Recent shortages of cancer medicines have brought to light an often problematic disconnect between the financial incentives of drug manufacturers and the needs of patients. Dr. Robert Mayer of the Dana-Farber Cancer Institute in Boston explained to Reuters the importance of these drugs, “which serve as the backbone for treating many of the most common and treatable cancers.” However, many of these drugs are now in short supply because of their slim profit margins for generic drug companies, as well as quality control issues among manufacturers. Unfortunately, oncologists see little likelihood of the situation righting itself any time soon.
“This is the flip side of the generic drug paradigm,” says ACSH’s Dr. Josh Bloom. “Not long ago, people were raving about the holy grail of generic drugs and how they would solve our health care crisis by cutting medical costs. Well, they may have (barely) cut costs, but you get what you pay for — old drugs instead of new ones, and appalling supply problems. This is the United States, not Cuba. I am mortified by this.” Dr. Bloom wonders if one solution might lie in an extension of patent life — which would then re-establish a company’s financial incentive to manufacture a given drug. “However, given today’s political climate, this is very unlikely,” he says. Meanwhile, ACSH's Dr. Gilbert Ross notes, there remains this horrible conundrum: Oncologists with a limited supply of a necessary drug must determine how to mete it out among their patients. “And while it’s true that extending patent life might well increase supply,” he observes, “the cost would also rise.”
ACSH’s Susan Z. Ingber believes such cost increases can be at least partially ameliorated by an overhaul of the onerous FDA drug evaluation process, allowing drug makers to reduce the huge costs of drug development.
So far, the only government response to these shortages has been a February 2011 bill introduced by U.S. Senators Amy Klobuchar (D-MN) and Robert Casey (D-PA), which would require drug companies to inform the FDA about supply problems or intentions to cease drug production, theoretically allowing the FDA time to arrange for other suppliers to manufacture the drugs or to call for imports.
Dr. Bloom acknowledges that “some regulatory flexibility by the FDA might help; but in reality, the more we rely on imported drugs and unreliable generic companies, the more this kind of shortage will be seen in the future.”