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How safe are your prescription drugs?

By Aaron Carroll
updated 8:37 AM EST, Tue February 25, 2014
Customs in Brussels, Belgium, seized more than 2 million counterfeit pills made in India and bound for Africa in 2008.
Customs in Brussels, Belgium, seized more than 2 million counterfeit pills made in India and bound for Africa in 2008.
STORY HIGHLIGHTS
  • Aaron Carroll: Americans worry about safety of buying cheaper drugs in Canada
  • Carroll: We import 40% of our drugs from India; contamination and fake pills are a problem
  • He says India allowed inspections; China, which also makes drugs, resists them
  • Carroll: We need to support the government in its efforts to protect us overseas

Editor's note: Aaron E. Carroll is a professor of pediatrics at the Indiana University School of Medicine and the director of its Center for Health Policy and Professionalism Research. He blogs about health policy at The Incidental Economist and tweets at @aaronecarroll.

(CNN) -- Every once in a while, people get all crazy about the idea that some people might "import" drugs from Canada. Many pharmaceuticals are much cheaper in that country and many Americans, especially those who live on the border, are sometimes tempted to buy their drugs there.

Inevitably, when this topic comes up for debate, someone questions the safety of those drugs. This concern is somewhat overblown. Canada isn't a banana republic, and it does a rather good job of ensuring the safety of its citizens without our help.

Aaron Carroll
Aaron Carroll

Moreover, it's a concern that ignores that the vast, vast majority of drugs we buy here are not manufactured here. We import most of what we consume.

For some reason, we don't seem to be as concerned about the safety of our drugs here are home. It turns out, though, that we might need to rethink that, according to a recent story in The New York Times.

For some time, many people, including me, have been advocating for greater use of generic and over-the-counter drugs over bioequivalent name brand drugs because they would result in significantly decreased health care spending. Those arguments have resonated with the American people, and generic drug use has increased dramatically. In response, countries have massively increased their capacity to produce such drugs.

For instance, about 40% of all over-the-counter and generic drugs used in the United States are produced in India. In response to this and other factors, the Food and Drug Administration Safety and Innovation Act was passed in July of 2012. Part of the law involved changes to generic drug user fees. Companies looking for approval now need to pay some extra money to allow for better inspection of production facilities.

And in India, those inspections are bearing fruit.

This is leading many pharmaceutical companies to question whether India is a safe ... place to manufacture their drugs. India's drug industry is in a panic.
Aaron Carroll

Last year, inspectors from the FDA looked at 160 drug plants there. What they found was often quite concerning. Drugs were sometimes adulterated or contaminated. Facilities were often filthy or infested with bugs. They also caught some executives lying to them, leading to felony charges.

As you can imagine, this is leading many pharmaceutical companies to question whether India is a safe and reasonable place to manufacture their drugs. India's drug industry is in a panic.

They should be. The World Health Organization has, for years, monitored the use of falsified or counterfeit medicines, and some of the problems have been in the United States. The New York Times documents many instances in many countries where improperly made or counterfeit drugs led to serious consequences, including deaths.

Many people have legitimate concerns about how much regulation goes into the approval of drugs in the United States. Some believe the FDA is too cautious and makes it too difficult for people to get the medicines they want or need. But examples like this are a cautionary tale about how some regulation is necessary.

Without proper oversight, people in the United States, not some Third World nation, are at risk for buying counterfeit drugs in their pharmacies. They are at risk not only for not getting the benefit they expect but also a negative consequence they didn't see coming.

In many ways, you get what you pay for. Companies have been using India for production largely because they have been able to do it so cheaply. But it's becoming apparent that one of the reasons for those low costs may be because they were doing a much less-than-perfect job. Fixing the problem will likely mean that they will lose their competitive advantage.

If pharmaceutical companies move out of India, they will likely decide to go to other countries that can also offer cheap services. One of those is likely China. But China, unlike India, has blocked U.S. efforts to send FDA inspectors. We're in a similar situation to what we had in India before the increased oversight.

This is far from over. We need to be vigilant. We also need to support the government in its efforts to protect us overseas. Fixing this problem, both now and in the future, will require resources and a firm stance. It may also require us to pay more for our drugs than we have in the past.

That won't be popular, but sometimes good things cost money.

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The opinions expressed in this commentary are solely those of Aaron Carroll.

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