Drug shortages - caused by bureaucracy?

Warren Meyer, writing at Coyote Blog, highlights the accumulation of regulations governing the pharmaceutical industry. He links, via a couple of intermediate Web sites, to this post by John Goodman on the Health Affairs blog.

Doctors at the Johns Hopkins cancer center are rationing cytarabine, a drug used to treat leukemia and lymphoma. They are literally deciding who will live and who will die. The drug is also in short supply at the Stanford, Wisconsin and Nebraska university medical centers. Large medical centers, in Oklahoma and Maryland have completely run out.

All of this might be dismissed as an unfortunate turn of events were it not for the fact that a lot of other drugs are also in short supply. About 90 percent of all the anesthesiologists in the country report they are experiencing a shortage of at least one anesthetic, for example. Drug shortages are also endangering cancer patients, heart attack victims, accident survivors and a host of other ill people. The vast majority involve injectable medications used mostly by medical centers, in emergency rooms, ICUs and cancer wards.

Currently, there are about 246 drugs that are in short supply and as the chart shows, the number has been growing for some time. There were 74 newly reported drug shortages in 2005; the number dipped slightly to 70 in 2006, then rose to 129 in 2007, 149 in 2008, 166 in 2009, and 211 in 2010.

As early as 2005, hospitals and clinics complained to Health and Human Services Secretary Michael Leavitt that drug manufacturers and distributors were often out of certain drugs. The problem has been getting progressively worse ever since. A new report from the Premier healthcare alliance that found that drug shortages have risen to “critical levels,” endangering the public’s health. Hospitals are scrambling to make up the shortfall, in some cases rationing medications, postponing surgeries and using alternative drugs.

So what’s going on?

Industry insiders point to numerous causes of the problem, including the fact that the generic drug market may be inherently more volatile than the market for brand-name drugs. Others point to supply chain problems. Then there is government regulatory policy.

Output Controls. The Federal Food and Drug Administration (FDA) has been stepping up its quality enforcement efforts — levying fines and forcing manufacturers to retool their facilities both here and abroad. Not only has this more rigorous regulatory oversight slowed down production, the FDA’s “zero tolerance” regime is forcing manufacturers to abide by rules that are rigid, inflexible and unforgiving. For example, a drug manufacturer must get approval for how much of a drug it plans to produce, as well as the timeframe. If a shortage develops (because, say, the FDA shuts down a competitor’s plant), a drug manufacturer cannot increase its output of that drug without another round of approvals. Nor can it alter its timetable production (producing a shortage drug earlier than planned) without FDA approval.

Even the Drug Enforcement Agency (DEA) has a role — because minute quantities of controlled substances are often used to make other drugs. This is the apparent reason for a nationwide shortage of ADHD drugs, for example, including the generic version of Ritalin. And like the FDA, DEA regulations are rigid and inflexible. For example, if a shortage develops and the manufacturers have reached their preauthorized production cap, a manufacturer cannot respond by increasing output without going back to the DEA for approval.

There's more at the link. Italic print is my emphasis. The article lists other causes of the problem, such as price controls, stockpiling, black markets, and the cascading effects of drug shortages on other markets. It's worth reading in full. The shortages John Goodman reports are confirmed by other sources.

For the life of me, I can't see why some government bureaucrat should wield decision-making authority over a manufacturer's volume of production! If they want to produce more of a drug - why not? What possible reason can any government department have for interfering in such a decision? As long as the drug(s) meet required standards for efficacy, purity, etc., why should any government department have any say in the matter? It's not as if we're talking about heroin or LSD - we're dealing with legitimate medical drugs!

This just boggles my mind . . .

Bureaucrats! Grrr!





Peter