Archive 2007 2008 2009 2010

Foreignceuticals: Our Medicines Go Global

You are used to seeing "made in China" (or India, Romania, or wherever) stickers on items you buy. Yet, though there are no labels on medicines, even the most casual reader of the news must know that U.S. pharmaceutical companies are buying increasing amounts of drugs and ingredients for drugs from other countries—billions of dollars worth. It’s estimated that 80% of active ingredients and 40% of all finished drugs are now imported. And the percentages have been rising every year. Of course, the biggest drug companies are still located in North America, Europe, and Japan. But India and China are striving to catch up. They have a big advantage to offer—lower prices.

Your blood pressure medicine or over-the-counter pain reliever, for example, may come from a factory abroad, but you have no way of knowing. The same is true of your multivitamin. Many dietary supplements are imported, though the labels don’t say so. Nearly all of the vitamin C used in supplements (and fortified foods), for example, is made in China—it might as well be called vitamin China. Herbs are harvested all over the world, and there’s no guarantee that the bottles contain what’s stated on the labels, since dietary supplements are very lightly regulated in this country.

If you have a right to know where your socks and TV set were manufactured, and where your fish comes from, surely you have a right to know where your medicines were made. Some federal and state legislators have proposed that imported drugs be labeled as to country of origin.

But how far would that get you? It’s not just knowing the country of origin. What matters is that drugs manufactured in the U.S. are regulated according to strict standards, and manufacturing facilities undergo periodic inspections by the Food and Drug Administration (FDA), a federal agency. Canada and the European Union have their own standards, but this is not generally true elsewhere, not even Japan. Technically, the FDA is supposed to register all exporters to the U.S. and do a pre-approval inspection of any plant supplying drugs to the U.S. But that seldom happens. For one thing, products often go through many hands. The importer may not even know where they came from. In 2006, according to an article in Clinical Pharmacology and Therapeutics, the FDA inspected 212 foreign drug firms, but there are thousands more. It is a job of overwhelming proportions.

What the consequences of this inadequate oversight might mean has been demonstrated in more than one unsettling episode so far. For example, in 2008 an anticoagulant (heparin) sold by an American firm but made in China caused dozens of deaths worldwide, including four in the U.S., plus many allergic reactions. It turned out not to contain the real drug at all, but a cheap substitute. Contaminated cough syrup imported from China killed 56 people in Panama. Just as factories abroad turn out fake designer handbags and phony name-brand wristwatches, they can produce fake drugs. The FDA is currently investigating a number of counterfeit drug cases. Getting adulterated or fake drugs is particularly risky if you buy online.

What you need to know

The drug review system of the FDA was enacted into law in 1938. (The previous year an impure sulfa drug, manufactured in this country, killed 107 people, many of them children.) The agency was empowered to require proof of safety before a drug went on the market, and to enforce safe drug manufacturing practices by means of an inspection system. Since then, the agency was also empowered to require proof of efficacy and has approved more than 3,000 drugs. According to William Hubbard, a former FDA Associate Commissioner and author of a recent article in the Archives of Internal Medicine, this system has become "the worldwide gold standard by which drugs are developed, tested, and approved for use in the general public."

The FDA, to be sure, is not perfect. As is normal in a democracy, the FDA has been buffeted by criticism and constant debate. Many critics say the agency is too lax, others say too hidebound and cautious. Some point to its industry ties. Some say its mandate is too big, but even its detractors admit that it is severely understaffed and underfunded, considering its enormous responsibilities. Anti-regulatory groups are quick to highlight its shortcomings. The fact is, the FDA lost many employees from 1994 to 2007, and only recently have they been replaced. Yet the agency is required to oversee thousands of products besides human drugs—including foods, cosmetics, the blood supply, medical devices, pet food, and pet drugs. Its computers are old, its information storage technology antiquated. Just as we need firefighters and police officers to do their essential jobs, we need the FDA to do its job. Still, the safety record of the FDA as a drug regulator is excellent, and U.S. drug manufacturers accept the need for high standards. Manufacturers in other counties presumably see the need for high standards, too.

A few positive steps?

There have been Senate hearings about the need for the FDA to improve its oversight of drugs being exported to the U.S. So far, though, according to a report to Congress from the General Accountability Office, there isn’t even reliable information about how many plants are involved or where they are. Nevertheless, the FDA has already opened its first small offices in Beijing, Shanghai, and Guangzhou, as well as India, Costa Rica, and some other drug-exporting nations. The U.S. Pharmacopeia (the standard-setting authority here) and the Chinese Pharmacopeia (a similar scientific organization) have signed an agreement promising cooperation. Other agencies are also beginning to tackle the problem. It is, of course, a huge and expensive job, and the U.S. cannot regulate and inspect every facility in the world. On the other hand, Americans expect their drugs to be safe, and can look only to the federal government to make them safe.

What you can do now

In fact, there isn’t a lot of practical, do-it-yourself advice at the moment. But it helps to be aware of a few things:

• The globalization of the pharmaceutical industry is not likely to reverse itself. Nations like Vietnam and Malaysia, for example, want to become drug exporters.

• The FDA needs more people. "Regulation" may be an unpopular idea in some quarters, but high manufacturing standards, rigorously enforced, are a necessity for our medicines. The better the regulation and oversight, the healthier and safer we’ll all be. This should not be a partisan issue.

• If you take prescription medications regularly, it won’t hurt to inspect your refills. Talk with your pharmacist, for instance, if a pill you usually cut in half splits too easily (or won’t split); if a drug you usually dissolve won’t dissolve; if a drug that has always worked is not working or causes some unexpected side effect; or if a drug seems different in any other way. There may be a perfectly good explanation, but a handful of reports have found that pills returned to the companies for testing are fake.

• "Imported" is not necessarily a dirty word. Some HIV drugs used in poor nations, for example, come from India—making them affordable. Lower prices can be life-savers, in poor countries as well as rich ones. We just need quality control.

UC Berkeley Wellness Letter, March 2010