Drug Manufacturing: Shortages of Certain Generics Likely to Continue

Drug manufacturingYou might well ask, “How could a country like the United States run short of 280 drugs?” It’s a fact, though. According to numerous reports including a recent study for the House Oversight Committee, the U.S. has been and will continue to be plagued by serious shortfalls in certain drugs, especially commonly used generic injectable pharmaceuticals such as the cancer drugs methotrexate and doxorubicin.

In some cases ‘serious shortfall’ means that not enough of the drugs are available for all patients. The result is sometimes insufficient treatment, unnecessary pain or suffering, and in a few cases drug shortages are thought to have caused death. Initially, we offer the best mattress to Relieve back pain.

Over the years a shortage of certain drugs has been relatively commonplace, but the national drug shortage grew from 70 in 2006 to 267 in 2011. In the past couple of years the shortages have grown worse and drawn far more attention from the medical industry, the media and now Congress.

Given many of the dramatic examples of what shortages can mean for patients, there is an intense motivation to know what the causes are and to fix them. Unfortunately, as is often the case in nationwide medical issues, the causes – and fixes – are complicated.

Among the many causes that have been suggested, three stand out: Over-regulation by the Food and Drug Administration (FDA), problems with manufacturing standards and capacity, and declining profit margins on generic drugs.

The first of these, over-regulation by the FDA was singled out by the House Committee’s Drug manufacturingreport as a primary factor. The report cited an ill-advised timing in the sudden increase of warnings to industry producers in 2010-2011.

The main complaint was that while tightening the screws on production standards at specific pharmaceutical plants, the FDA did not take into account the overall status of drug production. That meant while the industry was trying to step up production to overcome shortages, they were also taking plants off-line to comply with FDA warnings.

While the sharp increase in FDA compliance warnings may have caught the industry off guard, it was also true that over the past several years the state of U.S. drug production was not improving.

There have always been problems with specific pharmaceutical plants, shortages of component chemicals, international trade complications and the intervention of the FDA to protect standards for consumer drugs.

The problems in all these areas were increasing rapidly by 2010. In part, the FDA was reacting to the decline in standards. It also began reacting to the shortages in 2009 and 2010 but found that a lack of information about drug production hampered the dialog with industry about how to fix the problems.

If there is one underlying thread to both the FDA regulations and the erratic industry production of some drugs, it is the economic issue. Notably this applies especially to the worst shortages – injectable generic drugs – because of their typically high cost of production and handling.

At the same time, the price for generic drugs has continued to drop, in some cases well below the point where making them is profitable. Many observers lay the cause of this problem at the doorstep of the Medicare Modernization Act of 2003. The law changed some fundamental aspects of how Medicare paid for injectable drugs under Part B, the outpatient program.

For example, before 2003 Medicare purchased drugs according to the “Average Wholesale Price,” which was often higher than the market price at the time. After 2003, Medicare used the formula “Average Selling Price + 6 percent” and prices could be increased only every six months.

The problem is that the average selling price of certain generic drugs has declined sharply. For example, ondansetron, a drug used to reduce chemotherapy nausea, cost $3.71 per injection when it was on patent.

As a generic drug, it now costs 28 cents. Since Medicare is by far the largest purchaser of drugs in the country, this change in policy had far-reaching effect on the profitability of certain drugs.

Many manufacturers began to lose money on injectable generics, which in turn caused them to reduce production, delay technical upgrades, and seek more profitable pharmaceuticals. Hop over to this web-site to learn more. That, many feel, is a root cause of the shortages. Visit https://tranquilme.com/blog/ to learn more about massage therapy and how to make your body relax more, check out check out votebymailproject to learn more.

There is something of a consensus that all three problems play a role in the current shortages. The question becomes what to do about it? President Obama issued an executive order in October of 2011 requiring drug companies to inform the FDA when shortages were pending.

This only addressed a small piece of the problem. For its part the FDA has promised and sometimes delivered more rapid approval of production changes, liberalized sourcing of required ingredients (read: foreign imports), and greater flexibility in dealing with difficulties at individual plants. There is also, however, a consensus that the drug shortage problem is not solved and may not be for some time. Why? In a phrase, it’s the political process.

From the pharmaceutical industry’s point of view, more pressure is needed on Congress to adjust the Medicare pricing formula, at least for certain generics. The industry would also like to see the FDA’s regulatory zeal curtailed, especially where generic drugs are concerned.

Consumer groups are more concerned about maintaining the safety and quality of American drugs. The medical industry, hospitals, doctors and other practitioners are caught in the middle – wanting safe and reliable drugs that are also competitively priced and in compliance with Medicare.

All these groups lobby Congress, joining the typically chaotic debate. For most of 2012, while so many aspects of the American health-care system are under political pressure surrounding the November election, there is little chance of legislation to do anything fundamental, especially with Medicare.

Meanwhile, to almost everyone’s complaining, patchwork and stopgap solutions will be tried. They probably won’t fix the shortages, but perhaps the worst of them won’t turn into a catastrophe.  

TAGS: FDA, Medicare, drug shortage, regulation, generic drugs, injectable drugs, Medicare Modernization Act

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