Generic drugs are significantly cheaper and, according to the Food and Drug Administration, are bioequivalent to the drugs they are designed after. No surprise therefore that an analysis of 47 articles comparing brand and generic cardiovascular drugs, just published by researchers at Harvard in the Journal of the American Medical Association, showed similar clinical results. The findings were comforting, but as the researchers noted, these were short-term evaluations, and many of the studies were supported by generic drug companies.
But the comparisons raise another uncertainty that was barely a consideration a decade ago: Unlike most patented and many brand-name drugs, the generics are far more likely to be made in factories in parts of the world like India that have cheap labor and overhead. China—which has suffered a string of manufacturing scandals, including one involving contaminated heparin that led to serious and deadly allergic reactions in the United States—is gearing up to become a major producer of generic drugs and is expected to compete with the likes of India at even lower prices.
At what point do we ask whether we are chasing price faster than is good for us? Maybe now. According to a scathing report issued by the Government Accountability Office in September, foreign countries escape rigorous FDA inspection, documentation of their practices, and follow-up monitoring even when serious manufacturing or drug-handling problems have been identified. Worse, the GAO has identified these problems with FDA oversight in the past, and they have gone largely uncorrected—at the same time that outsourcing of generic drugs to Asia has been skyrocketing.
What has gotten surprisingly little attention is that on the heels of the GAO report, the FDA halted imports from two plants of Ranbaxy Laboratories, a major generic drug producer in India. The action closed our borders to over 30 generic drugs because of manufacturing deficiencies that put the products at risk for contamination and other safety problems. The banned list looks like a roster of drugs sold in your local pharmacy, including commonly prescribed antibiotics, diabetes medicine, and a cholesterol-lowering statin.
The FDA kept one antiviral agent important to AIDS patients off the banned list since that would have meant a U.S. drug shortage. A shortage, in a country that is spending $2 trillion a year on healthcare? This gets more worrisome. As China, India, and other countries with cheap labor compete to take up more of U.S. drug manufacturing, will quality and regulatory standards, which make domestic production of lifesaving drugs more costly, be held hostage by a foreign company that controls so much of the market it can tell our government to take a hike?
One would hope this will change. The FDA import ban is a sign that the agency is taking the foreign inspection failures seriously. And the FDA is now opening offices in China to beef up its presence there. But the agency is strapped for resources—people and money—and remedies will take a while.
One way to speed up the process and assure better quality is to get patients involved: We should insist that the government make regular spot checks of the ingredients of imported drugs readily available to the public and arrange for independent analyses comparing generics to brands. And how about requiring that those "made-in-whatever-country" labels attached to clothing be printed on every medicine bottle?