being sold at $990 per vial, and
--a drug used to treat high blood pressure that was normally priced at $25.90 was being sold at $1,200.
As one example of the dangers of drug shortages and efforts to compensate for them, the Associated Press reported Alabama’s public health department had seen nine deaths and 10 adverse events from bacterial contamination of hand-mixed liquid nutrition given via feeding tubes because the sterile, pre-mixed liquid wasn’t available.
The White House will also send a letter to drug makers reminding them of their responsibility to report the discontinuation of certain drugs to the FDA and to increase staffing resources for the FDA’s Drug Shortages Program to address the increased workload that will result from additional early notification of potential shortages.
The New York Times reported the results of two accompanying analyses of the problem. The analyses note that 74% of the drug shortages involve sterile injectibles. This drug class is expensive and difficult to make, vulnerable to technical challenges and mistakes, and supply hasn't kept up with demand.