A problem that can be ignored no longer
May 15, 2014 — I found your article entitled “Ignoring a solution to chronic drug shortages” in the May 7, 2014 issue of Remapping Debate to be very provocative. I am currently the Chair of the American Society of Clinical Oncology (ASCO) Government Relations Committee. As you know ASCO was very involved in bringing the problem of drug shortages to the attention of the public as well as the Congress when this problem reached crisis proportions in 2011 (see article published in “New England Journal of Medicine” in 2012). Congress eventually passed the FDA Safety and Innovation Act of 2012 (FDASIA), which was signed into law on July 9, 2012. The FDASIA was structured to ameliorate the problem of drug shortages. While the problem of drug shortages may have improved a bit since the FDASIA was enacted, ongoing shortages have persisted.
I have been amazed and frankly a bit outraged at the apathy that this chronic problem has engendered. It would seem that a thoughtful exploration of the root causes and possible solutions to this problem is needed.
Certainly your proposal for the federal government to manufacture generic drugs would address this issue. As to its impact on generic drug prices, I am a bit unclear, but I can foresee a situation where your proposal would increase drug prices and drive some generic manufacturers out of the market. I do think the federal government could address that issue if it were to arise as well.
Another approach that I have proposed informally to several people would be for the federal government to guarantee to buy and stockpile a “critical reserve inventory of drugs that are in chronic short supply.” The federal government is already in the drug purchasing and distribution business through the VA Hospital System. Medicaid and the 340B Program are also involved in negotiating drug purchasing prices at a lower cost than a retail customer would pay for these drugs. The federal government stockpiles vaccines. We have a critical shortage reserve of petroleum products that the federal government manages. It would seem to be a relatively small step to expand these models to critical drugs in chronic short supply.
A third possibility would seem to be to have the FDA require generic drugs companies to keep a minimum inventory of drugs that have chronically been in short supply on their shelves. Then when there were interruptions in manufacturing due to quality problems, systems breakdowns or problems obtaining raw materials, these inventories would still be available to patients who needed these medications.
There may be other more creative and robust solutions to address this problem, but accepting the status quo seems unacceptable.
Thanks for bringing this issue back in the spotlight for public scrutiny.
— Denis B. Hammond, MD, Bedford, New Hampshire*
*Dr. Hammond submitted this letter in his capacity as an individual physician and not as an official representative of ASCO or any other organization.