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America’s Pill Paucity

America’s Pill Paucity


There’s a drugs shortage in America. That the construction of such a sentence is possible seems baffling for a nation that has led the world in medical innovation for decades.
Last Updated: 07-Sep-2011

There’s a drugs shortage in America. That the construction of such a sentence is possible seems baffling for a nation that has led the world in medical innovation for decades. As I first documented back in March, America is oft cited as the global leader in drug innovation. Measured by the metric of Nobel Prizes, a 2010 CATO Institute study showed that over 60% of the recipients of the Nobel Prize for Medicine between 1969-2008 hailed from the United States. Similarly, of the six most groundbreaking medical discoveries of the past 25 years, four find their roots on American soil.

Given this stellar pedigree in medical research, it is then astonishing to find that so far this year, more than 198 drugs have been declared in short supply by the Food and Drugs Administration (FDA). Over 180 of these drugs, the New York Times reports, are essential in the treatment of illnesses such as leukaemia and breast cancer. And while that number is technically lower than the 211 drugs declared in short supply by the FDA in 2010, the evidence is decisive and the crisis is real. Specifically, while shortages are arriving in a variety of forms, the majority of the drugs affected are generic and most administered by way of injection. One example, cited by the Economist, concerns hospitals desperate to acquire the electrolytes needed to keep premature babies alive.

In determining the roots of the crisis, America’s politicians — and indeed the FDA itself — find several causes. In the first instance, more than half of the recent shortages are due to the detection of microbial contamination within medicines borne out of foreign factories. Heather Bresch, president of Mylan, a generic drug giant operating out of Canonsburg Pennsylvania, told the Times that “If the F.D.A. was required to inspect foreign drug plants at the same rate it does domestic ones, we might not have so many of these shortages”. Undoubtedly then, some of the blame lays with the regulators.

Another cause can be found in an almost unavoidably ugly characteristic of capitalism. Put simply, with generic drugs often commanding unattractively low prices in the market place, many manufacturers simply drop certain drugs from their roster because they don’t draw adequate revenues. In the next instance, third party vendors then purchase the remaining stockpiles of the drug and hoard them on-mass. Subsequently selling them for three to four times their original worth. Thus, these are the problems. But what of the solutions? On the inspection side, Mrs. Bresch has already brokered an agreement that would require the industry to contribute towards the cost of foreign plant inspections. The deal is yet to be approved by Congress, but would, if passed, force American drugs companies to contribute $299 million a year towards the cost of inspecting foreign facilities.

On the regulation side itself, a bill currently passing through Congress, and sponsored by Senator Amy Klobuchar (D-Minn), stipulates that drug companies must provide the FDA with at least 6 months warning prior to the discontinuation of a product. Michael Link, President of the American Society of Clinical Oncology, says that such a rule might have the unintended effect of inspiring wholesalers to build even greater stockpiles of the medicine - thus hampering middle-class patients even further. Conversely, Klobuchar bases her support for the bill on the fact that the FDA has already prevented 38 shortages after receiving early warnings from drug makers. At the Executive level, President Obama is also considering the idea of building federal government stockpiles of the most crucial of cancer medicines. But all such ideas remain purely embryonic in their form.

One thing is for certain, such shortages cost lives. And to compound the problem even further, the FDA’s Drug Shortage Program currently relies on a total of four employees to manage the shortage crisis on a day-to-day basis. Yet asking a Republican-controlled House of Representatives for additional resources in the current climate seems akin to asking a turkey if it’s in favour of Christmas. While the answer will always be an unassailable no, America’s patients deserve better from their politicians.