The Shortage of Vital Drugs

A widespread shortage of prescription drugs is hampering the treatment of patients who have cancer, severe infections and other serious illnesses. While some Republican politicians have railed against the imaginary threat of rationing under health care reform, Congress has done nothing to alleviate the all-too-real rationing of lifesaving drugs caused by this crisis.

The Food and Drug Administration says that some 180 medically important drugs have been in short supply, many of which are older, cheaper generic drugs administered by injection that have to be kept sterile from contamination.
A survey of 820 hospitals in June by the American Hospital Association found that almost all of them had experienced a shortage of at least one drug in the previous six months and that nearly half had experienced shortages of 21 or more drugs. As a result, more than 80 percent of the hospitals delayed needed treatments, almost 70 percent gave patients a less effective drug, and almost 80 percent rationed or restricted access to drugs.
Although there is limited data on how many patients have been harmed, a survey of 1,800 health care practitioners last year by the Institute for Safe Medication Practices found that a third of the physicians and a fifth of the pharmacists knew of adverse patient outcomes because of shortages, including some deaths from microbes resistant to the backup drugs. Cancer patients receiving less effective drugs may well face increased risks in the future.

Nobody is sure just what is causing the shortages because drug manufacturers are not required to report any reasons to the F.D.A. But several factors are likely to be involved: contamination problems at some manufacturing plants, forcing unexpected production shutdowns; difficulties in getting pharmaceutical ingredients from suppliers, especially those abroad; reluctance to invest in production-line improvement for low-profit generics when high-priced brand-name drugs bring in far higher profits. Sweeping consolidation in the generic drug industry means that fewer companies are left in that market to make up for a shortage.
The shortages are forcing health care providers to buy more expensive products in the absence of cheap generics. Unscrupulous wholesalers have made matters worse by scooping up scarce drugs and offering them to hospitals at markups that often reach 20 times the normal price or more, according to a recent survey.
Beyond limited responses, like using the F.D.A.’s discretionary powers to expedite temporary imports of drugs that are sold overseas but not here, there are very few ways to ease the crisis. For the longer term, bipartisan bills in Congress would require drug makers to give the F.D.A. six months’ warning of problems that might disrupt supplies. For that to work, the penalties for noncompliance would need to be stiff.
Other proposals include a national stockpile of critically important drugs, incentives to encourage the manufacture of generic drugs, and broader powers and additional resources for the F.D.A. to head off looming shortages. Some, perhaps many, Congressional Republicans will inevitably oppose an expansion of the F.D.A.’s regulatory authority. This cannot and must not be a fight over ideology. For many Americans, it is a fight for their lives.