Making Bad Drugs? Three Strikes and You're Out

December 13, 2012

Hundreds of Americans were harmed by the recent outbreak of meningitis caused by tainted steroid injections. Sadly, this case represents a broader trend in counterfeit or substandard pharmaceutical drugs. Authorities have begun to step up and halt the spread of these pharmaceutical drugs to some success. For example, about 82 million doses of counterfeit drugs were seized in Africa. The problem is that such crackdowns tend to focus on counterfeit drugs, deliberately falsified by criminal networks, says Roger Bate of the American Enterprise Institute.

A much bigger public health problem is substandard drugs that are the result of shoddy manufacturing and handling -- or perhaps worse, deliberate corner-cutting.

  • In poorer countries, bad drugs reach patients through supply chains or donor programs that may be underwritten by the United States or Europe.
  • Many drugs made by Chinese and Indian manufacturers tend to be substandard but offered at lower costs.
  • These bad drugs may not be completely counterfeit, but rather be substandard with doses of active pharmaceutical ingredients.
  • Because of this, it is more difficult to catch before there is an increase in resistance to an entire class of drugs.

Many donor governments and agencies that distribute pharmaceutical drugs take measures to ensure the quality of medicine. Some governments and donors will only purchase medicines to distribute that have already been approved by strict regulatory agencies like the U.S. Food and Drug Administration, the World Health Organization (WHO), or a European equivalent.

But many times these agencies fail to catch low-quality pharmaceutical drugs. For example, one study collected more than 15 percent of Chinese drugs that were approved by the WHO but did not have adequate amounts of active pharmaceutical ingredient.

One shining example of how donor groups and other governmental or non-governmental organizations should model themselves after is the U.S. President's Malaria Initiative (PMI). The program subjects every batch of every drug to analytical quality testing before being shipped. Donor agencies should look at a few other options to try and reduce the prevalence of counterfeit or substandard drugs.  First, any manufacturer found with failing batches of drugs on more than three occasions in a year are not eligible for tendering the next year.

Second, the United States should take it upon itself to make pre-shipment batch testing and post-market surveillance a condition for all drug-related aid. Since the United States is a major contributor to health-related aid, like the Global Fund, it has a lot of influence in sending a message about its commitment to halting the spread of substandard drugs.

Source: Roger Bate, "Making Bad Drugs? Three Strikes and You're Out," The Hill, December 7, 2012.


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