Making bad drugs? Three strikes and you’re out

{mosads}The problem is that such crackdowns tend to focus on counterfeit drugs, deliberately falsified by criminal networks. A much bigger public health problem, as the tainted steroid injections demonstrated, is substandard drugs that are the result of shoddy manufacturing and handling – or perhaps worse, deliberate corner-cutting.
In poor countries, a frightfully high number of bad drugs reach patients through legitimate supply chains and even donor programs underwritten by U.S. and European taxpayers. Substandard drugs tend to have a suboptimal – but non-zero – dose of active pharmaceutical ingredient. This can be worse than deliberately counterfeited drugs containing no active ingredient because the substandard products are more likely to rapidly increase population-level resistance to an entire class of drugs, in addition to harming the individual patient.
Donor governments and UN agencies do take measures to ensure the quality of medicine. Most governments or multilateral donors, for example, will only purchase for aid programs medicines that have been approved by a stringent regulatory authority – such as the U.S. Food and Drug Administration or its European equivalent – or by the World Health Organization (WHO). But this isn’t enough to safeguard patients against poor quality drugs.

As I’ve demonstrated through previous research, off-the-shelf drugs made by Chinese and, to a lesser extent, Indian manufacturers tend to perform inconsistently on quality tests. In one study, more than 15 percent of the Chinese drugs we collected that were approved by the WHO failed to include adequate amounts of active pharmaceutical ingredient.
Worse still, some of the drugs we tested had been bought through Western donor programs, funded by taxpayers, and steered through aid programs to African markets. Some of these drugs may have degraded through bad storage, but many were just badly manufactured, perhaps to cut corners to lower costs and increase profits. After all, once a manufacturer has obtained quality certification, it is relatively easy to sell the drug at a lower quality in countries with weak regulations.

My research team’s latest paper, published this week in Malaria World Journal, reinforces these findings. Less than three percent of manufacturers approved by the WHO had insufficient active pharmaceutical ingredient. Among manufacturers not approved by the WHO, the percentage of failures shot up over 12 percent.

Digging deeper into donors’ regulatory practices, we discovered that the U.S. President’s Malaria Initiative (PMI) is the only donor program that effectively self-polices when it comes to drug quality. According to PMI, it “subjects every batch of every drug…procured with malaria funds to various analytical quality testing…” As a result it finds occasional poor quality products and has occasionally returned products with quality issues to the manufacturer based on this testing.
That’s a sharp contrast with other governments and multilateral donors like the Global Fund to Fight AIDS, TB and Malaria, which outsources the job of assuring drug quality throughout the supply chain to the principal recipients of its grants. This is usually a government agency in the target country. This simply doesn’t do enough to ensure that only good quality medicines are being procured and distributed with Global Fund resources. It is unclear, for example, how often quality control testing is actually being performed by donors.
If we’re going to make progress, donors need to copy the PMI and conduct pre-shipment testing of every batch of drugs provided to poor countries. If the U.S. Government’s flagship malaria program insists on such quality control measures, should not all donor agencies receiving taxpayer dollars do likewise? We suggest implementing the following policy: Any manufacturer found with failing batches of drugs on more than three occasions in a year, will not be eligible for tendering in the following year.
The U.S. should also make pre-shipment batch testing and post-market surveillance a condition of all drug-related aid, especially for the Global Fund. While the 2013 budget for PMI is the same as in previous years, the Global Fund will see its budget increase, whereas on performance the reverse should be the case. Because the U.S. is the leading donor to the Global Fund by far, demanding better drug surveillance would send a clear message both to the organization’s new management and to other donor governments: it is time to take the global fight against substandard medicines seriously.
Bate is a resident scholar at the American Enterprise Institute.

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