Ignoring a solution to chronic drug shortages

Original Reporting | By T.J. Lewan |

Making basic, older generics would not require the government to reinvent the wheel. “Yes, you would have to have good manufacturing practices,” says Morse, the Columbia professor, and although there are some sterile injectables that are harder to make, particularly oncology drugs, “some of these substances are relatively easy to produce and very easily marketed. The demand, in fact, is guaranteed. So, again, if the government is capable of doing this, why shouldn’t it step in to fill a void?”


U.S.A. Generics, Inc.

Ten years ago, drug shortages weren’t the most pressing public-health concern for Allen Vaida, executive vice president of the Institute for Safe Medication Practices, a nonprofit devoted to preventing medication error. But then, in 2008, his organization began finding in hospital surveys that the use of alternative medications for generics in short supply was increasing the duration of diseases and, in far too many cases, leading to the deaths of patients who received improper dosages or who suffered sudden, unexpected reactions from substitutes.

For decades after World War II, public agencies and institutes produced vaccines for biological threats, substances “which are harder to make because you have to do a lot of work on clinical trials as well as safety,” Stephen S. Morse says.

Vaida remembers thinking at the time that the industry would eventually sort things out. Later, as the number of drugs in shortfall doubled, then tripled, then quintupled, he, like many stakeholders, began attending conferences and seminars to seek answers. Invariably, he recalls, discussions continued to center on market-based solutions.

A not-for-profit, government solution simply “wasn’t on anyone’s radar,” he says. Vaida admits he himself “didn’t give it much thought.”

In 2012, Congress reacted to record surges in shortages by granting the Food and Drug Administration expanded powers to manage the problem, a step many observers, including Vaida, viewed as positive.

Indeed, the FDA prevented nearly four times more potential shortages in 2012 than in 2010 — 154 as compared with 38. (The agency recently told Remapping Debate that it had averted 170 potential shortages in 2013.) But Vaida began to look more critically at those numbers: If federal regulators had to act more and more often to prevent shortages, was that a victory? Likewise, if the total number of active and ongoing shortages did not drop below 300 a day — and it hasn’t, in spite of the FDA’s efforts — where was the evidence that the market on its own could make up the shortfalls?

“Unfortunately, we’re at that stage again where we’re saying, yeah, we got together, we came up with a lot of ideas, the FDA got more authority, the FDA increased its staff, the FDA did this and that. But guess what? It’s not working. What are the next steps?”

Once, a market solution seemed to him the only remedy for this problem. But today, he admits, if manufacturers keep showing “there’s no way they’re going to be able to do it, maybe the solution is the government has to do it on its own.”

Vaida’s long journey toward acknowledging the private sector’s shortcomings is far from an anomaly; many experts Remapping Debate interviewed initially rejected the notion that our capitalist economy was unable to deliver reliably all the life-saving medicines we need. When first asked what he thought of the concept, Richard L. Schilsky, chief medical officer for the American Society of Clinical Oncology, didn’t answer directly. “Look,” he said, sighing, “We don’t have a state-run pharmaceutical industry. We don’t have a state-run health care system. We’re a free-market economy.”

Days later, however, he appeared to have given the matter additional thought. “I suppose the government could do what you’re suggesting,” he said. “The government could set up a generic drug manufacturing plant and start churning out these drugs during short supply. They would have to go through the same FDA approval process that any other drug-manufacturing facility would, of course.”

The notion that government is somehow incapable of making generic medications because it hasn’t done so before is myopic, says Aaron Kesselheim. The state, he says, is perfectly capable of quickly assembling people with the know-how for making pharmaceuticals.

For Congress to authorize this, he noted, lawmakers would have to be convinced that drug shortages are as serious a public threat as shortages of vaccines needed to counter pandemics or biological attacks. In Schilsky’s view, the problem is “a substantial public-health issue…You’re talking about kids with curable malignancies whose lives are on the line simply because the substitute drugs aren’t as effective as standard care.” Then, this thought: The government stockpiles serums for pandemics and biological attacks, so “I suppose that’s another kind of precedent that could be invoked” to buttress an argument in favor of a state-run drug factory.

Jennifer Goldsack, a health-services researcher at the Christiana Care Health system in Newark, Del., says that, had she been queried a decade ago about whether the government should step in to stop the shortages, she might not have been very receptive. But now, especially after recently publishing a study that spotlighted the enormous human and financial costs of cancer-drug shortages in this country, she says: “It seems very rational, doesn’t it? I think if there were a simple, market-based solution we would have found it by now.”


Generic drugs aren’t peanut butter

There are, of course, those who continue to believe that the market will satisfy America’s drug needs, harmonizing a profit motive with the public interest.

One such person we spoke to is David Gaugh, senior vice president for Sciences and Regulatory Affairs at the Generic Pharmaceutical Association in Washington, D.C. Though sidestepping a question on whether there’s been a market failure in the generic drug market — “It is a business, like any business” — he did answer candidly when asked to characterize the current state of generic drug shortages in America, saying: “It’s of crisis proportions.”

The crisis is upon us, Gaugh suggested, “because roughly 30 percent of the normally available capacity of these companies [is] offline while they are doing quality compliance remediation work. And when you have 30 percent going off all at the same time, that creates a drug shortage — or can create drug shortages.”

How did these facilities reach such a state of disrepair? Gaugh said “there are a lot of reasons,” but only gave one: that there are only “a limited number of companies that have the technology, the wherewithal, and the capacity to produce these types of products.” If that’s true, why should Americans expect these companies to resolve these shortages anytime soon?

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