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Do You Know Who Is Making Your Medicine?

Tuesday, December 11th, 2012

Here’s an update on the story about the contaminated steroid injections that caused an outbreak of meningitis. Investigations into the incident have revealed dangerous practices in a largely unregulated part of the pharmaceutical industry. Our medicines may not be as safe as we’d like to think they are.

Earlier this year, hundreds of people in several states developed meningitis after receiving steroid injections to relieve back pain. Nationwide, as many as 36 people have died from the injections. The contaminated steroid medication was traced to a Massachusetts pharmaceutical lab that knowingly was mixing “sterile” medicine in rooms contaminated with mold and bacteria.

The incident shed light on a little-known, and little-regulated, part of the pharmaceutical industry called “compounding pharmacies.” Originally, compounding pharmacies were “special order” suppliers that compounded medicines customized for individual patients. However, over the years — and out of sight of the Food and Drug Administration — many of these medicine suppliers turned into unregulated drug factories. Instead of limiting themselves to individual orders, they are making drugs in bulk that could be given to anyone in the U.S., including you.

Why don’t compounding pharmacies receive the same FDA oversight as other parts of the pharmaceutical industry? The short answer is that the pharmacies are protected by a smart and aggressive trade organization that knows its way around Washington.

Back in 1997, Congress did pass a law that gave the FDA more regulatory authority over the compounding pharmacies. But a group of pharmacies filed a suit against the law, and the Supreme Court overturned it in 2002. This was after four people had died in a 2001 meningitis outbreak from contaminated steroid shots.

The following year, an FDA official testified to a Senate committee that the agency had surveyed medicines from 12 compounding pharmacies, and ten of the 29 sampled drugs failed quality tests.

In the years since, Congress has considered proposals to regulate compounding pharmacies, but lobbyists for the International Academy of Compounding Pharmacists (IACP) obtained the support of key legislators to kill each attempt. In doing so, the IACP followed the path made by other industrial groups — coal mine owners, for example — claiming that regulation would create too many financial burdens and put the industry in jeopardy. So, peoples’ lives are put in jeopardy.

This pattern repeats itself over and over in the U.S. Industries are allowed to sell unsafe products or operate under unsafe conditions for employees, and regulatory agencies are not given the resources or the authority to do anything about it.

Some hazards eventually are regulated, but only after many years. For example, asbestos manufacturers stayed in business for years after it was well known that asbestos exposure causes mesothelioma. Eventually most asbestos mining and manufacturing were eliminated in the U.S., but not all. Many consumer products still contain small amounts of asbestos.

Compounding pharmacies remain mostly out of reach of the FDA.  They are regulated by states, but the effectiveness of state oversight varies. In the case of the Massachusetts pharmacy responsible for this year’s meningitis outbreak, the Massachusetts Department of Public Health says the company had shipped its product before testing was complete. Whether the pharmacy routinely skipped safety tests is not clear.